Chronic PainIMPPPORTNCT04656340
Complementary and Integrative Pain Therapies and Functional Restoration (IMPPPORT) Trial)
A study testing non-medication, non-interventional therapies in people with Chronic Pain, run by Madigan Army Medical Center.
Trial summary
This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- non-medication, non-interventional therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2015to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Significant functional impairment due to pain, requiring modification of military duties.
- Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:
- Can stand up from and sit down on floor independently
- Can walk on treadmill for at least 6 minutes at 2.5 mile/hour pace or faster.
- Able to complete at least 2 of the following:
- Lift 20 lbs from floor to knuckle height
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- Lift 20 lbs from floor to shoulder height
- Carry 20lbs at least 40 feet.
- Inadequate response to previous less intensive treatment
- Expresses motivation to take active role in regaining function
Who cannot join
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
- High dose opioids of >120 milligrams of morphine equivalent doses (MED)/day
About this study
Official title: Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain
This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response.
SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology.
Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.
- Conditions
- Chronic Pain
- Being tested
- non-medication, non-interventional therapies
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-medication, non-interventional therapiesOther
Also called Standard rehabilitative therapies (SC) and Complementary and Integrative Health (CIH) therapies
non-medication, non-interventional therapies
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitative care (SC) | Active comparator | Twice weekly physical therapy, occupational therapy and pain psychoeducation Receives: Other: non-medication, non-interventional therapies |
| Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC) | Experimental | Twice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC Receives: Other: non-medication, non-interventional therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in Impact Score is computed by subtracting baseline Impact Score from the score at the time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to end of stage 2
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Secondary outcomes (75)
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to short-term post-treatment follow-up.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to intermediate-term post-treatment follow-up.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1
Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2
Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.
Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up
Walking tolerance on a treadmill using the modified Naughton treadmill protocol. Measured in minutes completed. Higher number of minutes indicates better status. Test terminates when pain intensity increases from level at start of treadmill testing. Change score is computed by subtracting the baseline number of minutes completed from the number of minutes completed at the time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 1. Improvement is indicated by change scores with positive values.
Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2
Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up
Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up
Measures how much weight in pounds study subject can comfortably lift from floor to waist height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.
Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.
Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.
Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.
Measures how much weight in pounds study subject can comfortably lift from waist to shoulder height. Higher number of lbs lifted indicates better status. Test terminates when pain intensity increases from start of lift test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds lifted from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1
Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.
Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.
Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.
Measures how much weight in pounds study subject can carry a distance of 40-feet. Higher number of lbs carried indicates better status. Test terminates when pain intensity increases from start of carry test. Change score is measured in pounds and is computed by subtracting the baseline number of pounds carried from the number of pounds lifted at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1
PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2
PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up
PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up
PROMIS Depression reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse depression. Change score is computed by subtracting baseline Depression T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.
PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.
PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up
PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up
PROMIS Anxiety reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anxiety T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1
PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
PROMIS Anger reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse anxiety. Change score is computed by subtracting baseline Anger T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse Sleep-related Impairment. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up
PROMIS Sleep-related Impairment reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better physical function. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.
PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2
PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to short-term post-treatment follow-up
PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to intermediate-term post-treatment follow-up
PROMIS Satisfaction with Social Roles reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate better satisfaction with social roles. Change score is computed by subtracting baseline Sleep-related Impairment T-score from T-score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Pain Catastrophizing Score (PCS), baseline to end of stage 1
PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Pain Catastrophizing Score (PCS), baseline to end of stage 2
PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Pain Catastrophizing Score (PCS), baseline to short-term follow-up
PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Pain Catastrophizing Score (PCS), baseline to intermediate-term follow-up
PCS is a 13-item questionnaire with a score range 0-52 with higher scores indicating worse status. Change score is computed by subtracting baseline PCS from PCS at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 1
CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to end of stage 2
CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to short-term follow-up
CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), baseline to intermediate-term follow-up
CPAQ-8 is an 8-item questionnaire with a score range 0-48 with higher scores indicating better status. Change score is computed by subtracting baseline CPAQ-8 score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 1
PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to end of stage 2
PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to short-term follow-up
PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Pain Self-Efficacy Questionnaire (PSEQ), baseline to intermediate-term follow-up
PSEQ is a 10-item questionnaire with a score range 0-60 with higher scores indicating better status. Change score is computed by subtracting baseline PSEQ score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Patient Activation Measure (PAM), baseline to end of stage 1
PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Patient Activation Measure (PAM), baseline to end of stage 2
PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Patient Activation Measure (PAM), baseline to short-term follow-up
PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Patient Activation Measure (PAM), baseline to intermediate-term follow-up
PAM a 10-item questionnaire with a score range 10-40 with higher scores indicating better status. Change score is computed by subtracting baseline PAM score from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 1
TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to end of stage 2
TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to short-term follow-up
TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Tampa Kinesiophobia Score-11 (TSK-11), baseline to intermediate-term follow-up
TSK-11 an 11-item questionnaire with a score range 11-44 with higher scores indicating worse status. Change score is computed by subtracting baseline TSK-11 score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to end of stage 1
RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to of stage 2
RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to short-term follow-up
RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Roland-Morris Disability Questionnaire (RMDQ), baseline to intermediate-term follow-up
RMDQ a 24-item questionnaire with a score range 0-24 with higher scores indicating worse status. Change score is computed by subtracting baseline RMDQ score from score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Patient Global Impression of Change (PGIC) at end of Stage 2
PGIC is a one-item questionnaire that determines the study subjects' assessment on their level of improvement or worsening since the start of treatment. Responses are on a likert scale from very much improved; much improved; minimally improved; no change; minimally worse; much worse; very much worse
Measured: End of Stage 2 timeline parameters as stated for outcomes 2
Change in Pyramid Measure, baseline to end of stage 1
7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in Pyramid Measure, baseline to end of stage 2
7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in Pyramid Measure, baseline to short-term follow-up
7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in Pyramid Measure, baseline to intermediate-term follow-up
7-to-1 Pyramid Test is a functional performance test that measures the number of repetitions a person can do of sets of pushups, back extensions, rowers, squats, dips, and burpees. The total score is the total repetitions completed within 5 minutes. The minimum score is zero repetitions; there is no maximum number of repetitions. A higher number of repetitions indicates better functional status. Change score is computed by subtracting baseline number or repetitions from score at time of reassessment. Improvement is indicated by change scores with positive values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 1
PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of stage 2
PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to end of short-term follow-up
PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Fatigue, baseline to intermediate-term follow-up
PROMIS Fatigue reported in T-score, range 0-100, with 50 corresponding to the mean score and higher scores indicate worse fatigue. Change score is computed by subtracting baseline Fatigue T-score from T-score at time of reassessment. Improvement is indicated by change scores with negative values.
Measured: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start9 Dec 2015
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, University of Washington, National Institute of Nursing Research (NINR), Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Principal investigator, Diane Flynn, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656340
- Sponsor's protocol ID
- 215050
- Other IDs
- DM140424, K24NR015340
- Acronym
- IMPPPORT
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2020
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flynn DM, McQuinn H, Fairchok A, Eaton LH, Langford DJ, Snow T, Doorenbos AZ. Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain. Contemp Clin Trials Commun. 2018 Nov 29;13:100311. doi: 10.1016/j.conctc.2018.100311. eCollection 2019 Mar.
PubMed 30582069Flynn DM, McQuinn H, Burke L, Steffen A, Fairchok A, Snow T, Doorenbos AZ. Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain. Pain Med. 2022 Apr 8;23(4):844-856. doi: 10.1093/pm/pnab326.
PubMed 34791423
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Success of Functional Restoration Using Integrative Pain Therapies: a Comparative Effectiveness Analysis of Active Duty Service Members With Chronic Pain
- ClinicalTrials.gov ID
- NCT04656340
- Acronym / sponsor ID
- IMPPPORT / 215050
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- U.S. Army Medical Research and Development Command, University of Washington, National Institute of Nursing Research (NINR), Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 9 Dec 2015 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the benefit of a complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SC) compared to SC alone prior to an intensive functional restoration (FR) program in a population of active duty service members. In addition the study aims to identify factors that predict improvement in pain impact following treatment, and to determine the proportion of participants who experience clinically meaningful response.
SC included physical and occupational therapy. CIH included chiropractic, acupuncture, yoga and foam roller instruction. Both treatment groups also received education about pain psychology.
Participants were randomly assigned to a 3-week course of either SC alone or CIH combined with SC prior to a 3-week course of FR. Outcomes were collected at baseline, at end of stage 1, and post-FR. Outcomes included patient-reported and provider-determined measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitative care (SC) | Active comparator | Other: non-medication, non-interventional therapiesTwice weekly physical therapy, occupational therapy and pain psychoeducation |
| Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC) | Experimental | Other: non-medication, non-interventional therapiesTwice weekly chiropractic, acupuncture, yoga and foam roller instruction, in addition to SC |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Significant functional impairment due to pain, requiring modification of military duties.
- Physically able to participate in up to four hours of physical activity (strength, flexibility, endurance training) per day:
- Inadequate response to previous less intensive treatment
- Expresses motivation to take active role in regaining function
Key exclusion criteria (4 listed)
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
- High dose opioids of >120 milligrams of morphine equivalent doses (MED)/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-medication, non-interventional therapiesAlso: Standard rehabilitative therapies (SC) and Complementary and Integrative Health (CIH) therapiesnon-medication, non-interventional therapies | Other | Complementary and Integrative Health (CIH) therapies in addition to Standard rehabilitate care (SC), Standard rehabilitative care (SC) |
Primary outcome
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in Impact Score is computed by subtracting baseline Impact Score from the score at the time of reassessment. Improvement is indicated by change scores with negative values.
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 2 treatment
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
The RTF Impact score is was computed by adding the following three scores: 1) average pain intensity (range 0=no pain - 10=worst pain) from the Defense and Veterans Pain Rating Scale (DVPRS); 2) the NIH Patient Reported Outcome Measures Information System (PROMIS) pain interference score (range 4-20 with higher scores indicating worse status; 3) the REVERSE of the PROMIS physical function scores (range 4-20 with higher score indicating better status and higher score on reverse scale indicating worse status). The range of RTF impact score is 8 (best) -50 (worst). Change in RTF Impact Score from baseline to end of stage 2
75 secondary outcomes
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - short-term follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - intermediate-term follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 1
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in walking tolerance from baseline to end of stage 2
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to short-term post-treatment follow-up.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in walking tolerance from baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 1. Improvement is indicated by change scores with positive values.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of Stage 2
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of short-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in floor-to-waist lifting tolerance from baseline to end of intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-1.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to end of stage-2.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to short-term post-treatment follow-up.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in waist-shoulder lifting tolerance from baseline to intermediate-term post-treatment follow-up.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 1
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to end of stage 2.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to short-term post-treatment follow-up.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Battery of functional performance measures - Change in 40-foot carry tolerance from baseline to intermediate-term post-treatment follow-up.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 1
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to end of stage 2
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to short-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Depression - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 1.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to end of stage 2.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to short-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anxiety - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to end of stage 1
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Anger - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 1
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to end of stage 2
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to short-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Sleep-related Impairment - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 1.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to end of stage 2.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to short-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Short-term follow-up measures collected between 1 month through <5 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Physical Function - baseline to intermediate-term post-treatment follow-up
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. Intermediate-term follow-up measures collected between >6 month through <9 months after end of stage 2.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 1.
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.
Change in NIH Patient Reported Outcome Measures Information System (PROMIS) Satisfaction with Social Roles - baseline to end of stage 2
Time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of Stage 2 measures collected between </=2 treatment days before end of stage 2 through 30 days after end of stage 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 30582069Flynn DM, McQuinn H, Fairchok A, Eaton LH, Langford DJ, Snow T, Doorenbos AZ. Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain. Contemp Clin Trials Commun. 2018 Nov 29;13:100311. doi: 10.1016/j.conctc.2018.100311. eCollection 2019 Mar.
- Derived from this study: PubMed 34791423Flynn DM, McQuinn H, Burke L, Steffen A, Fairchok A, Snow T, Doorenbos AZ. Use of Complementary and Integrative Health Therapies Before Intensive Functional Restoration in Active Duty Service Members with Chronic Pain. Pain Med. 2022 Apr 8;23(4):844-856. doi: 10.1093/pm/pnab326.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing non-medication, non-interventional therapies in people with Chronic Pain, run by Madigan Army Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institutes of Health (NIH) Research Task Force (RTF) Impact Score - baseline to end of stage 1 treatment (time frame: Baseline collected between 3 months before start of stage 1 through 2 days after start of Stage 1. End of stage 1 measures collected between </=2 treatment days before end of stage 1 through 4 treatment days after end of stage 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.