Chronic PainNCT03297905
Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
A study testing Complementary and Integrative Therapies and Standard Rehabilitative Care in people with Chronic Pain, run by University of Washington at 1 site in United States.
Trial summary
This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Complementary and Integrative Therapies and Standard Rehabilitative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 31 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active duty service members
- Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
- Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities
Who cannot join
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
This study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.
Read the detailed description
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.
The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.
Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.
Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.
Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.
Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.
Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
- Conditions
- Chronic Pain
- Being tested
- Complementary and Integrative Therapies, Standard Rehabilitative Care
- Keywords
- Chronic Pain, Military
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary and Integrative TherapiesBehavioural
Intervention time period is 3 - 6 weeks.
Standard Rehabilitative CareBehavioural
Intervention time period is 3 - 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Complementary and Integrative Therapies | Experimental | Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction Receives: Behavioral: Complementary and Integrative Therapies |
| Standard Rehabilitative Care | Active comparator | Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy Receives: Behavioral: Standard Rehabilitative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Intensity
Pain Intensity 10-pt Numeric Rating Scale
Measured: 3 months
Change from Baseline Pain Impact
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
Measured: 3 months
Secondary outcomes (18)
Depression
Patient Reported Outcome Measurement Information System
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Anxiety
Patient Reported Outcome Measurement Information System
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Emotional Distress - Anger
Patient Reported Outcome Measurement Information System
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Sleep Disturbance
Patient Reported Outcome Measurement Information System
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Fatigue
Patient Reported Outcome Measurement Information System
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
PTSD
Primary Care PTSD Screen
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Activation Measure
A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Drug Use
Drug Use Questionnaire
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing
Pain Catastrophizing Scale
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Kinesiophobia
Tampa Scale for Kinesiophobia
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self-Efficacy
Pain Self Efficacy Questionnaire
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance
Chronic Pain Acceptance Questionnaire
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Functional Capacity
Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization
Opioid Utilization Screener
Measured: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Cortisol
Salivary Cortisol
Measured: baseline, 6 weeks
Oxidative Stress
Urine Sample
Measured: baseline, 6 weeks
Genomic DNA
Buccal Sample
Measured: baseline
Army Physical Fitness Test (APFT)
Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
Measured: baseline, 6 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start15 Jun 2018
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Madigan Army Medical Center
- Responsible party
- Principal investigator, Ardith Doorenbos, University of Washington
- Investigators
- Ardith Z Doorenbos, RN, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297905
- Sponsor's protocol ID
- STUDY00004220
- Status last verified
- Oct 2022
- First submitted
- 8 Aug 2017
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Snow TJ, Shimada S, Ieronimakis N, Tintle N, Flynn DM, Wi D, Ransom JC, McQuinn HM, Doorenbos AZ. Association of physical function and sleep with oxidative stress in adults with chronic pain: A pragmatic clinical trial secondary analysis. J Int Med Res. 2026 May;54(5):3000605261451958. doi: 10.1177/03000605261451958. Epub 2026 May 31.
PubMed 42219238Tintle NL, Ryder NA, Westra J, Wi D, Shimada S, Ieronimakis N, McQuinn HM, Snow TJ, Doorenbos AZ, Flynn DM. CYP gene variants show preliminary evidence of association with patient-reported outcomes in active-duty service members with chronic pain. Mol Pain. 2026 Jan-Dec;22:17448069261454823. doi: 10.1177/17448069261454823. Epub 2026 May 23.
PubMed 42175782Shimada S, Ledesma S, Flynn DM, Tintle N, Ransom JC, McQuinn HM, Snow TJ, Ieronimakis N, Wi D, Burke LA, Steffen AD, Doorenbos AZ. Evaluating Sex Differences in Biomarkers of Chronic Pain Among Active-Duty Personnel: An Exploratory Analysis of a Pragmatic Clinical Trial With a SMART Design. Biol Res Nurs. 2026 Jul;28(3):384-394. doi: 10.1177/10998004261423210. Epub 2026 Feb 3.
PubMed 41631713Wi D, Flynn DM, Park C, Ransom JC, McQuinn HM, Snow TJ, Burke LA, Steffen AD, Shimada S, Doorenbos AZ. Dynamic Interactions in Chronic Pain-Related Outcomes: A Secondary Data Analysis of a Pragmatic Clinical Trial With Sequential, Multiple Assignment, Randomized Trial Design. Mil Med. 2025 Nov 1;190(11-12):e2382-e2390. doi: 10.1093/milmed/usaf225.
PubMed 40440185Flynn DM, Ransom JC, Steffen AD, Orr KP, McQuinn HM, Snow TJ, Burke LA, Wi D, Doorenbos AZ. Complementary, integrative, and standard rehabilitative therapies in a military population with chronic predominantly musculoskeletal pain: a pragmatic clinical trial with SMART design. Pain. 2025 Jun 1;166(6):1343-1353. doi: 10.1097/j.pain.0000000000003462. Epub 2024 Nov 8.
PubMed 39560398Wi D, Ransom JC, Flynn DM, Steffen AD, Park C, Burke LA, Doorenbos AZ. Role of Pain Catastrophizing in the Effects of Cognitive Behavioral Therapy for Chronic Pain in Different Subgroups: An Exploratory Secondary Data Analysis Using Finite Mixture Models. Mil Med. 2024 Nov 5;189(11-12):e2600-e2607. doi: 10.1093/milmed/usae288.
PubMed 38829170
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury
- ClinicalTrials.gov ID
- NCT03297905
- Acronym / sponsor ID
- STUDY00004220
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Military
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Madigan Army Medical Center
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Sep 2017 (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 will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.
Detailed description
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of disability among active duty military Service members. The injury rate is significant with 628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service members. Neuromusculoskeletal injuries include amputations following battlefield trauma, repetitive motion injuries related to equipment use or weight-bearing postures, and even injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on both individual Service members and military readiness are significant: Only 13% of Service members being treated primarily for pain ever return to the field.
The Department of Defense (DoD) has recently expanded its capacity to provide both functional restoration (FR) and complementary and integrative medicine (CIM) therapies for neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine the most effective treatment combination, sequence, and duration of standard rehabilitative care (SRC), such as physical and occupational therapy in combination with cognitive behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service members preparing to enroll in an intensive FR program that is currently the DoD-recommended treatment. In addition, this study aims to identify ways to predict in advance which patients will respond best to which therapeutic regimens.
Potential Impact. This research has the potential to determine which patients are most likely to benefit from the non-medication pain therapies currently available in all Army Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively be combined to achieve the greatest improvements in pain impact, quality of life and ability to return to duty following injury.
Patients Who Will Benefit. This study will involve active duty Service members referred to an Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans Health Administration (VHA) pain management centers so that active duty Service members and veterans across United States may benefit from a treatment approach that is tailored to their individual characteristics. It is anticipated that the knowledge gained through this research will be applicable to family members of Service members and veterans and will ultimately lead to expansion of TRICARE benefits to include CIM therapies.
Potential Clinical Applications, Benefits, and Risks. This research will assist providers in determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the needs of each patient. Service members and veterans will benefit by being referred for these approaches when appropriate during the course of disabling chronic pain conditions. Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record to guide health care providers to consider referral for these therapies in patients who may benefit. This study will advance our ability to effectively tailor therapies for rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest benefit in physical function and quality of life. The risks of these interventions are minimal; Service members may experience general muscle soreness for the first week or so of increased physical activity, but this typically resolves.
Projected Timeline. This research will determine the optimal combination, sequence, and duration of therapies. It is expected that some active duty Service members could see improvements in function and quality of life within three weeks, but others may require up to six weeks to experience meaningful improvement.
Benefit to Military Personnel. This research will benefit Service members experiencing pain due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies most likely to yield meaningful improvements in function and quality of life, and thus facilitate their return to duty. The recommendations from this study will be shared with pain management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial (SMART)
| Arm | Type | Receives |
|---|---|---|
| Complementary and Integrative Therapies | Experimental | Behavioral: Complementary and Integrative TherapiesChiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction |
| Standard Rehabilitative Care | Active comparator | Behavioral: Standard Rehabilitative CareCognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active duty service members
- Neuromusculoskeletal or neuropathic pain ≥ 3-months duration
- Pain of sufficient severity to bring about dysfunction in daily social, vocational, and/or interpersonal activities
Key exclusion criteria (3 listed)
- Major surgeries within past 6 months or planned within next 6 months
- Unstable psychological disorders
- Active substance use disorder
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 |
|---|---|---|
| Complementary and Integrative TherapiesIntervention time period is 3 - 6 weeks. | Behavioural | Complementary and Integrative Therapies |
| Standard Rehabilitative CareIntervention time period is 3 - 6 weeks. | Behavioural | Standard Rehabilitative Care |
Primary outcome
Change from Baseline Pain Intensity
Time frame: 3 months
Pain Intensity 10-pt Numeric Rating Scale
Change from Baseline Pain Impact
Time frame: 3 months
Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
18 secondary outcomes
Depression
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Anxiety
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Emotional Distress - Anger
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Sleep Disturbance
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Fatigue
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
PTSD
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Patient Activation Measure
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Drug Use
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Catastrophizing
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Kinesiophobia
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Pain Self-Efficacy
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Chronic Pain Acceptance
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Functional Capacity
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Opioid Utilization
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
Cortisol
Time frame: baseline, 6 weeks
Oxidative Stress
Time frame: baseline, 6 weeks
Genomic DNA
Time frame: baseline
Army Physical Fitness Test (APFT)
Time frame: baseline, 6 weeks, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 42219238Snow TJ, Shimada S, Ieronimakis N, Tintle N, Flynn DM, Wi D, Ransom JC, McQuinn HM, Doorenbos AZ. Association of physical function and sleep with oxidative stress in adults with chronic pain: A pragmatic clinical trial secondary analysis. J Int Med Res. 2026 May;54(5):3000605261451958. doi: 10.1177/03000605261451958. Epub 2026 May 31.
- Derived from this study: PubMed 42175782Tintle NL, Ryder NA, Westra J, Wi D, Shimada S, Ieronimakis N, McQuinn HM, Snow TJ, Doorenbos AZ, Flynn DM. CYP gene variants show preliminary evidence of association with patient-reported outcomes in active-duty service members with chronic pain. Mol Pain. 2026 Jan-Dec;22:17448069261454823. doi: 10.1177/17448069261454823. Epub 2026 May 23.
- Derived from this study: PubMed 41631713Shimada S, Ledesma S, Flynn DM, Tintle N, Ransom JC, McQuinn HM, Snow TJ, Ieronimakis N, Wi D, Burke LA, Steffen AD, Doorenbos AZ. Evaluating Sex Differences in Biomarkers of Chronic Pain Among Active-Duty Personnel: An Exploratory Analysis of a Pragmatic Clinical Trial With a SMART Design. Biol Res Nurs. 2026 Jul;28(3):384-394. doi: 10.1177/10998004261423210. Epub 2026 Feb 3.
- Derived from this study: PubMed 40440185Wi D, Flynn DM, Park C, Ransom JC, McQuinn HM, Snow TJ, Burke LA, Steffen AD, Shimada S, Doorenbos AZ. Dynamic Interactions in Chronic Pain-Related Outcomes: A Secondary Data Analysis of a Pragmatic Clinical Trial With Sequential, Multiple Assignment, Randomized Trial Design. Mil Med. 2025 Nov 1;190(11-12):e2382-e2390. doi: 10.1093/milmed/usaf225.
- Derived from this study: PubMed 39560398Flynn DM, Ransom JC, Steffen AD, Orr KP, McQuinn HM, Snow TJ, Burke LA, Wi D, Doorenbos AZ. Complementary, integrative, and standard rehabilitative therapies in a military population with chronic predominantly musculoskeletal pain: a pragmatic clinical trial with SMART design. Pain. 2025 Jun 1;166(6):1343-1353. doi: 10.1097/j.pain.0000000000003462. Epub 2024 Nov 8.
- Derived from this study: PubMed 38829170Wi D, Ransom JC, Flynn DM, Steffen AD, Park C, Burke LA, Doorenbos AZ. Role of Pain Catastrophizing in the Effects of Cognitive Behavioral Therapy for Chronic Pain in Different Subgroups: An Exploratory Secondary Data Analysis Using Finite Mixture Models. Mil Med. 2024 Nov 5;189(11-12):e2600-e2607. doi: 10.1093/milmed/usae288.
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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.
Ardith Z Doorenbos, RN, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary and Integrative Therapies and Standard Rehabilitative Care in people with Chronic Pain, run by University of Washington at 1 site in United States.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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 from Baseline Pain Intensity (time frame: 3 months). 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 NCT03297905, which also lists 6 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 12 Oct 2022.