Musculoskeletal PainACTIONNCT01983228
A Proactive Walking Trial to Reduce Pain in Black Veterans
A study testing Intervention Condition in people with Musculoskeletal Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Intervention Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must receive care at the Atlanta VAMC and
- have back, hip or knee pain for a duration of at least 6 months,
- moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater),
- self-reported ability to walk at least 1 block, and
- must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.
Who cannot join
- The investigators will not include any vulnerable populations or those who meet any of the following exclusion criteria that may interfere with the outcome assessment: a) moderately severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients who say they are unable to walk at least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) patients with active psychotic symptoms, suicidality, and/or active manic episode or poorly controlled bipolar disorder, as determined by chart review.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.
Read the detailed description
BACKGROUND/RATIONALE:
Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors.
OBJECTIVES:
The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK.
METHODS:
The investigators propose a randomized trial to test the effectiveness of the intervention compared with usual care (UC) among 500 patients with chronic MSK pain, with a minimum of 250 Black participants. Patients from the Atlanta VAMC will be identified using administrative data. Patients will be screened by phone, and, if eligible, will be mailed the baseline survey to complete and mail back. Eligible patients who complete the baseline survey will be randomly assigned to the usual care (UC) or intervention condition (IC). Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months. Patients in the UC condition will receive an informational brochure and a pedometer. The study is powered to find a difference between the IC and UC groups within the black and non-black groups. The primary outcome is chronic pain-related physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining potential mediators targeted by the intervention, exploring whether the intervention affects service utilization and use of opioid analgesics, and exploring whether the intervention reduces racial disparities in pain outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6 months. Data analysis of primary aims will follow intent-to-treat methodology.
FINDINGS:
None at this time.
STATUS:
Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus groups provided valuable information that led us to refine our recruitment materials. Focus groups also yielded important information for our counselors, including potential communication barriers and barriers to walking. During January - April 2016, we conducted a pilot test of our intervention with 3 participants. We began the trial on July 2016. Recruitment and randomization were completed in June 2019. The intervention activities were completed in September 2019. Follow-up survey data collection is currently ongoing.
IMPACT:
The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking.
- Conditions
- Musculoskeletal Pain
- Being tested
- Intervention Condition
- Keywords
- Musculoskeletal Pain, Walking, African American, Telephone Coaching, Pedometer
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ConditionBehavioural
Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Usual Care | No intervention | Participants randomized to the usual care control condition will receive pedometers and an informational brochure. |
| Arm 2: Intervention Group | Experimental | Participants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. Receives: Behavioral: Intervention Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 6-month follow-up period.
Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.
Measured: Assessed at baseline and 6 months
Secondary outcomes (11)
Change in Brief Pain Intensity Scale at 6 Months
Pain intensity assessed by change in Brief Pain Intensity Scale at 6 months. Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Measured: Baseline and 6 months
Change in Generalized Anxiety Disorder at 6 Months
Change in Generalized Anxiety Disorder assessed by 7-item Generalized Anxiety Disorder scale (GAD-7) Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Measured: Baseline and 6 months
Change in Depression at 6 Months
Change in Depression at 6 months assessed by 8-item Patient Health Questionnaire (PHQ-8).
Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 6 months.
Measured: Baseline and 6 months
Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months
Single item measure of patient global impression of change. The investigators will assess this outcome at 6 months. Min=1, max=7, higher scores indicate worse outcome.
Measured: 6 months
Mean Change in Average Daily Total Steps at 6 Months
Pedometer data recorded over past 7 days on patient logs The investigators will assess mean change in this outcome from baseline to 6 months.
Measured: baseline and 6 months
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months
30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 3-month follow-up period.
Minimum = 0 Maximum = 11 Higher scores indicate greater disability The investigators will assess change in this outcome from baseline to 3 months.
Measured: Baseline and 3 months
Change in Brief Pain Intensity Scale at 3 Months
Pain intensity assessed by Brief Pain Intensity Scale Min=0, max=10, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Measured: Baseline and 3 months
Change in Generalized Anxiety Disorder, at 3 Months
Change in Generalized Anxiety Disorder (GAD-7). Min=0, max=21, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Measured: Baseline and 3 months
Change in Depression Using 3 Month
Change in Depression at 3 months using the 8-item Patient Health Questionnaire (PHQ-8) Min=0, max=24, higher scores indicate worse outcome. The investigators will assess change in this outcome from baseline to 3 months.
Measured: Baseline and 3 months
Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months
Single item measure of patient global impression of change. The investigators will assess this outcome using the 3-month assessment. Min=1, max=7, higher scores indicate worse outcome
Measured: 3 months
Mean Change in Average Daily Total Steps, at 3 Months
Pedometer data recorded over past 7 days on patient logs. The investigators will assess mean change in this outcome from baseline to 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start1 Jul 2016
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Parallel groups
- Model description
- Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Diana J. Burgess, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983228
- Sponsor's protocol ID
- IIR 13-030
- Acronym
- ACTION
- Status last verified
- Jul 2023
- First submitted
- 6 Nov 2013
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhimani RH, Cross LJ, Taylor BC, Meis LA, Fu SS, Allen KD, Krein SL, Do T, Kerns RD, Burgess DJ. Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans. BMC Musculoskelet Disord. 2017 Jan 13;18(1):15. doi: 10.1186/s12891-016-1363-6.
PubMed 28086853Burgess DJ, Hagel Campbell E, Hammett P, Allen KD, Fu SS, Heapy A, Kerns RD, Krein SL, Meis LA, Bangerter A, Cross LJS, Do T, Saenger M, Taylor BC. Taking ACTION to Reduce Pain: a Randomized Clinical Trial of a Walking-Focused, Proactive Coaching Intervention for Black Patients with Chronic Musculoskeletal Pain. J Gen Intern Med. 2022 Nov;37(14):3585-3593. doi: 10.1007/s11606-021-07376-2. Epub 2022 Feb 7.
PubMed 35132545Hammett PJ, Eliacin J, Makris UE, Allen KD, Kerns RD, Heapy A, Goldsmith ES, Meis LA, Taylor BC, Saenger M, Cross LJS, Do T, Branson M, Burgess DJ. An Analysis of the Role of Mental Health in a Randomized Trial of a Walking Intervention for Black Veterans With Chronic Pain. J Pain. 2023 Jan;24(1):55-67. doi: 10.1016/j.jpain.2022.07.002. Epub 2022 Sep 23.
PubMed 36162790Hammett PJ, Eliacin J, Saenger M, Allen KD, Meis LA, Krein SL, Taylor BC, Branson M, Fu SS, Burgess DJ. The Association Between Racialized Discrimination in Health Care and Pain Among Black Patients With Mental Health Diagnoses. J Pain. 2024 Jan;25(1):217-227. doi: 10.1016/j.jpain.2023.08.004. Epub 2023 Aug 15.
PubMed 37591480
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proactive Walking Trial to Reduce Pain in Black Veterans
- ClinicalTrials.gov ID
- NCT01983228
- Acronym / sponsor ID
- ACTION / IIR 13-030
- Conditions
- Musculoskeletal Pain
- Keywords
- Musculoskeletal Pain, Walking, African American, Telephone Coaching, Pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 9 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.
Detailed description
BACKGROUND/RATIONALE:
Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors.
OBJECTIVES:
The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK.
METHODS:
The investigators propose a randomized trial to test the effectiveness of the intervention compared with usual care (UC) among 500 patients with chronic MSK pain, with a minimum of 250 Black participants. Patients from the Atlanta VAMC will be identified using administrative data. Patients will be screened by phone, and, if eligible, will be mailed the baseline survey to complete and mail back. Eligible patients who complete the baseline survey will be randomly assigned to the usual care (UC) or intervention condition (IC). Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months. Patients in the UC condition will receive an informational brochure and a pedometer. The study is powered to find a difference between the IC and UC groups within the black and non-black groups. The primary outcome is chronic pain-related physical functioning, assessed by the revised Roland and Morris Disability Questionnaire, a measure recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will also examine whether the intervention improves other IMMPACT-recommended domains (pain intensity, emotional functioning, and ratings of overall improvement). Secondary objectives include examining potential mediators targeted by the intervention, exploring whether the intervention affects service utilization and use of opioid analgesics, and exploring whether the intervention reduces racial disparities in pain outcomes. Measures will be assessed by mail and phone survey at baseline, 3 months, and 6 months. Data analysis of primary aims will follow intent-to-treat methodology.
FINDINGS:
None at this time.
STATUS:
Focus groups were conducted at the Atlanta VAMC in September and October 2015. These focus groups provided valuable information that led us to refine our recruitment materials. Focus groups also yielded important information for our counselors, including potential communication barriers and barriers to walking. During January - April 2016, we conducted a pilot test of our intervention with 3 participants. We began the trial on July 2016. Recruitment and randomization were completed in June 2019. The intervention activities were completed in September 2019. Follow-up survey data collection is currently ongoing.
IMPACT:
The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention participants will receive a pedometer-mediated walking intervention that will incorporate Action Planning and the use of MI and CBT techniques. The intervention will be delivered in 6 telephone counseling sessions over three months.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care | No intervention | –Participants randomized to the usual care control condition will receive pedometers and an informational brochure. |
| Arm 2: Intervention Group | Experimental | Behavioral: Intervention ConditionParticipants assigned to the intervention group will receive personalized recruitment materials, including a letter and brochure describing the program and the benefits of walking for pain. They will also receive pedometers. Participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible patients must receive care at the Atlanta VAMC and
- have back, hip or knee pain for a duration of at least 6 months,
- moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater),
- self-reported ability to walk at least 1 block, and
- must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.
Key exclusion criteria (1 listed)
- The investigators will not include any vulnerable populations or those who meet any of the following exclusion criteria that may interfere with the outcome assessment: a) moderately severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients who say they are unable to walk at least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) patients with active psychotic symptoms, suicidality, and/or active manic episode or poorly controlled bipolar disorder, as determined by chart review.
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 |
|---|---|---|
| Intervention ConditionIntervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study. | Behavioural | Arm 2: Intervention Group |
Primary outcome
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
Time frame: Assessed at baseline and 6 months
30% improvement on the Roland Morris Disability Questionnaire [RMDQ]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.
11 secondary outcomes
Change in Brief Pain Intensity Scale at 6 Months
Time frame: Baseline and 6 months
Change in Generalized Anxiety Disorder at 6 Months
Time frame: Baseline and 6 months
Change in Depression at 6 Months
Time frame: Baseline and 6 months
Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months
Time frame: 6 months
Mean Change in Average Daily Total Steps at 6 Months
Time frame: baseline and 6 months
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months
Time frame: Baseline and 3 months
Change in Brief Pain Intensity Scale at 3 Months
Time frame: Baseline and 3 months
Change in Generalized Anxiety Disorder, at 3 Months
Time frame: Baseline and 3 months
Change in Depression Using 3 Month
Time frame: Baseline and 3 months
Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months
Time frame: 3 months
Mean Change in Average Daily Total Steps, at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28086853Bhimani RH, Cross LJ, Taylor BC, Meis LA, Fu SS, Allen KD, Krein SL, Do T, Kerns RD, Burgess DJ. Taking ACTION to reduce pain: ACTION study rationale, design and protocol of a randomized trial of a proactive telephone-based coaching intervention for chronic musculoskeletal pain among African Americans. BMC Musculoskelet Disord. 2017 Jan 13;18(1):15. doi: 10.1186/s12891-016-1363-6.
- Results publication: PubMed 35132545Burgess DJ, Hagel Campbell E, Hammett P, Allen KD, Fu SS, Heapy A, Kerns RD, Krein SL, Meis LA, Bangerter A, Cross LJS, Do T, Saenger M, Taylor BC. Taking ACTION to Reduce Pain: a Randomized Clinical Trial of a Walking-Focused, Proactive Coaching Intervention for Black Patients with Chronic Musculoskeletal Pain. J Gen Intern Med. 2022 Nov;37(14):3585-3593. doi: 10.1007/s11606-021-07376-2. Epub 2022 Feb 7.
- Results publication: PubMed 36162790Hammett PJ, Eliacin J, Makris UE, Allen KD, Kerns RD, Heapy A, Goldsmith ES, Meis LA, Taylor BC, Saenger M, Cross LJS, Do T, Branson M, Burgess DJ. An Analysis of the Role of Mental Health in a Randomized Trial of a Walking Intervention for Black Veterans With Chronic Pain. J Pain. 2023 Jan;24(1):55-67. doi: 10.1016/j.jpain.2022.07.002. Epub 2022 Sep 23.
- Derived from this study: PubMed 37591480Hammett PJ, Eliacin J, Saenger M, Allen KD, Meis LA, Krein SL, Taylor BC, Branson M, Fu SS, Burgess DJ. The Association Between Racialized Discrimination in Health Care and Pain Among Black Patients With Mental Health Diagnoses. J Pain. 2024 Jan;25(1):217-227. doi: 10.1016/j.jpain.2023.08.004. Epub 2023 Aug 15.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
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.
Diana J. Burgess, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Condition in people with Musculoskeletal Pain, run by VA Office of Research and Development 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 5 inclusion and 1 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 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months (time frame: Assessed at baseline and 6 months). 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 NCT01983228, which also lists 4 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 27 Jul 2023.