Chronic PainSTOMPNCT03692611
Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
A study testing Skills TO Manage Pain (STOMP) and Comparison group in people with Chronic Pain, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Skills TO Manage Pain (STOMP) and Comparison group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2019to 6 Jan 2025
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in CNICS
- Age ≥ 18 years
- English-speaking
- Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)
- Ability and willingness to attend the group sessions at the date/time specified
- No plans for major surgery during the study period that would interfere with study procedures.
Who cannot join
- Do not speak or understand English
- Are planning a new pain treatment like surgery
- Cannot attend the group sessions
- Had previously participated in the pilot study (STOMP)
- Unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama
Birmingham, Alabama, 352940
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.
Read the detailed description
Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose. In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible. The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PLWH. The investigators will accomplish the overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given the investigators' rigorous intervention development process and promising pilot trial results, the working hypothesis is that STOMP will decrease pain and improve function in PLWH. Investigators also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on the investigators' formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.
- Conditions
- Chronic Pain
- Being tested
- Skills TO Manage Pain (STOMP), Comparison group
- Keywords
- Chronic pain, HIV, Opioid prescribing, Behavioral clinical trial
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills TO Manage Pain (STOMP)Behavioural
12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
Comparison groupBehavioural
Also called active comparator
Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
| Study group | Role | What they receive |
|---|---|---|
| Skills to Manage Pain (STOMP) | Experimental | The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session. Receives: Behavioral: Skills TO Manage Pain (STOMP) |
| comparison group | Active comparator | The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention. Receives: Behavioral: Comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Total Score
The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
Secondary outcomes (6)
Brief Pain Inventory (BPI) Functional Interference Subscore
The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
Brief Pain Inventory (BPI) Pain Severity Subscore
The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
The Pain, Enjoyment and General Activity (PEG) Scale
The Pain, Enjoyment and General Activity (PEG) scale measures pain severity and enjoyment of activities with scores ranging from 0 to 10. Higher scores indicate worse pain and greater interference with daily activities. The total score is the average of 3 items assessing pain intensity, enjoyment of life, and general activity.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
The Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) assesses an individual's confidence in their ability to perform daily activities despite pain. The total score is the sum of 10 items, each rated from 0 to 6, resulting in a range of 0 to 60. Higher scores indicate greater self-efficacy and a stronger belief in one's ability to manage daily tasks while experiencing pain.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
The Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms over the past two weeks. Each item is rated from 0 to 3, with the total score (0-24) calculated by adding all responses, with higher scores indicating more severe depressive symptoms and a worse mental health outcome.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
The Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure assessing exaggerated negative thoughts and feelings about pain. Each item is rated from 0 to 4, with the total score (0-52) calculated by summing all responses. Higher scores indicate greater pain catastrophizing and worse psychological outcomes related to pain.
Measured: Immediately postintervention and 3-month follow-up (postintervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start14 Aug 2019
- Primary completion14 Jan 2024
- Study completion6 Jan 2025
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 (93)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 PittsburghThe 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
- This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Jessica Merlin, University of Pittsburgh
- Investigators
- Jessica Merlin, MD PhD MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692611
- Sponsor's protocol ID
- STUDY19050051
- Other IDs
- 1R01MH115754-01A1
- Acronym
- STOMP
- Status last verified
- Mar 2025
- First submitted
- 7 Sep 2018
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215.
PubMed 22766967Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.
PubMed 28880698Merlin JS, Westfall AO, Chamot E, Overton ET, Willig JH, Ritchie C, Saag MS, Mugavero MJ. Pain is independently associated with impaired physical function in HIV-infected patients. Pain Med. 2013 Dec;14(12):1985-93. doi: 10.1111/pme.12255. Epub 2013 Oct 9.
PubMed 24119077Robinson-Papp J, Sharma S, Dhadwal N, Simpson DM, Morgello S. Optimizing measures of HIV-associated neuropathy. Muscle Nerve. 2015 Jan;51(1):56-64. doi: 10.1002/mus.24282. Epub 2014 Nov 21.
PubMed 24809943Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
PubMed 25581257Liu B, Liu X, Tang SJ. Interactions of Opioids and HIV Infection in the Pathogenesis of Chronic Pain. Front Microbiol. 2016 Feb 10;7:103. doi: 10.3389/fmicb.2016.00103. eCollection 2016.
PubMed 26903982Gandhi RT, McMahon DK, Bosch RJ, Lalama CM, Cyktor JC, Macatangay BJ, Rinaldo CR, Riddler SA, Hogg E, Godfrey C, Collier AC, Eron JJ, Mellors JW; ACTG A5321 Team. Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog. 2017 Apr 20;13(4):e1006285. doi: 10.1371/journal.ppat.1006285. eCollection 2017 Apr.
PubMed 28426825Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.
PubMed 26987082Vervest ACM, Schimmel GH. Taxonomy of pain of the IASP. Pain. 1988 Sep;34(3):318-321. doi: 10.1016/0304-3959(88)90129-7. No abstract available.
PubMed 3054730Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
PubMed 21704872Jiao JM, So E, Jebakumar J, George MC, Simpson DM, Robinson-Papp J. Chronic pain disorders in HIV primary care: clinical characteristics and association with healthcare utilization. Pain. 2016 Apr;157(4):931-937. doi: 10.1097/j.pain.0000000000000462.
PubMed 26683238Robinson-Papp J, Morgello S, Vaida F, Fitzsimons C, Simpson DM, Elliott KJ, Al-Lozi M, Gelman BB, Clifford D, Marra CM, McCutchan JA, Atkinson JH, Dworkin RH, Grant I, Ellis R. Association of self-reported painful symptoms with clinical and neurophysiologic signs in HIV-associated sensory neuropathy. Pain. 2010 Dec;151(3):732-736. doi: 10.1016/j.pain.2010.08.045. Epub 2010 Sep 20.
PubMed 20851521Morgello S, Estanislao L, Simpson D, Geraci A, DiRocco A, Gerits P, Ryan E, Yakoushina T, Khan S, Mahboob R, Naseer M, Dorfman D, Sharp V; Manhattan HIV Brain Bank. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol. 2004 Apr;61(4):546-51. doi: 10.1001/archneur.61.4.546.
PubMed 15096404Ellis RJ, Rosario D, Clifford DB, McArthur JC, Simpson D, Alexander T, Gelman BB, Vaida F, Collier A, Marra CM, Ances B, Atkinson JH, Dworkin RH, Morgello S, Grant I; CHARTER Study Group. Continued high prevalence and adverse clinical impact of human immunodeficiency virus-associated sensory neuropathy in the era of combination antiretroviral therapy: the CHARTER Study. Arch Neurol. 2010 May;67(5):552-8. doi: 10.1001/archneurol.2010.76.
PubMed 20457954Lehmann HC, Chen W, Borzan J, Mankowski JL, Hoke A. Mitochondrial dysfunction in distal axons contributes to human immunodeficiency virus sensory neuropathy. Ann Neurol. 2011 Jan;69(1):100-10. doi: 10.1002/ana.22150. Epub 2010 Nov 8.
PubMed 21280080
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV
- ClinicalTrials.gov ID
- NCT03692611
- Acronym / sponsor ID
- STOMP / STUDY19050051
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, HIV, Opioid prescribing, Behavioral clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Mental Health (NIMH), University of North Carolina, Chapel Hill
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.
Detailed description
Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose. In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible. The overall objective of this proposal is to evaluate a novel theory-based PSM intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PLWH. The investigators will accomplish the overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given the investigators' rigorous intervention development process and promising pilot trial results, the working hypothesis is that STOMP will decrease pain and improve function in PLWH. Investigators also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on the investigators' formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial to discover whether STOMP is an efficacious Pain Self-Management (PSM) intervention, mediated by the hypothesized Social Cognitive Theory (SCT) constructs.
| Arm | Type | Receives |
|---|---|---|
| Skills to Manage Pain (STOMP) | Experimental | Behavioral: Skills TO Manage Pain (STOMP)The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session. |
| comparison group | Active comparator | Behavioral: Comparison groupThe comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Enrolled in CNICS
- Age ≥ 18 years
- English-speaking
- Chronic pain (Brief Chronic Pain Screening Questionnaire (BCPQ) = at least moderate pain for at least 3 months)
- Moderately severe and impairing chronic pain (PEG pain questionnaire = average of all three items is 4 or greater)
Key exclusion criteria (5 listed)
- Do not speak or understand English
- Are planning a new pain treatment like surgery
- Cannot attend the group sessions
- Had previously participated in the pilot study (STOMP)
- Unwilling to provide informed consent
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 |
|---|---|---|
| Skills TO Manage Pain (STOMP)12 week pain self management (PSM) intervention incorporating social cognitive theory constructs. | Behavioural | Skills to Manage Pain (STOMP) |
| Comparison groupAlso: active comparatorParticipants in this arm will receive usual care as given by providers but no behavioral PSM intervention. | Behavioural | comparison group |
Primary outcome
Brief Pain Inventory (BPI) Total Score
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
The Brief Pain Inventory (BPI) is a validated tool measuring pain severity and its impact on daily functioning. It includes 11 items assessing pain severity (worst, least, average, current) and pain interference with general activity, mood, walking, work, relations with others, sleep, and enjoyment of life. Each item is rated from 0 (no pain/no interference) to 10 (worst pain imaginable/complete interference). The Pain Severity Subscore (0-10) is the average of four severity items, the Functional Interference Subscore (0-10) is the average of seven interference items, and the Total Score (0-10) is the average of all 11 items. Higher scores indicate worse pain severity and greater pain interference.
6 secondary outcomes
Brief Pain Inventory (BPI) Functional Interference Subscore
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
Brief Pain Inventory (BPI) Pain Severity Subscore
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
The Pain, Enjoyment and General Activity (PEG) Scale
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
The Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
The Patient Health Questionnaire-8 (PHQ-8)
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
The Pain Catastrophizing Scale (PCS)
Time frame: Immediately postintervention and 3-month follow-up (postintervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22766967Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215.
- Background: PubMed 28880698Merlin JS, Westfall AO, Johnson MO, Kerns RD, Bair MJ, Kertesz S, Turan JM, Clay OJ, Starrels JL, Kilgore M. Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH). J Med Econ. 2018 Feb;21(2):122-126. doi: 10.1080/13696998.2017.1377719. Epub 2017 Sep 18.
- Background: PubMed 24119077Merlin JS, Westfall AO, Chamot E, Overton ET, Willig JH, Ritchie C, Saag MS, Mugavero MJ. Pain is independently associated with impaired physical function in HIV-infected patients. Pain Med. 2013 Dec;14(12):1985-93. doi: 10.1111/pme.12255. Epub 2013 Oct 9.
- Background: PubMed 24809943Robinson-Papp J, Sharma S, Dhadwal N, Simpson DM, Morgello S. Optimizing measures of HIV-associated neuropathy. Muscle Nerve. 2015 Jan;51(1):56-64. doi: 10.1002/mus.24282. Epub 2014 Nov 21.
- Background: PubMed 25581257Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
- Background: PubMed 26903982Liu B, Liu X, Tang SJ. Interactions of Opioids and HIV Infection in the Pathogenesis of Chronic Pain. Front Microbiol. 2016 Feb 10;7:103. doi: 10.3389/fmicb.2016.00103. eCollection 2016.
- Background: PubMed 28426825Gandhi RT, McMahon DK, Bosch RJ, Lalama CM, Cyktor JC, Macatangay BJ, Rinaldo CR, Riddler SA, Hogg E, Godfrey C, Collier AC, Eron JJ, Mellors JW; ACTG A5321 Team. Levels of HIV-1 persistence on antiretroviral therapy are not associated with markers of inflammation or activation. PLoS Pathog. 2017 Apr 20;13(4):e1006285. doi: 10.1371/journal.ppat.1006285. eCollection 2017 Apr.
- Background: PubMed 26987082Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.
- Background: PubMed 3054730Vervest ACM, Schimmel GH. Taxonomy of pain of the IASP. Pain. 1988 Sep;34(3):318-321. doi: 10.1016/0304-3959(88)90129-7. No abstract available.
- Background: PubMed 21704872Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011 Jun 25;377(9784):2226-35. doi: 10.1016/S0140-6736(11)60402-9.
- Background: PubMed 26683238Jiao JM, So E, Jebakumar J, George MC, Simpson DM, Robinson-Papp J. Chronic pain disorders in HIV primary care: clinical characteristics and association with healthcare utilization. Pain. 2016 Apr;157(4):931-937. doi: 10.1097/j.pain.0000000000000462.
- Background: PubMed 20851521Robinson-Papp J, Morgello S, Vaida F, Fitzsimons C, Simpson DM, Elliott KJ, Al-Lozi M, Gelman BB, Clifford D, Marra CM, McCutchan JA, Atkinson JH, Dworkin RH, Grant I, Ellis R. Association of self-reported painful symptoms with clinical and neurophysiologic signs in HIV-associated sensory neuropathy. Pain. 2010 Dec;151(3):732-736. doi: 10.1016/j.pain.2010.08.045. Epub 2010 Sep 20.
- Individual participant dataSharing planned: No
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Jessica Merlin, MD PhD MBA principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills TO Manage Pain (STOMP) and Comparison group in people with Chronic Pain, run by University of Pittsburgh at 2 sites 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 7 inclusion and 5 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 19 Mar 2025). 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?
Brief Pain Inventory (BPI) Total Score (time frame: Immediately postintervention and 3-month follow-up (postintervention)). 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 NCT03692611, which also lists 93 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 19 Mar 2025.