Peer Support Pain Self-Management for Musculoskeletal Pain

(CONNECT Trial)

Overseen By Kimberly L Selander, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Life-threatening conditions, Sensory deficits, Surgery, Mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based program called Project CONNECT, designed to help women Veterans manage chronic musculoskeletal pain. Participants will pair up to exchange support, learn pain coping skills, set activity goals, and follow a walking program. The trial seeks women Veterans who have experienced moderate to severe pain for at least six months and are receiving care at specific VA healthcare systems. Participants need a cell phone to communicate regularly with their peer partner. The focus is on making pain management more accessible and supportive. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative pain management solutions tailored for women Veterans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this peer support pain self-management intervention is safe for women Veterans with chronic musculoskeletal pain?

Research has shown that self-management programs for musculoskeletal pain, such as Project CONNECT, can lead to small but meaningful improvements in pain and overall health. These programs are generally easy to manage because they don't involve medication or medical procedures. Participants learn skills to cope with pain and support each other, aiding in effective pain management.

Since this trial is in the "not applicable" phase, it does not test a new drug or device. Instead, it focuses on improving pain management through peer support. This approach presents minimal safety concerns, as it is non-invasive and involves communication and goal-setting.

Overall, Project CONNECT appears to be a safe option for those interested in managing chronic pain through peer support and self-management techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project CONNECT because it offers a fresh approach to managing chronic musculoskeletal pain through peer support. Unlike standard treatments that often rely on medications like NSAIDs or physical therapy, this program emphasizes an 8-week home-based reciprocal peer support system. This method not only empowers individuals to manage their pain more effectively but also fosters a community of support, potentially enhancing both mental and physical well-being. By focusing on self-management and peer interaction, Project CONNECT could revolutionize how chronic pain is addressed, making it more sustainable and personalized.

What evidence suggests that Project CONNECT is effective for managing chronic musculoskeletal pain?

Research has shown that digital health programs can reduce pain and improve movement for individuals with muscle and joint pain. One study found that these programs help people manage pain more effectively and enhance their physical abilities over time. Participants in that study performed their exercises at home more consistently, leading to improved physical therapy outcomes. This trial will evaluate Project CONNECT, an 8-week home-based reciprocal peer support pain self-management program, to determine if it helps individuals adhere to their pain management plans, significantly impacting chronic pain management. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary Driscoll, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Are You a Good Fit for This Trial?

This trial is for women veterans with moderate to severe musculoskeletal pain, who have experienced pain on most days in the past six months. Participants must be receiving care at specified VA healthcare systems, own a cell phone, and be cleared by their provider. Those with life-threatening conditions, sensory deficits affecting calls, upcoming surgeries or certain mental health conditions cannot join.

Inclusion Criteria

I have experienced pain on most days in the last six months.

I have a cell phone I can use freely and am willing to regularly text or call a peer partner.

The study is open to female veterans receiving care at the VA Connecticut Healthcare System or VA Central Western Massachusetts.

Exclusion Criteria

I am scheduled for or have recently had surgery.

You have a mental health condition that would make it hard for you to take part in treatment or be a good peer.

I do not have hearing or speaking issues that would prevent me from participating in phone calls.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (telephone-based)

Behavioral Run-in

Participants undergo a 1-week behavioral run-in period to mimic demands of the intervention

1 week

1 visit (telephone-based)

Treatment

Participants engage in an 8-week home-based reciprocal peer support pain self-management intervention

8 weeks

Weekly phone calls and nightly text messages

Follow-up

Participants are monitored for retention and effectiveness post-treatment

3 months

Assessments at 10 and 22 weeks post-intervention start

Long-term Follow-up

Long-term follow-up to assess retention and responder analysis

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Project CONNECT

Trial Overview Project CONNECT is being tested; it's an 8-week home-based program where paired participants support each other through text messages and weekly calls to manage chronic pain using coping skills, activity goals setting, and a walking program. All eligible women will receive this intervention without comparison groups.

How Is the Trial Designed?

Group I: Pilot Arm: Project CONNECT Experimental Treatment 1 Intervention

8-week home based reciprocal peer support pain self-management program for chronic musculoskeletal pain

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Connecticut Healthcare System

Collaborator

Trials

86

Recruited

8,800+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

A qualitative study involving 18 patients with chronic musculoskeletal pain and depression identified key barriers to self-management, including lack of support, limited resources, and ineffective pain-relief strategies.

Facilitators for better self-management included encouragement from healthcare providers, improved depression treatment, and having a variety of self-management strategies to choose from.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to chronic pain self-management: a qualitative study of primary care patients with comorbid musculoskeletal pain and depression. Bair, MJ., Matthias, MS., Nyland, KA., et al.[2022]

A pilot study involving 20 male veterans with chronic musculoskeletal pain tested a peer support intervention, where peer coaches guided patients in pain self-management strategies over 4 months.

While the primary outcome of pain improvement did not reach statistical significance, secondary outcomes like self-efficacy and pain centrality showed moderate improvements, suggesting that peer-delivered strategies may be beneficial for veterans managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness. Matthias, MS., McGuire, AB., Kukla, M., et al.[2022]

A 7-week self-management program for chronic musculoskeletal pain was attended by 376 out of 528 recruited patients, showing a high uptake rate of 71% and an 82% completion rate among those who participated.

Participants experienced significant improvements in patient activation, health status, and reductions in depression, anxiety, and pain severity, indicating the program's efficacy in enhancing self-management skills for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of uptake and effect on patient-reported outcomes of a clinician and patient co-led chronic musculoskeletal pain self-management programme provided by the UK National Health Service. Anderson, JK., Wallace, LM.[2020]

Veterans participating in a peer support intervention for chronic pain found it beneficial to connect with fellow veterans and peer coaches who also experience chronic pain, which enhanced their engagement in the program.

However, logistical challenges and issues with motivation were significant barriers to participation, highlighting the need for strategies to address these obstacles in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and Barriers to Participation in a Peer Support Intervention for Veterans With Chronic Pain. Matthias, MS., Kukla, M., McGuire, AB., et al.[2019]

The peer support intervention (PALS) was found to be feasible and acceptable for older adults (ages 65-79) with Chronic Low Back Pain (CLBP), with two-thirds of participants retained throughout the study.

Participants expressed high satisfaction with PALS and indicated they would recommend it to others, suggesting that the intervention could be a valuable resource for self-management in CLBP, although recruitment methods need refinement for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PALS: peer support for community dwelling older people with chronic low back pain: a feasibility and acceptability study. Cooper, K., Schofield, P., Smith, BH., et al.[2021]

In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, indicating its potential effectiveness in managing chronic pain alongside standard care.

Approximately 73.6% of participants agreed to use the app, and those who engaged with it reported significant improvements in mental health outcomes, suggesting that digital tools can enhance patient self-management in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. Bhatia, A., Kara, J., Janmohamed, T., et al.[2021]

Self-management (SM) support for musculoskeletal pain (MSKP) is a promising but underutilized strategy that can help individuals manage their symptoms effectively and improve their quality of life, although past studies have shown mixed outcomes.

Recent positive results in SM for MSKP suggest that incorporating psychosocial skills and contemporary pain neuroscience into treatment can enhance engagement and effectiveness, highlighting the need for therapists to improve their communication and understanding of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy support for self-management of persisting musculoskeletal pain disorders. Diener, I.[2022]

Self-management interventions for chronic musculoskeletal pain show that baseline factors like self-efficacy and depression significantly predict treatment outcomes, while pain catastrophizing and physical activity can mediate these outcomes.

Despite the good methodological quality of the studies reviewed, there is insufficient evidence on which baseline factors moderate the effectiveness of self-management treatments, indicating a need for future research with stronger designs and larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we identify how programmes aimed at promoting self-management in musculoskeletal pain work and who benefits? A systematic review of sub-group analysis within RCTs. Miles, CL., Pincus, T., Carnes, D., et al.[2022]

A randomized controlled trial involving 215 veterans with chronic musculoskeletal pain tested a peer coach-delivered pain self-management program, but adherence to the program was low, with only 13% of patients attending the recommended number of meetings.

Both the peer support and control groups showed a decrease in total pain over 9 months, but there was no significant difference in pain reduction or other secondary outcomes between the two groups, suggesting that the peer support model may need to be revised for better effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. Matthias, MS., Bair, MJ., Ofner, S., et al.[2021]

A redesigned, shorter self-management education program for musculoskeletal conditions led to small but statistically significant improvements in pain, health distress, and self-efficacy among participants, based on a study with a 47% response rate (n=102).

The program, which incorporates motivational interviewing and adult learning principles, highlights the importance of community-based education in managing chronic musculoskeletal conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Take Charge of Pain: evaluating a community-targeted self-management education program for people with musculoskeletal pain. Hoon, E., Smith, K., Black, J., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9778537/

Long-Term Clinical Outcomes of a Remote Digital ... This study suggests that a digital CMP program may have a lasting impact on improved pain and functionality in patients with CMP.

2. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141707413

CDA 18-005 – HSR Study - VA Health Systems Research Targeting Barriers to Pain Self-Management in Women Veterans: Refinement and Feasibility of a Novel Peer Support Intervention (Project CONNECT)

3. digital.ahrq.gov digital.ahrq.gov/medical-condition/chronic-pain

Chronic Pain | Digital Healthcare Research This research examines whether remote therapeutic monitoring can improve physical therapy outcomes by increasing patient engagement, adherence to home exercises ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06058624/assessing-the-efficacy-of-an-acceptance-based-digital-intervention-for-veterans-with-chronic-pain

Assessing the Efficacy of an Acceptance-Based Digital ... Pain has been identified as among the most frequent presenting medical complaints, in particular within primary care for Veterans.

5. jmir.org jmir.org/2022/9/e37869/

Digital Health Interventions for Musculoskeletal Pain ... Moderate-quality evidence supports the conclusion that digital health interventions are effective in reducing pain and improving functioning and self- ...

6. hsrd.research.va.gov hsrd.research.va.gov/impacts/mbi-pain.cfm

Telehealth Mindfulness-Based Interventions (MBIs) for ... Two versions of a telehealth mindfulness-based intervention (MBI) are each more effective than usual care in relieving chronic pain.

7. withpower.com withpower.com/trial/phase-musculoskeletal-pain-4-2021-9c609

Peer Support Pain Self-Management for Musculoskeletal Pain ... Research shows that self-management programs for musculoskeletal pain, like Project CONNECT, can lead to small but significant improvements in pain, health ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12484128/

Effectiveness of digital pain management for older adults ... We collected outcome data immediately after treatment (baseline), 6-month follow-up (6 months), and 12-month follow-up. The type of studies included were ...

9. go.drugbank.com go.drugbank.com/conditions/DBCOND0032136

Musculoskeletal Pain (DBCOND0032136) Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT), No drug interventions, treatment, Not Available, completed. NCT04196634. Risk ...