Integrative Medicine Group Visits for Chronic Pain

(MAGIC Trial)

Overseen By Jennifer Leeman, DrPH, MDiv

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Not in IMGV program, others

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

Compensation: Varies

Number of Visits: 1

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the implementation and use of integrative medicine group visits (IMGV) in community health centers to assist individuals with chronic pain. The goal is to make these non-drug pain management therapies, often not covered by insurance, more accessible to low-income individuals. The trial involves training clinic staff to conduct these group visits and measuring their impact on patients' health outcomes. Individuals with chronic pain who are already enrolled in the IMGV program at their community health center may be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to expand access to effective pain management.

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's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that the Integrative Medicine Group Visit is safe for patients with chronic pain?

Research shows that integrative medicine group visits (IMGV) are generally safe and well-tolerated for people with chronic pain. Studies have found that participants often experience better mental health and an improved quality of life, without significant side effects. For example, one study found that patients had better mental health and needed less expensive medical care after joining the IMGV program.

Studies have reported no serious safety issues in integrative medicine group visits, suggesting that this treatment is safe for most people. Although research in Federally-Qualified Health Centers (FQHCs) is limited, available data supports the safety of these group visits for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic pain, which often rely on medications like opioids or NSAIDs, Integrative Medicine Group Visits (IMGV) offer a holistic approach by combining group therapy with integrative medicine practices. This method emphasizes the power of community support and combines multiple healing practices, such as mindfulness, yoga, and acupuncture, which are not typically part of traditional pain management. Researchers are excited about IMGV because it has the potential to address not just the physical symptoms but also the emotional and social aspects of chronic pain, offering a more comprehensive and personalized approach to care.

What evidence suggests that the Integrative Medicine Group Visit is effective for chronic pain?

Research shows that Integrative Medicine Group Visits (IMGV), which participants in this trial will receive, can help people with chronic pain. Studies have found that those who participate in IMGV often use less pain medication. For example, one study found that participants were less than half as likely to use pain medication after 21 weeks compared to those who didn't join IMGV. Another study showed that IMGV also led to better mental health and quality of life. These findings suggest that IMGV can help manage chronic pain and improve overall well-being. ^{4 6 7 8 9}

Who Is on the Research Team?

Isabel J Roth, DrPH, MS

Principal Investigator

University of North Carolina at Chapel Hill School of Medicine

Are You a Good Fit for This Trial?

The MAGIC Study is for adults with chronic pain, particularly those from lower-income backgrounds who have limited access to integrative pain management therapies. It's designed to help them through a program that health insurance can cover. The trial seems open to a broad range of participants as specific inclusion and exclusion criteria are not detailed.

Inclusion Criteria

Staff and clinicians at each clinic who are involved in implementation of the IMGV

Patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center

Exclusion Criteria

I am not involved in the IMGV at the specific clinical sites.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation and Training

Clinic personnel receive training and coaching for delivering integrative medicine group visits (IMGV), and patients participate in orientation

2 weeks

1 visit (in-person)

Treatment

Participants engage in the 9-week Integrative Medical Group Visit (IMGV) program

9 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for health outcomes and effectiveness of the IMGV program

12 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Strategies
• Integrative Medicine Group Visit

Trial Overview This study tests the Integrative Medical Group Visit (IMGV) program in Federally-Qualified Health Centers (FQHCs). It involves group care sessions that introduce patients to non-drug treatments for chronic pain, supported by training clinic staff. The effectiveness on mental health and healthcare usage will be measured.

How Is the Trial Designed?

Group I: Training, Coaching, and Orientation Experimental Treatment 2 Interventions

Clinic personnel will receive training for delivering integrative medicine group visits (IMGV) and ongoing coaching in delivering IMGV for patients with chronic pain. Clinic patients will participate in orientation and the 9-week IMGV.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

The study found a predictive relationship between depression and chronic pain interference in a randomized clinical trial involving diverse, income-disadvantaged patients, highlighting the importance of addressing mental health in pain management.

Key mediators identified, such as high perceived stress, low pain self-efficacy, and poor sleep quality, suggest potential targets for improving treatment outcomes in patients suffering from both chronic pain and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. Nephew, BC., Incollingo Rodriguez, AC., Melican, V., et al.[2022]

The Integrative Pain Management Program (IPMP), a 12-week multimodal approach, helped 41 low-income patients with chronic pain develop new strategies for pain management, leading to reduced medication use and increased psychological resilience.

Participants reported feeling more hopeful and socially connected after completing the program, highlighting the effectiveness of addressing psychosocial factors in chronic pain management within primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vulnerable Patients' Psychosocial Experiences in a Group-Based, Integrative Pain Management Program. Bruns, EB., Befus, D., Wismer, B., et al.[2023]

The Integrative Medical Group Visit (IMGV) approach for chronic pain management was found to be feasible and acceptable, with 12 out of 16 enrolled patients completing at least two sessions, highlighting its potential as a non-pharmacological intervention.

While no statistically significant improvements were observed in most health outcome measures, qualitative feedback indicated that participants gained valuable self-care skills and social support, suggesting that IMGV may enhance coping strategies for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative medical group visits for patients with chronic pain: results of a pilot single-site hybrid implementation-effectiveness feasibility study. Roth, I., Tiedt, M., Miller, V., et al.[2023]

A pilot study involving 19 Spanish-speaking Latino patients with chronic pain demonstrated that an adapted Integrative Medical Group Visit (IMGV) curriculum significantly reduced pain interference, fatigue, and depression, indicating its efficacy as a nonpharmacological treatment option.

Participants reported positive experiences and benefits from the program, highlighting the importance of providing care in Spanish, which may help address healthcare disparities in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Latino Integrative Medical Group Visit as a Model for Pain Reduction in Underserved Spanish Speakers. Cornelio-Flores, O., Lestoquoy, AS., Abdallah, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10565345/

Integrative medical group visits for patients with chronic pain These data provide evidence in support of the effectiveness of IMGV among participants who receive the intervention. Further study of the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31851666/

Effectiveness of integrative medicine group visits in chronic ... Objective: Determine the effectiveness of IMGV compared to a Primary Care Provider (PCP) visit in patients with chronic pain and depression.

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0225540

Effectiveness of integrative medicine group visits in chronic ... At 21 weeks, the IMGV group reported reduction in pain medication use (Odds Ratio: 0.42, CI: 0.18–0.98) compared to controls. Limitations.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02262377

Integrative Medicine Group Visits: A Patient-Centered ... The purpose of this study is to determine whether Integrative Medicine Group Visits (IMGV) are effective for treating patients with chronic pain and depression.

5. pcori.org pcori.org/research-results/2013/do-group-medical-visits-focus-mind-and-body-help-patients-chronic-pain-and-symptoms-depression

Do Group Medical Visits with a Focus on Mind and Body ... In this study, the research team wanted to know if a group medical visit program with a focus on mind and body care would help patients with chronic pain and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6919581/

Effectiveness of integrative medicine group visits in chronic ... Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory).

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027795362030280X

Chronic pain management in integrative group medical visits Integrative group medical visits include complementary and integrative care and peer support. Existing health care policy limits access to pain management.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06327542

Group-based Integrative Pain Management in Primary ... The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12358000/

Group-Based Integrative Pain Management: Feasibility of a ... This pilot study tested the feasibility and acceptability of a pragmatic randomized trial evaluating group-based non-pharmacologic ...