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

70 Participants Needed

Trial Summary

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 data supports the effectiveness of the Integrative Medicine Group Visit treatment for chronic pain?

Research shows that Integrative Medicine Group Visits can help reduce chronic pain and depression by teaching patients new ways to manage their pain, like mindfulness and movement, which can lead to less reliance on medication and improved mental health. ^{1 2 3 4 5}

Is Integrative Medicine Group Visits (IMGV) safe for humans?

The research does not specifically mention any safety concerns related to Integrative Medicine Group Visits (IMGV) for chronic pain, suggesting it is generally considered safe. However, it is always important to discuss any new treatment with your healthcare provider. ^{1 6 7 8 9}

How is the Integrative Medicine Group Visit treatment different from other treatments for chronic pain?

The Integrative Medicine Group Visit (IMGV) is unique because it combines mindfulness techniques, evidence-based integrative medicine, and group medical visits, offering a non-drug approach to managing chronic pain. This treatment is particularly beneficial for diverse, underserved populations who may have limited access to non-pharmacological therapies. ^{2 3 5 8 10}

What is the purpose of this trial?

Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.

Research Team

Isabel J Roth, DrPH, MS

Principal Investigator

University of North Carolina at Chapel Hill School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Integrative medicine for chronic pain: A cohort study using a process-outcome design in the context of a department for internal and integrative medicine. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

Living with chronic pain: Evaluating patient experiences with a medical group visit focused on mindfulness and non-pharmacological strategies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Vulnerable Patients' Psychosocial Experiences in a Group-Based, Integrative Pain Management Program. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Latino Integrative Medical Group Visit as a Model for Pain Reduction in Underserved Spanish Speakers. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Listening to Their Words: A Qualitative Analysis of Integrative Medicine Group Visits in an Urban Underserved Medical Setting. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A descriptive analysis of an integrative medicine clinic. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of integrative medicine group visits in chronic pain and depressive symptoms: A randomized controlled trial. [2023]

9. Switzerland 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Depression Predicts Chronic Pain Interference in Racially Diverse, Income-Disadvantaged Patients. [2022]