Integrative Pain Management for Chronic Pain

(IPMP+ Trial)

Overseen By Julia Wu, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Active cancer treatment, mental illness, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new ways to manage chronic pain in low-income, racially, and ethnically diverse individuals. Researchers are testing two main treatments: group acupuncture, which uses needles to stimulate specific points on the body, and integrative group medical visits that include education on pain, physical movement, mindfulness training, and peer support. The goal is to find more effective, non-drug methods to help those who feel isolated and face challenges in pain care. Individuals with chronic pain for more than three months, who have recently seen a primary care doctor for their pain, and can join group sessions might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions.

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 the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both group acupuncture and integrative group medical visits (IGMV) are generally well-tolerated by patients. Group acupuncture effectively reduces pain and improves physical function without serious side effects. Patients often feel relaxed after treatments, and side effects, such as minor bruising, are rare.

IGMV combines education and support with various non-drug therapies. Participants learn to manage pain through lifestyle changes and receive support from others with similar experiences. Studies suggest this method is safe and helps improve pain management without significant negative effects.

Overall, both treatments have shown promise in improving pain and are considered safe based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic pain because they incorporate holistic approaches that go beyond typical pain management strategies like medication and physical therapy. Group Acupuncture offers tailored acupuncture sessions in a community setting, which may enhance both physical and emotional well-being through social support and traditional Chinese medicine techniques. Integrative Group Medical Visits (IGMV) take a comprehensive approach by combining education on pain management, mindfulness, and peer support, all within a structured 12-week program. This combination not only addresses physical symptoms but also targets mental and social aspects of chronic pain, aiming to provide a more rounded and sustainable relief option compared to standard care.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that integrative group medical visits (IGMV), one of the treatments in this trial, can help manage chronic pain. One study found that these visits reduced the need for pain medication and improved overall well-being. Participants in IGMV reported better physical and mental health, experiencing less pain and improved social interactions.

For group acupuncture, another treatment option in this trial, studies indicate it can greatly reduce pain and enhance physical abilities. After three months of group acupuncture, about 30% of participants reported a significant decrease in how much pain affected their daily lives. Both treatments offer promising options for managing chronic pain, and this trial will evaluate their effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Maria Chao, DrPH, MPA

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals from low-income backgrounds who are experiencing chronic pain and receive care at primary safety net clinics. It aims to help those affected by social isolation, stigma, and disparities in pain management.

Inclusion Criteria

Intent to be available for up to 24 weeks

I can provide a contact phone number.

I visited my doctor for chronic pain in the last 6 months.

Exclusion Criteria

I have participated in a group pain management program recently.

I am able to understand and consent to my medical treatment.

I have had acupuncture for pain within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Integrative Group Medical Visits (IGMV), group acupuncture, both, or usual care for 12 weeks

12 weeks

Weekly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

Final Follow-up

Final assessment of outcomes including pain impact and social support

6 months after baseline

What Are the Treatments Tested in This Trial?

Interventions

• Group Acupuncture
• Integrative Group Medical Visits

Trial Overview The study is testing two group-based treatments: acupuncture and integrative group medical visits. These approaches are designed to address chronic pain using a comprehensive model that considers biological, psychological, and social factors.

How Is the Trial Designed?

Group I: Integrative Group Medical Visits (IGMV) Experimental Treatment 1 Intervention

IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials.

Group II: Group Acupuncture and IGMV Experimental Treatment 2 Interventions

Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above.

Group III: Group Acupuncture Experimental Treatment 1 Intervention

Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records.

Group IV: Usual Care Active Control 1 Intervention

Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit.

Group Acupuncture is already approved in United States, European Union, China, Canada for the following indications:

Approved in United States as Acupuncture for:

• Chronic Pain Management
• Pain Relief

Approved in European Union as Acupuncture Therapy for:

• Pain Management
• Migraines
• Tension Headaches

Approved in China as Traditional Chinese Medicine Acupuncture for:

• Chronic Pain
• Neck Pain
• Back Pain
• Migraines

Approved in Canada as Acupuncture Treatment for:

• Pain Relief
• Chronic Pain Management
• Migraines

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A retrospective study of 218 chronic pain patients showed that a comprehensive interdisciplinary pain management program led to significant improvements in physical and mental health, with 77% of participants reporting substantial improvement immediately after the program and 76% at 12 months post-discharge.

The program also positively impacted social health outcomes, with notable increases in employment and educational levels among participants, particularly those previously on disability or part-time work.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term outcomes of chronic pain patients attending a publicly funded community-based interdisciplinary pain program in the Greater Toronto area: results of a practice-based audit. Mailis, A., Deshpande, A., Lakha, SF.[2022]

Interdisciplinary chronic pain management programs, which incorporate the biopsychosocial model of pain, have been shown to be more therapeutically effective and cost-effective compared to traditional medical interventions.

Despite their effectiveness, there are significant barriers to the wider implementation of these interdisciplinary programs, highlighting the need for future efforts to promote their use in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary chronic pain management: past, present, and future. Gatchel, RJ., McGeary, DD., McGeary, CA., et al.[2022]

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]

Among Veterans who received Battlefield Acupuncture (BFA), 9.5% went on to use traditional acupuncture, compared to only 0.9% of those who did not receive BFA, indicating a significant increase in subsequent acupuncture use.

Veterans who used BFA had 10.9 times greater odds of trying traditional acupuncture afterward, suggesting that BFA not only provides immediate pain relief but also encourages patients to explore further nonpharmacologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Offering Battlefield Acupuncture Lead to Subsequent Use of Traditional Acupuncture? Thomas, ER., Zeliadt, SB., Coggeshall, S., et al.[2023]

Chronic pain management requires an interdisciplinary approach that considers biological, cognitive, emotional, behavioral, and social factors, rather than just focusing on physical symptoms.

Recent clinical studies show that interdisciplinary pain management programs are effective and cost-efficient, highlighting the importance of addressing the complex nature of chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interdisciplinary treatment of chronic pain. Gardea, MA., Gatchel, RJ.[2019]

The AADDOPT-2 study compared individual and group acupuncture for chronic pain in a diverse urban population, finding that both methods provided significant pain relief and improved quality of life for patients.

While some patients had initial concerns about privacy in group settings, most reported that these concerns diminished after starting treatment, indicating that group acupuncture can be an effective and acceptable alternative to individual sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's Better in a Group Anyway": Patient Experiences of Group and Individual Acupuncture. Chuang, E., Hashai, N., Buonora, M., et al.[2023]

A review of 468 reported incidents related to acupuncture treatments in NHS organizations identified 325 cases that met the criteria for analysis, revealing that while adverse events (AEs) like retained needles (31%) and dizziness (30%) were common, 95% of these incidents were categorized as low or no harm.

Despite the majority of reported AEs being mild, the study highlights the importance of awareness and preparedness among acupuncture practitioners to manage potential serious complications, as miscategorization and under-reporting could affect the understanding of acupuncture's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety incidents from acupuncture treatments: a review of reports to the National Patient Safety Agency. Wheway, J., Agbabiaka, TB., Ernst, E.[2016]

Acupuncture is recommended by various international clinical guidelines as an effective option for managing chronic pain, placing it on par with conventional treatments.

This article emphasizes that acupuncture should be considered early in the treatment process for chronic pain, rather than as a last resort, and provides guidance for primary care physicians on how to refer patients for acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acupuncture and chronic pain : practical considerations for primary care physicians]. Zurron, N., Lanier, C., Berna-Renella, C.[2020]

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 Pain & Wellness Centre (PWC) in Vaughan, Ontario, successfully implemented a publicly funded interdisciplinary pain management program, serving over 1,000 new patients and demonstrating significant improvements in patient outcomes after 3 months.

This model of care, based on the biopsychosocial approach, showcases the feasibility of providing effective chronic pain management in community settings, aligning with the Ontario Ministry of Health's comprehensive pain strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From (Ontario Ministry of Health and Long-Term Care) policy to implementation: A retrospective look at a community-based patient-centered model of care for chronic pain. Mailis, A., Lakha, SF.[2022]

A review of 57 systematic reviews found that while acupuncture is commonly used for pain control, there is little convincing evidence of its effectiveness, with unanimous positive results only for neck pain.

The review also reported 95 cases of serious adverse effects, including 5 fatalities, highlighting safety concerns associated with acupuncture, particularly risks of pneumothorax and infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture: does it alleviate pain and are there serious risks? A review of reviews. Ernst, E., Lee, MS., Choi, TY.[2022]

Citations

1. academic.oup.com academic.oup.com/painmedicine/article/19/2/393/3865379

Acupuncture Therapy in a Group Setting for Chronic Pain Acupuncture therapy offered in the group setting was effective in reducing pain severity, pain interference, and depression in patients with chronic neck, back ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32076985/

Individual vs. Group Delivery of Acupuncture Therapy for ... Key results: 37.5% of individual arm and 30.3% in group had > 30% improvement in pain interference (d = 7.2%, 95% CI - 0.6%, 15.1%). Non- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7174252/

Individual vs. Group Delivery of Acupuncture Therapy for ... Both individual and group acupuncture therapy delivered in primary care settings reduced chronic pain and improved physical function at 12 weeks.

4. pcori.org pcori.org/research-results/2014/comparing-group-and-individual-acupuncture-therapy-treating-chronic-pain-among-ethnically-diverse-patients-low-incomes-aaddopt-2

Comparing Group and Individual Acupuncture Therapy for ... Three months after treatment ended, 30 percent of patients who had group acupuncture sessions reported large decreases in how much pain disrupted their daily ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1357513

Acupuncture for Chronic Pain: Individual Patient Data Meta ... We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06327542

Group-based Integrative Pain Management in Primary ... The investigators will test the hypotheses that compared with usual care, group acupuncture and IGMV improve pain outcomes among racially and ethnically diverse ...

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

Group-Based Integrative Pain Management: Feasibility of a ... This study tests the hypotheses that assignment to group acupuncture or IGMV will improve pain outcomes and social support in participants with ...