Group-based Integrative Pain Management in Primary Care Safety Net Clinics

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06327542
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Group Acupuncture — OTHER
    Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
  • Integrative Group Medical Visits — OTHER
    IGMV sessions will be weekly for 90-120 minutes in a group meeting space. Sessions will start with a "check-in" where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice.

Study Details

Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. 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 ethnically diverse low-income patients.

Key Dates

Start date
Jul 12, 2024
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Care
    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.
  • Experimental: Group Acupuncture
    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.
  • Experimental: Integrative Group Medical Visits (IGMV)
    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.
  • Experimental: Group Acupuncture and IGMV
    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.

Primary Outcome Measure

Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function. [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tom Waddell Urban Health ClinicSan FranciscoCalifornia94102
Jesse Wennik, NP

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