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

NCT06327542 | Recruiting DMC

• 2 other identifiers: 22-37078B4R33MD018333
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

health equity; integrative health; nonpharmacologic pain management; stigma; social isolation; primary care; group medical visits

Outcome Measures

Primary Outcomes (2)

• Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function.

  Self-reported pain impact will be measured as a composite score of pain intensity, pain interference and physical function. These scores are summed to create Pain Impact, which ranges from 3-50, with higher scores indicating greater impact of pain on one's life, capturing overall day-to-day physical function, the impact of pain on ability to do regular life tasks, and the intensity of pain experienced.

  Baseline, 12 weeks, and 24 weeks

• Change in Social support and Pain Questionnaire (SPQ)

  Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social support and Pain Questionnaire (SPQ). Total scores range from 0 to 24, with higher scores indicating greater levels of social support.

  Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (12)

• Change in average pain intensity on the 0-10 numeric rating scale

  Baseline, 12 weeks, and 24 weeks

• Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference.

  Baseline, 12 weeks, and 24 weeks

• Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b

  Baseline, 12 weeks, and 24 weeks

• Change in Internalized Stigma of Chronic Pain (ISCP) survey

  Baseline, 12 weeks, and 24 weeks

• Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a

  Baseline, 12 weeks, and 24 weeks

Study Arms (4)

Usual Care

NO 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

EXPERIMENTAL

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.

Other: Group Acupuncture

Integrative Group Medical Visits (IGMV)

EXPERIMENTAL

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.

Other: Integrative Group Medical Visits

Group Acupuncture and IGMV

EXPERIMENTAL

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.

Other: Group Acupuncture; Other: Integrative Group Medical Visits

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.

Group Acupuncture; Group Acupuncture and IGMV

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.

Group Acupuncture and IGMV; Integrative Group Medical Visits (IGMV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥ 18
• Fluency in English or Spanish
• Panelled to a primary care provider at one of the study clinics
• Diagnosis of chronic pain (\> 3 months)
• Had a primary care visit for chronic pain within the past six months
• Ability to provide a phone number
• Able to participate in groups
• Intent to be available for up to 24 weeks

You may not qualify if:

• Received group-based pain management in the past 3 months
• Received acupuncture treatment for pain in the past 3 months
• Active cancer treatment
• Inability to provide informed consent due to mental illness or cognitive impairment

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Tom Waddell Urban Health Clinic

San Francisco, California, 94102, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Social Stigma; Social Isolation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Maria Chao, DrPH, MPA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Wu, MPH

CONTACT

415-502-8733; Julia.Wu@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial trial

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: July 12, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: To be determined based on NIH HEAL policies
• Access Criteria: Access to trial IPD can be requested by qualified researchers, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement.

Locations

US (1)