Group-based Integrative Pain Management (IPMP+ Pilot)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Chronic Pain

Treatments: Other: group acupuncture; Other: Integrative Group Medical Visits

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05906784

1R61MD018333 (U.S. NIH Grant/Contract)

22-37078

Details and patient eligibility

About

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 pilot 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.

Full description

Background: The proposed pilot study seeks to address chronic pain disparities in racially diverse, socioeconomically disadvantaged individuals by optimizing multimodal pain management provided in primary care safety net clinics. Multilevel barriers exist in primary care settings where socioeconomically disadvantaged patients are most often treated. Lack of access to multimodal and nonpharmacologic care at the organizational level alongside provider bias and other forms of discrimination at the interpersonal level contribute to unequal assessment, treatment, and quality of pain care. Stigmatization cross-cuts all levels and is closely linked with social isolation common among individuals with chronic pain. Group-based models are a promising multilevel approach to increase access to non-pharmacologic therapies, address time constraints that contribute to disparities in pain care, improve patient-clinician communication, and provide social support among safety net patients with chronic pain.

Methods: This pilot study uses mixed methods and a pragmatic 2x2 randomized factorial trial to test two group-based models: integrative group medical visits (IGMV) and group acupuncture. Study interventions include 12 weekly sessions based on existing protocols tested in primary care safety net settings. IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. During this pilot study, a panel of national experts and patient stakeholders will refine and optimize the structure, process, and content of IGMV aimed at reducing social isolation and intersectional stigma as part of pain management. Interventions will be piloted in 40 English or Spanish speaking patients with chronic pain at two primary care safety net clinics. Study procedures will be tested and adapted for a larger scale trial. The larger study will test the hypotheses that compared with usual care, each study intervention improves pain interference and social isolation (primary outcomes), and that the two combined have synergistic effects mediated by increased social support and decreased impact of intersectional stigma among safety net patients with chronic pain.

Significance: Multilevel approaches are needed to advance health equity in pain management. The proposed study will contribute to knowledge of group-based integrative pain management co-located in primary care to address disparities in pain care for socioeconomically vulnerable populations. The study receives support from the Helping to End Addiction Long-term® (HEAL) Initiative (https://heal.nih.gov/).

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• current anticoagulant use
• active cancer treatment
• inability to provide informed consent due to mental illness or cognitive impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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44 participants in 4 patient groups

usual care

No Intervention group

Description:

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.

group acupuncture

Experimental group

Description:

Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting.

Treatment:

Other: group acupuncture

Integrative Group Medical Visits (IGMV)

Experimental group

Description:

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.

Treatment:

Other: Integrative Group Medical Visits

group acupuncture and IGMV

Experimental group

Description:

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.

Treatment:

Other: Integrative Group Medical Visits

Other: group acupuncture