Group-based Integrative Pain Management (IPMP+ Pilot)

Not Applicable

Completed

Conditions: Chronic Pain

Interventions: Other: group acupuncture
Other: Integrative Group Medical Visits

Registration Number: NCT05906784

Lead Sponsor: University of California, San Francisco

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 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.

Detailed 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/).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
group acupuncture and IGMV	Integrative Group Medical Visits	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 acupuncture	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.
Integrative Group Medical Visits (IGMV)	Integrative Group Medical Visits	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 acupuncture and IGMV	group acupuncture	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 Measures

Name	Time	Method
Percentage of Eligible Patients Who Are Randomized	Randomization	Percentage of patients with confirmed eligibility who are randomized

Secondary Outcome Measures

Name	Time	Method
Percentage of Randomized Participants Who Complete the Study	3-month follow up	Retention as percentage of randomized who complete 3-month follow up survey
Intervention Adherence	12 weeks	average number of intervention sessions attended