Group-based Integrative Pain Management (IPMP+ Pilot)

NCT05906784 | Completed Results DMC

• 2 other identifiers: 22-370781R61MD018333
• Study Type: interventional
• Target: 44
• 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 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.

Conditions

Chronic Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Eligible Patients Who Are Randomized

  Percentage of patients with confirmed eligibility who are randomized

  Randomization

Secondary Outcomes (2)

• Percentage of Randomized Participants Who Complete the Study

  3-month follow up

• Intervention Adherence

  12 weeks

Other Outcomes (5)

• Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey

  3-month follow up

• Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey

  3-month follow up

• Social Support in Chronic Pain Scale

  3-month follow up

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.

group acupuncture

EXPERIMENTAL

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

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.

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 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.

Integrative Group Medical Visits (IGMV); group acupuncture and 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:

• current anticoagulant use
• 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

Location

Related Publications (1)

• Thompson-Lastad A, Wennik J, Swedlow P, Wu J, Hartogensis W, Jackson JLN, Chao MT. Group-Based Integrative Pain Management: Feasibility of a Factorial Randomized Trial in Safety-Net Primary Care. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251360113. doi: 10.1177/21501319251360113. Epub 2025 Aug 16.

  PMID: 40817732 DERIVED

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

Limitations and Caveats

Small pilot trial with a focus on feasibility for larger scale 2x2 factorial trial. Patient-reported outcomes were assessed as exploratory, not as confirmatory analysis.

Results Point of Contact

• Title: Maria Chao, DrPH, MPA, Principal Investigator
• Organization: University of California, San Francisco

Maria.Chao@ucsf.edu

415-353-7749

Study Officials

• Maria Chao, DrPH, MPA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: June 7, 2023
• First Posted: June 18, 2023
• Study Start: April 28, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

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

Locations

US (1)