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

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Other: Integrative Group Medical Visits; Other: Group Acupuncture

• Registration Number: NCT06327542
• 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 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 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 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. In collaboration with primary care safety net clinics, the investigators will recruit and randomize 360 participants to (1) IGMV, (2) group acupuncture, (3) both, or (4) neither (usual care, waitlist control). IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Participants randomized to IGMV will initiate groups once enough participants for a cohort have enrolled (8-12 patients). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. Participants randomized to group acupuncture will initiate 12 weeks of treatment once baseline is completed. Study participants will be asked to complete a total of 3 assessments: a pre-test (baseline), post-test at 3-months, and final follow-up 6 months after baseline.

The investigators will test the hypotheses that compared with usual care, group acupuncture and IGMV improve pain outcomes among racially and ethnically diverse, low-income patients with chronic pain. Our co-primary outcomes of interest are changes in pain impact from baseline to three months (a composite score of pain intensity, pain interference, and physical function) and social support in chronic pain.

Secondary outcomes include: pain interference, pain intensity, physical function, depression, anxiety, sleep, social functioning, global physical, mental, and social well-being using National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) measures. The investigators will also examine intervention effects on social isolation, internalized stigma of chronic pain, and experiences of discrimination. The investigators will also conduct focus groups and semi-structured interviews to further understand patient experiences with pain management, patient-clinician relationships, and clinical care in primary care safety net settings.

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/).

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-03-18
• Study First Posted: 2024-03-25
• Study Start: 2024-07-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
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.
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.
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.

Primary Outcome Measures

Name	Time	Method
Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function.	Baseline, 12 weeks, and 24 weeks	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.
Change in Social support and Pain Questionnaire (SPQ)	Baseline, 12 weeks, and 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC)	12 weeks and 24 weeks	Patient belief about treatment efficacy will be measured using a single item patient global impression of change (PGIC). Total score rates from 0 (very much improved) to 6 (very much worse).
Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form	Baseline, 12 weeks, and 24 weeks	Pain catastrophizing will be measured using the Pain Catastrophizing Scale 6-item short form. Total scores range from 0 to 24, with higher scores indicating greater levels of pain catastrophizing.
Change in experiences of discrimination in healthcare	Baseline, 12 weeks, and 24 weeks	Experiences of discrimination in healthcare will be measured using the 7-item Perceived Discrimination in Healthcare Scale. Total scores range from 0 to 28, with high scores indicating greater levels of perceived discrimination in healthcare.
Change in average pain intensity on the 0-10 numeric rating scale	Baseline, 12 weeks, and 24 weeks	Pain intensity in the past 7 days will be measured on the numeric rating scale (NRS), the score ranges from 0-10, with zero indicating no pain and 10 indicating the worst pain imaginable.
Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ)	Baseline, 12 weeks, and 24 weeks	Pain self efficacy will be measured on a 10 item measure Pain Self-Efficacy Questionnaire (PSEQ) developed by Nicholas. Total scores range from 0 to 60 with higher scores indicating stronger self-efficacy beliefs.
Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale	Baseline, 12 weeks, and 24 weeks	Health-related quality of life will be measured using the 4-item NIH PROMIS Global Health Scale which measures sleep disturbance, social functioning, global physical, mental, and social well-being. Total t-scores range from 0 to 100, with higher scores indicating greater well-being.
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 pain interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a survey
Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9)	Baseline, 12 weeks, and 24 weeks	Self-reported depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.
Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2)	Baseline, 12 weeks, and 24 weeks	Self-reported anxiety will be measured using the 2-item Generalized Anxiety (GAD-2). Total scores range from 0 to 6, with higher scores indicating greater levels of anxiety.
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	Self-reported physical function will be measured using the 6-item NIH PROMIS Physical Function Short Form 6b. Total t-scores range from 0 to 100, with higher scores indicating more optimal levels of physical function.
Change in Internalized Stigma of Chronic Pain (ISCP) survey	Baseline, 12 weeks, and 24 weeks	Internalized Stigma of Chronic pain will be measured using the 21-item ISCP, with subscales for enacted and internalized chronic pain stigma. Total scores range from 1 to 4, with high scores indicating greater levels of internalized stigma.
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	Self-reported social isolation will be measured using the 8-item PROMIS Social Isolation Short Form 8a scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation.

Trial Locations

Locations (1)

Tom Waddell Urban Health Clinic; 🇺🇸 San Francisco, California, United States