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

Chronic Pain Clinical Trial

— IPMP+  

Official title:

Group-based Integrative Pain Management: A Multi-level Approach to Address Intersectional Stigma and Social Isolation in Diverse Primary Care Safety Net Patients With Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327542
• Other study ID #: 22-37078B
• Secondary ID: 1R61MD018333
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: Julia Wu, MPH
• Phone: 415-502-8733
• Email: Julia.Wu[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Group Acupuncture
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.
• Integrative Group Medical Visits
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.

Locations

Country	Name	City	State
United States	Tom Waddell Urban Health Clinic	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in average pain intensity on the 0-10 numeric rating scale	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.	Baseline, 12 weeks, and 24 weeks
Secondary	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.	Change in pain interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a survey	Baseline, 12 weeks, and 24 weeks
Secondary	Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in Internalized Stigma of Chronic Pain (ISCP) survey	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ)	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9)	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2)	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC)	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).	12 weeks and 24 weeks
Secondary	Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale	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.	Baseline, 12 weeks, and 24 weeks
Secondary	Change in experiences of discrimination in healthcare	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.	Baseline, 12 weeks, and 24 weeks