Group-based Integrative Pain Management

Study Overview
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Brief Summary
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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
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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. 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 phase 1 of the 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/).

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: group acupuncture
* Other: Integrative Group Medical Visits


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 factorial trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>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. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit. | |
| Experimental: group acupuncture<br>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. | Other: group acupuncture<br>* 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.<br>|
| Experimental: Integrative Group Medical Visits (IGMV)<br>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. | Other: Integrative Group Medical Visits<br>* 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.<br>|
| Experimental: group acupuncture and IGMV<br>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<br>* 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.<br>Other: Integrative Group Medical Visits<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) survey | 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 and 12 weeks | 
| Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) survey | Self-reported social isolation will be measured using the 8-item PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and 12 weeks | 
| Change in physical functioning on the 4-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) survey | Self-reported physical functioning will be measured using the 4-item NIH PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating more optimal levels of physical functioning. | baseline and 12 weeks | 
| 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 and 12 weeks | 
| 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 and 12 weeks | 
| Change in depressive symptoms on the Patient Health Questionnaire (PHQ-2) | Self-reported depressive symptoms will be measured using the 2-item Patient Health Questionnaire (PHQ-2). Total scores range from 0 to 6, with higher scores indicating greater levels of depressive symptoms. | baseline and 12 weeks | 
| Change in anxiety on the Generalized Anxiety Disorder survey (GAD SF-2) | Self-reported anxiety will be measured using the 2-item Generalized Anxiety (GAD SF-2). Total scores range from 0 to 6, with higher scores indicating greater levels of anxiety. | baseline and 12 weeks | 
| Change in social support in chronic pain scale | Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social Support in Chronic Pain Scale. Total scores range from 0 to 24, with higher scores indicating greater levels of social support. | baseline and 12 weeks | 
| 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 1 (very much worse) to 7 (very much improved) | baseline and 12 weeks | 
| 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 and 12 weeks | 
| Change in health related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) measures | Health related quality of life will be measured using 4 item NIH PROMIS measures for 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 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health equity, integrative health, nonpharmacologic pain management, stigma, social isolation, primary care, group medical visits