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Completed

NCT Number: NCT05906784

Group-based Integrative Pain Management (IPMP+ Pilot)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Waddell Urban Health Clinic

San Francisco, California, 94102, United States

About this study

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/).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Eligible Patients Who Are Randomized

    Time frame: Randomization

    Percentage of patients with confirmed eligibility who are randomized

Secondary outcomes

  1. Percentage of Randomized Participants Who Complete the Study

    Time frame: 3-month follow up

    Retention as percentage of randomized who complete 3-month follow up survey

  2. Intervention Adherence

    Time frame: 12 weeks

    average number of intervention sessions attended

Other outcomes

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

    Time frame: 3-month follow up

    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.

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

    Time frame: 3-month follow up

    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.

  3. Social Support in Chronic Pain Scale

    Time frame: 3-month follow up

    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.

  4. Average Pain Intensity on the 0-10 Numeric Rating Scale

    Time frame: 3-month follow up

    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.

  5. Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC)

    Time frame: 3-month follow up

    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)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Pilot Phase of 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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