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Group-based Integrative Pain Management (IPMP+ Pilot) (IPMP+ Trial)

N/A

Waitlist Available

Led By Maria Chao, DrPH, MPA

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to reduce unequal burden of chronic pain among socioeconomically disadvantaged populations by testing integrative pain management models in primary care clinics.

Eligible Conditions

Chronic Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) survey

Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) survey

Secondary study objectives

Change in Internalized Stigma of Chronic Pain (ISCP) survey

Change in anxiety on the Generalized Anxiety Disorder survey (GAD SF-2)

Change in average pain intensity on the 0-10 numeric rating scale

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: group acupuncture and IGMVExperimental Treatment2 Interventions

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 II: group acupunctureExperimental Treatment1 Intervention

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 III: Integrative Group Medical Visits (IGMV)Experimental Treatment1 Intervention

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 IV: usual careActive Control1 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. 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.

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