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group acupuncture for Chronic Pain (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

IPMP+ Trial 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.

IPMP+ Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

IPMP+ 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,427 Total Patients Enrolled
13 Trials studying Chronic Pain
1,757 Patients Enrolled for Chronic Pain
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,610 Total Patients Enrolled
3 Trials studying Chronic Pain
738 Patients Enrolled for Chronic Pain
Maria Chao, DrPH, MPAPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
360 Total Patients Enrolled
1 Trials studying Chronic Pain
360 Patients Enrolled for Chronic Pain

Media Library

Group-based Integrative Pain Management Clinical Trial Eligibility Overview. Trial Name: NCT05906784 — N/A
Chronic Pain Research Study Groups: usual care, group acupuncture, Integrative Group Medical Visits (IGMV), group acupuncture and IGMV
Chronic Pain Clinical Trial 2023: Group-based Integrative Pain Management Highlights & Side Effects. Trial Name: NCT05906784 — N/A
Group-based Integrative Pain Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT05906784 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key aims of this trial?

"This trial seeks to evaluate the efficacy of an intervention by measuring patient-reported outcomes, including Pain Interference on a 8-item NIH PROMIS survey, Physical Functioning through a 4-item NIH PROMIS scale, Self Efficacy in response to pain via the 10 item Nicholas PSEQ measure and Depressive Symptoms using a 2-item PHQ-2. Outcomes will be measured at baseline and 12 weeks after treatment initiation."

Answered by AI

How many volunteers have registered for this experiment?

"Indeed, the trial is now open to enrollment. According to clinicaltrials.gov data, it was posted on April 28th 2023 and last updated June 7th of this year. In total, 40 participants are needed from a single clinic for the study's completion."

Answered by AI

Does this medical study have any openings for participants?

"Per the information on clinicaltrials.gov, this research project is presently enrolling patients. The first posting of the trial was made on April 28th 2023 and has been modified as recently as June 7th 2023."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Tom Waddell Urban Health Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Tom Waddell Urban Health Clinic: < 48 hours
Average response time
  • < 2 Days
~22 spots leftby Apr 2025