NCT05906784

Group-based Integrative Pain Management (IPMP+ Pilot)

Completed NA Results posted Last updated 30 January 2025

What this trial tests

NA trial testing group acupuncture in Chronic Pain in 44 participants. Completed in 4 December 2023.

Timeline

28 April 2023

Primary endpoint
4 December 2023

4 December 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	44
Start date	28 April 2023
Primary completion	4 December 2023
Estimated completion	4 December 2023
Sites	1 location across United States

Drugs / interventions tested

• group acupuncture
• Integrative Group Medical Visits

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eligible Patients Who Are Randomized Primary · Randomization

Percentage of patients with confirmed eligibility who are randomized

Group	Value	95% CI
Confirmed Eligible	44

Percentage of Randomized Participants Who Complete the Study Secondary · 3-month follow up

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

Group	Value	95% CI
Randomized Participants	40

Intervention Adherence Secondary · 12 weeks

average number of intervention sessions attended

Group	Value	95% CI
Group Acupuncture	8.5	± 2.8
Integrative Group Medical Visits (IGMV)	5.5	± 4.8
Group Acupuncture and IGMV	10.6	± 7.1

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

Group	Value	95% CI
Group Acupuncture	62.4	± 6.6
No Acupuncture	66.4	± 7.2
Integrative Group Medical Visits (IGMV)	65.5	± 7.0
No IGMV	63.4	± 7.3

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

Group	Value	95% CI
Group Acupuncture	52.6	± 10.7
No Acupuncture	55.0	± 7.5
Integrative Group Medical Visits (IGMV)	54.3	± 9.3
No IGMV	53.3	± 9.2

Social Support in Chronic Pain Scale Secondary · 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.

Group	Value	95% CI
Group Acupuncture	12.2	± 6.2
No Acupuncture	14.5	± 5.4
Integrative Group Medical Visits (IGMV)	15.2	± 4.9
No IGMV	11.6	± 6.3

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

Group	Value	95% CI
Group Acupuncture	6.3	± 2.1
No Acupuncture	7.3	± 2.0
Integrative Group Medical Visits (IGMV)	6.7	± 1.9
No IGMV	6.9	± 2.3

Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) Secondary · 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)

Group	Value	95% CI
Usual Care	2.7	± 1.3
Group Acupuncture	4.5	± .7
Integrative Group Medical Visits (IGMV)	4.0	± 1.1
Group Acupuncture and IGMV	4.3	± .7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Group-Based Integrative Pain Management: Feasibility of a Factorial Randomized Trial in Safety-Net Primary Care.
   Thompson-Lastad A, Wennik J, Swedlow P, Wu J, et al · · 2025 · cited 1× · PMID 40817732 · DOI 10.1177/21501319251360113