cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain, but there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. To support our feasibility study, we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong 138% of the required intensity (which was, at least 3x/week with Qigong video through the internet). Their pain was reduced by 44% after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up. However, three key elements need to be addressed before performing a larger effectiveness study: (1) feasibility/acceptability of Qigong from adults with SCI of diverse backgrounds; (2) feasibility of the study design with control group); and (3) objective outcome measures. This R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous protocol. We will address the following aims: AIM 1. Identify the facilitators/barriers to participating in a Qigong study through focus groups/interviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM 2. Establish the feasibility of study design/methods of the HAPPINESS trial in adults with SCI (at least 50% of diverse backgrounds) through pre-specified targets for recruitment/enrollment, feasibility, and acceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phone/iPad/computer + 6-month follow-up. The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronic/neurological disorders.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18+ years old

• medically stable

• with neuropathic pain 4 or above on the numeric pain rating scale + screened with painDETECT

• willing to participate in a remote Qigong intervention (from any location with internet connection)

• fluent in English or Spanish

• access to the internet and a computer/iPad or smartphone

Locations
United States
Florida
University of Miami
NOT_YET_RECRUITING
Miami
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Texas
University of Texas - Rio Grande Valley
NOT_YET_RECRUITING
Harlingen
Contact Information
Primary
Ann Van de Winckel, PhD, MSPT, PT
avandewi@umn.edu
612-625-1191
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 40
Treatments
Experimental: Experimental group
adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group
Active_comparator: Active comparison group
adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov