The HAPPINESS Trial: cHAnging the Perceived Pain INtensity in divErSe Populations With Spinal Cord Injury - Trial NCT06140355

Timeline & Enrollment

Primary Outcome

recruitment rates,the recruitment rate for complete and incomplete SCI,Attrition rates in Qigong and Manage My Pain app group.,intervention adherence,the frequency of use of the Manage My Pain app (recommended daily check in),Feasibility of adhering to the collection of quantitative measure 1,Feasibility of adhering to the collection of quantitative measure 2

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 pain management
 with a 'Manage My Pain Pro app + 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.

ICD-10 Classifications