JMIR Publications

ABSTRACT

Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Medication, as a primary treatment, has 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. Still, there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. We previously demonstrated feasibility in a pilot study, in which 18 non-Hispanic White adults with SCI completed a 12-week remote Qigong program. However, three additional key elements need to be addressed before performing a larger effectiveness study: (1) feasibility/acceptability of Qigong in adults with SCI with health disparities; (2) feasibility of a study design with a control group; and (3) objective outcome measures. This National Center for Complementary and Integrative Health (NCCIH) R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtEnSity in populations with Spinal cord injury and with health disparities), will build upon our prior study to consolidate feasibility with a rigorous protocol. Our aims are: AIM 1. Identify facilitators/barriers to participating in a Qigong study through focus groups/interviews with 40 stakeholders, of whom at least 50% have health disparities. AIM 2. Establish the feasibility of study design/methods 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 (with at least 50% with health disparities) will be randomized to a 12-week remotely-delivered Qigong intervention (practicing at least 3x/week with the Spring Forest Qigong’s “Five Element Qigong Healing Movements” video), OR a short daily pain management survey, completed on a smartphone/iPad/computer + 6-month follow-up. Feasibility benchmarks, as well as patient-reported outcome measures and objective data from the Fitbit Charge 6 watch, will be collected during the study. 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 adults with chronic/neurological disorders, including those with health disparities. Trial registration: ClinicalTrial.gov registration number: NCT06140355, first posted 11/20/2023. https://clinicaltrials.gov/study/NCT06140355?cond=Spinal%20Cord%20Injury&term=Happiness&rank=1