Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities (HAPPINESS): Protocol for a Feasibility Study.

backgroundChronic 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 and 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.

objectiveThis National Center for Complementary and Integrative Health (NCCIH) R34 feasibility study-the HAPPINESS (Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities) trial-will build upon our prior study to consolidate feasibility with a rigorous protocol. Our aims are (aim 1) to identify facilitators and barriers to participating in a Qigong study through community event meetings, focus groups, and interviews with 40 stakeholders, of whom at least 50% (n=20) have health disparities, and (aim 2) to establish the feasibility of study design and methods through prespecified targets for recruitment and enrollment, feasibility, and acceptability of design and outcomes.

methodsFor aim 1, a total of 40 SCI stakeholders-adults with SCI, caregivers, health care professionals, or other stakeholders who have experience with caring for adults with SCI-will be invited to attend community event meetings, one focus group, or an interview, where they will provide input on facilitators and barriers related to participating in a Qigong study. For aim 2, using a phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain (with at least 50% [n=20] having health disparities) will be randomized to a 12-week remotely delivered Qigong intervention (practicing at least 3×/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, or 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.

resultsThe first participant was recruited on August 20, 2024. Study completion is estimated on January 31, 2027.

conclusionsThe study results will facilitate a rigorous structure to design large effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind and body approaches for whole-person health in adults with chronic or neurological disorders, including those with health disparities.

trial registrationClinicalTrials.gov NCT06140355; https://clinicaltrials.gov/study/NCT06140355. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/82431.