Changing the Perceived Pain Intensity in Populations With Spinal Cord Injury and With Health Disparities (HAPPINESS):...

Area of Science:

• Integrative medicine
• Pain management
• Rehabilitation

Background:

• Chronic neuropathic pain is prevalent in adults with spinal cord injury (SCI), with limited efficacy and significant risks associated with traditional medication.
• Mind-body interventions like Qigong offer an accessible approach for pain management in SCI, yet require further feasibility studies, especially in diverse populations.
• Previous pilot studies demonstrated Qigong's feasibility in non-Hispanic White adults with SCI, but further research is needed to address health disparities, control group designs, and objective outcome measures.

Purpose of the Study:

• To establish the feasibility and acceptability of a Qigong intervention for adults with SCI experiencing neuropathic pain, including those with health disparities.
• To identify facilitators and barriers to participation in Qigong studies through stakeholder engagement.
• To assess the feasibility of a randomized controlled trial design with objective outcome measures for Qigong in SCI populations.

Main Methods:

• A National Center for Complementary and Integrative Health (NCCIH) R34 feasibility study (HAPPINESS trial) involving 40 SCI stakeholders to identify participation barriers and facilitators.
• A phase I randomized controlled trial with 40 adults with SCI-related neuropathic pain (at least 50% with health disparities) randomized to a 12-week remote Qigong intervention or a pain management survey.
• Collection of feasibility benchmarks, patient-reported outcomes, and objective data from Fitbit Charge 6 watches.

Main Results:

• Participant recruitment commenced on August 20, 2024, with study completion anticipated by January 31, 2027.
• The study is designed to collect comprehensive feasibility data, including recruitment rates, adherence, and participant feedback.
• Objective measures via wearable technology will supplement patient-reported outcomes to assess intervention impact.

Conclusions:

• This feasibility study will provide a robust framework for designing larger effectiveness trials of Qigong and other mind-body interventions for individuals with chronic neurological conditions.
• The findings aim to facilitate the investigation of whole-person health approaches for diverse populations, including those with health disparities.
• Establishing feasibility and acceptability is crucial for advancing evidence-based complementary and integrative health strategies in SCI care.