PROJECT SUMMARY
Chronic neuropathic pain impacts up to 69% of adults with spinal cord injury (SCI). Current accessible treat- ment options are limited and are 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 not enough evidence to make rec- ommendations 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 neu- ropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong more (138%) than the required intensity (at least 3x/week with Qigong video through the internet). The 18 participants had an average age of 59 years, were on average 15 years post-SCI, 33% were women, 39% were older adults, 33% lived in rural areas, 17% were veterans, 67% were in socio-eco- nomic distress, 56% had paraplegia, 44% had tetraplegia, 33% had a complete SCI, and all were non-Hispanic Whites. Their pain was reduced by 44% after 12 weeks of Qigong and was still reduced at the 6-week and 1- year follow-up. However, despite the promising data, 3 key elements are missing and need to be addressed before performing a larger effectiveness study: lack of data from adults with SCI from diverse backgrounds on
(1) feasibility and acceptability of participating in a Qigong study; (2) on the feasibility of the study design (in- cluding a control group) and Qigong adherence; as well as (3) the lack of objective outcome measures.
This R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe popu- lations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous proto- col. Our diverse multidisciplinary team is uniquely qualified to address the following aims: AIM 1. To identify the facilitators/barriers to participating in a Qigong study through focus groups and interviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM
2. To establish the feasibility of study design/methods of the HAPPINESS trial in adults with SCI (with at least 50% from diverse backgrounds) through pre-specified targets for recruitment/enrollment, feasibility, and ac-ceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-re-lated neuropathic pain will be randomized to 12-week remote Qigong intervention or pain management with a HIPAA-compliant ‘Manage My Pain Pro app + 6-month follow-up. Aligned with NCCIH’s mission and its top re- search priorities, 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 (including pain management) in diverse groups of adults with chronic/neurological disorders.
