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IntroductionAbout 50% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments –some carrying a risk for opioid addiction– highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong will reduce SCI-related neuropathic pain by improving body awareness. We will determine whether remotely delivered Qigong is feasible and whether it reduces neuropathic pain (primary outcome). We will also determine whether it reduces spasms frequency and/or severity, and improves functional performance, mood, or body awareness (secondary outcomes).Methods and analysisIn this quasi-experimental pilot clinical trial study, adults with SCI will practice Qigong at home with a 45min video, at least 3x/week for 12 weeks. The Qigong practice includes movements with guided breathing and is individualized based on functional abilities, i.e., the participants will do kinesthetic imagery of Qigong movements with guided breathing, for movements that they are unable to perform actively. The primary clinical outcome – the highest, average, and lowest neuropathic pain ratings perceived in the prior week–will be recorded weekly throughout the study period. The secondary outcomes will be collected at 4 time points: at baseline, midway during the Qigong intervention (6 weeks), after the Qigong intervention (12 weeks), and after the 6-week follow-up. The data will be analyzed with a repeated measure ANOVA and with Tukey post-hoc tests.Ethics and disseminationThe University of Minnesota (UMN)’s Institutional Review Board (IRB) approved the study (IRB #STUDY00011997). All participants will sign electronic informed consent on the secure UMN REDCap platform. The results will be presented at academic conferences and published in peer-reviewed publications.ClinicalTrial.gov registration numberNCT04917107.ARTICLE SUMMARYStrengths and limitations of this studyThis is the first pilot clinical trial study using Remotely delivered Qigong for neuropathic pain relief in adults with SCI. Data are collected before, and after the intervention as well as after a 6-week follow-up period.This study will provide evidence on the feasibility of remotely delivered Qigong and whether Qigong practice reduces neuropathic pain, and as secondary outcomes, reduces spasms, improves functional performance, mood, or body awareness.Adults with SCI-related neuropathic pain were involved in the design of this study.We did not include a sham version of Qigong and, because there is no group allocation, the assessor, participant, or analyst are not blinded.Because of the relatively small sample size in this study, validation of positive results will need to be validated in a larger sample size, include a control group, and provide a longer follow-up period to address the longer-term duration of the effects. |
