Identifying body awareness-related brain network changes after Spring Forest Qigong™ practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial

SUMMARY Background Chronic low back pain (cLBP) affects the quality of life of 52 million Americans and leads to an enormous personal and economic burden. A multidisciplinary approach to cLBP management is recommended. Since medication has limited efficacy and there are mounting concerns about opioid addiction, the American College of Physicians and American Pain Society recommend non-pharmacological interventions, such as mind and body approaches (e.g., Qigong, yoga, Tai Chi) before prescribing medications. Of those, Qigong practice might be most accessible given its gentle movements and because it can be performed standing, sitting, or lying down. The three available Qigong studies in adults with cLBP showed that Qigong reduced pain more than waitlist and equally well than exercise. Yet, the duration and/or frequency of Qigong practice were low (<12 weeks or less than 3x/week). The objectives of this study were to investigate the feasibility of practicing Spring Forest Qigong™ or performing P.Volve low intensity exercises 3x/week for 12 weeks, feasibility of recruitment, data collection, delivery of the intervention as intended, as well as identify estimates of efficacy on brain function and behavioral outcomes after Qigong practice or exercise. To our knowledge, this is the first study investigating the feasibility of the potential effect of Qigong on brain function in adults with cLBP. Methods We conducted a feasibility Phase I Randomized Clinical Trial. Of the 36 adults with cLBP recruited between January 2020 and June 2021, 32 were enrolled and randomized to either 12 weeks of remote Spring Forest Qigong™ practice or remote P.Volve low-intensity exercises. Participants practiced at least 3x/week for 41min/session with online videos. Our main outcome measures were the Numeric Pain Rating Scale (highest, average, and lowest cLBP pain intensity levels in the prior week), assessed weekly and fMRI data (resting-state and task-based fMRI tasks: pain imagery, kinesthetic imagery of a Qigong movement, and robot-guided shape discrimination). We compared baseline resting-state connectivity and brain activation during fMRI tasks in adults with cLBP with data from a healthy control group (n=28) acquired in a prior study. Secondary outcomes included measures of function, disability, body awareness, kinesiophobia, balance, self-efficacy, core muscle strength, and ankle proprioceptive acuity with a custom-build device. Results Feasibility of the study design and methods was demonstrated with 30 participants completing the study (94% retention) and reporting high satisfaction with the programs; 96% adherence to P.Volve low-intensity exercises, and 128% of the required practice intensity for Spring Forest Qigong™ practice. Both groups saw promising reductions in low back pain (effect sizes Cohen’s d =1.01-2.22) and in most other outcomes ( d =0.90-2.33). Markers of ankle proprioception were not significantly elevated in the cLBP group after the interventions. Brain imaging analysis showed weaker parietal operculum and insula network connectivity in adults with cLBP (n=26), compared to data from a healthy control group (n=28). The pain imagery task elicited lower brain activation of insula, parietal operculum, angular gyrus and supramarginal gyrus at baseline in adults with cLBP than in healthy adults. Adults with cLBP had lower precentral gyrus activation than healthy adults for the Qigong movement and robot task at baseline. Pre-post brain function changes showed individual variability: Six (out of 13) participants in the Qigong group showed increased activation in the parietal operculum, angular gyrus, supramarginal gyrus, and precentral gyrus during the Qigong fMRI task. Interpretation Our data indicate the feasibility and acceptability of using Spring Forest Qigong™ practice or P.Volve low-intensity exercises for cLBP relief showing promising results in terms of pain relief and associated symptoms. Our brain imaging results indicated brain function improvements after 12 weeks of Qigong practice in some participants, pointing to the need for further investigation in larger studies. Trial registration number ClinicalTrials.gov: NCT04164225 .