Clinical trial NCT04917107: CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults With Spinal Cord Injury
Official title: CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Delayed design
Primary purpose: TREATMENT

Brief summary: Between 39-67% of the 294,000 Americans who have a SCI suffer from long-term debilitating neuropathic pain, interfering with rehabilitation, general activity, mobility, mood, sleep, and quality of life. Pain can hinder any potential for functional improvement that could be obtained during rehabilitation. Yet, neuropathic pain is refractory to many treatments. Current interventions, such as medications and physical therapy, result in less than 50% reduction in pain for only about one third of the people trying them, calling for new treatment options.

Qigong, a mind and body approach that incorporates gentle body movements, paired with a focus on breathing and body awareness to promote health and wellness, could reduce SCI-related neuropathic pain. If the hypothesis is supported, the resulting work could be transformative in demonstrating a potentially effective therapy for civilians, military Service members, and Veterans with SCI and neuropathic pain. The following provides the scientific basis for this hypothesis and establishes the rationale for this approach.

This study also includes an optional, remote, quasi-experimental substudy, in which all participants will receive Qigong for 12 weeks, followed by 6 weeks followup.

Detailed description: Neuropathic pain in adults with spinal cord injury (SCI) has been attributed to altered pain processing-related brain function. However, recent studies showed that SCI-related brain alterations impact more than pain perception alone, because adults with SCI also have altered body awareness. As suggested by previous brain imaging studies, SCI-related neuropathic pain could be viewed as part of a broader body awareness deficit, affecting connectivity with two brain areas -the parietal operculum (parts OP1/OP4) and the insula- which are essential for the formation of body awareness as well as for pain perception. Previous data imply that improving body awareness could restore the altered pain pathways and lead to neuropathic pain relief. However, for SCI, restoring the pain pathways and relieving neuropathic pain through body awareness training have been a challenge in the rehabilitation field. In this proposal, the investigators will test the hypothesis that Qigong -a mind and body approach that incorporates gentle body movements, paired with a focus on breathing and body awareness to promote health and wellness- could reduce SCI-related neuropathic pain by improving body awareness. Enhancing body awareness may also be beneficial for adults with "discomplete" SCI, characterized by complete transection as judged by clinical criteria, but with neurophysiological evidence of conduction through the level of damage.

The central hypothesis is that Qigong restores body awareness and sensory and pain perception processing through restoring OP1/OP4 and insula connectivity, thereby reducing or relieving pain. It is further hypothesized that Qigong practice is feasible and safe for adults with SCI and that kinesthetic imagery of Qigong movements (for those unable to perform arm movements) versus performing the movements will have the same effect on brain function in key pain areas, and on reducing pain. If these hypotheses are supported, the outcomes could be transformative in (i) showing a potentially effective therapy for neuropathic pain relief that can be done at home, (ii) delineating underlying neural mechanisms of how Qigong relieves neuropathic pain, and (iii) demonstrating that body awareness training can improve signal conduction in discomplete SCI.

Specific Aim 1: Determine whether 12 weeks of Qigong is feasible and well tolerated in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).

Specific Aim 2: Determine whether 12 weeks of Qigong practice reduces moderate to severe below-level neuropathic pain in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).

Specific Aim 3: Determine whether 12 weeks of Qigong practice restores brain activity and connectivity related to pain processing in adults with SCI.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury of greater than or equal to 3 months
* Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
* Highest level of below-level SCI-related neuropathic pain \>3 on the numeric pain rating scale.

Exclusion Criteria:

* MRI contra-indications (stabilizing hardware is typically MRI safe)
* Uncontrolled seizure disorder; cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent the participant from following directions or from learning
* Ventilator dependency
* Pregnancy to plans to become pregnant during study
* Inability to perform kinesthetic imagery.
* Participants who cannot feel index finger movements will not perform the robot task but will perform all other resting-state and tasks in the MRI scanner.

Primary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 24 weeks
measure: Change in WHOQOL-BREF
timeFrame: 24 weeks
measure: Change in The Revised Body Awareness Rating Questionnaire (BARQ)
timeFrame: 24 weeks
measure: Change in The Moorong Self-Efficacy Scale (MSES)
timeFrame: 24 weeks
measure: Change in The Tampa Scale for Kinesiophobia (TSK)
timeFrame: 24 weeks
measure: Change in the Physical Activity Enjoyment Scale (PACES)
timeFrame: 24 weeks
measure: Change in the Sydney Psychosocial Reintegration Scale (SPRS)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ann Van de Winckel, PhD, MSPT, PT
role: PRINCIPAL_INVESTIGATOR
References: