Qigong for Spinal Cord Injury

Overseen By Ann Van de Winckel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Uncontrolled seizures, Cognitive impairment, Ventilator dependency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Qigong, a gentle mind-body practice focusing on movement and breathing, can reduce neuropathic pain in people with spinal cord injuries. Many experience long-term pain that disrupts daily activities like mobility and sleep, and current treatments often prove insufficient. Participants will begin with either a 12-week period of Qigong or an observation period, followed by the other. The trial seeks individuals who have had a spinal cord injury for at least three months, experience significant neuropathic pain, and are otherwise medically stable. As an unphased trial, this study offers a unique opportunity to explore alternative pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Qigong is safe for individuals with spinal cord injury?

Research has shown that Qigong is generally safe for individuals with spinal cord injuries. Several studies have examined its safety, particularly when practiced remotely, and have not identified any major negative effects. This indicates that people can practice Qigong without significant risk.

For instance, one study on "Five Element Qigong Healing Movements" found it suitable for adults with nerve pain from spinal cord injuries. Participants performed the movements without major problems, and no harmful side effects were reported.

In summary, while further research could provide additional confirmation, current evidence suggests that Qigong is a safe option for managing nerve pain in individuals with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Qigong for spinal cord injury because it offers a non-invasive, holistic approach that differs from traditional treatments like surgery or medications that focus on symptom management. Qigong is a form of ancient Chinese exercise that combines gentle movements, breathing techniques, and meditation, making it unique as it promotes healing and rehabilitation through mind-body connection and stress reduction. This method may not only help improve physical function but also enhance overall well-being, offering a complementary option that is both low-risk and accessible.

What evidence suggests that Qigong might be an effective treatment for spinal cord injury-related neuropathic pain?

Research has shown that Qigong might help reduce nerve pain in people with spinal cord injuries. A small study found that adults with this type of pain can practice Spring Forest Qigong from home. Participants experienced less pain after using a specific practice called "Five Element Qigong Healing Movements." This method can be done remotely, offering convenience. In this trial, participants will either start with a 12-week Qigong intervention or begin with a 12-week observation period before switching. While more research is needed, these early results suggest that Qigong could improve life for those with spinal cord injury pain. ^{2 5 6 7 8}

Who Is on the Research Team?

Ann Van de Winckel, PhD, MS, PT

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with spinal cord injury who experience neuropathic pain above a certain level. They must be medically stable, have had the injury for at least 3 months, and not depend on a ventilator. People can't join if they're pregnant, planning to become pregnant, have cognitive impairments that prevent following directions, seizures that aren't controlled, or can't undergo MRI scans.

Inclusion Criteria

I have had a spinal cord injury for at least 3 months.

I have stable paraplegia or tetraplegia.

My spinal cord injury pain is more than 3 on a scale of 0-10.

Exclusion Criteria

I do not have seizures, cognitive issues, or communication disabilities that prevent me from following instructions.

You cannot have an MRI if you have certain metal implants in your body.

If you can't feel movements in your index finger, you won't do the robot task, but you will do all the other scans in the MRI machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo a 12-week observation period to assess baseline measures

12 weeks

Regular virtual check-ins

Qigong Intervention

Participants receive Qigong practice for 12 weeks to assess its impact on neuropathic pain and body awareness

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after the Qigong intervention

6 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Qigong

Trial Overview

The CREATION trial is testing Qigong—a mind-body practice involving gentle movements and focused breathing—as a potential treatment to reduce neuropathic pain in individuals with spinal cord injuries. The study includes an optional substudy where all participants will practice Qigong for 12 weeks followed by a 6-week follow-up.

How Is the Trial Designed?

Group I: Qigong First Experimental Treatment 1 Intervention

Participants in this group will complete the 12-week Qigong intervention first and then the 12-week observation period.

Group II: Observation First Experimental Treatment 1 Intervention

Participants in this group will complete the 12-week observation period first and then the 12-week Qigong intervention.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a rat model of spinal cord injury, treatment with Buyang huanwu decoction (BYHWD) at low, medium, and high doses significantly improved forelimb motor function and increased the survival of neurons in the red nucleus.

The neuroprotective effects of BYHWD are likely linked to its modulation of the mTOR signaling pathway and reduction of autophagy markers, suggesting a potential mechanism for promoting recovery after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buyang Huanwu decoction improves neural recovery after spinal cord injury in rats through the mTOR signaling pathway and autophagy. Nie, Y., Fan, Y., Zhang, X., et al.[2023]

A systematic review of 47 trials involving 3877 participants found that Baduanjin exercise is generally safe, with only two studies reporting adverse events such as muscle ache, palpitation, and dizziness.

Despite the low incidence of reported adverse events, the review highlights the need for better monitoring protocols in future studies to ensure comprehensive safety assessments of Baduanjin exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Baduanjin Exercise: A Systematic Review. Fang, J., Zhang, L., Wu, F., et al.[2022]

This systematic review aims to comprehensively analyze existing systematic reviews on the adverse events associated with Qigong and related therapies, highlighting the need for better understanding of their safety.

The findings will provide valuable insights for clinicians, practitioners, and patients regarding the safe application of Qigong in clinical and daily life settings, while also guiding future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Qigong: Protocol for an overview of systematic reviews. Guo, Y., Xu, MM., Huang, Y., et al.[2022]

A remote Qigong intervention was found to be feasible and effective in reducing neuropathic pain in adults with spinal cord injury, with pain levels decreasing from an average of 7.94 to 4.17 on the Numeric Pain Rating Scale after 12 weeks of practice.

Participants also reported significant improvements in related symptoms, including reduced spasm frequency and severity, better mood, and enhanced ability to perform daily activities, indicating a holistic benefit from the Qigong practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial. Van de Winckel, A., Carpentier, ST., Deng, W., et al.[2023]

A systematic review of 7 randomized controlled trials involving acupuncture for spinal cord injury (SCI) patients suggests that acupuncture may positively impact functional recovery and bladder dysfunction, although the overall quality of the studies is poor.

Pooled analysis of two trials indicated that acupuncture was significantly more effective than conventional treatment for bladder dysfunction, with a relative risk of 1.51, highlighting its potential as a beneficial intervention in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review. Shin, BC., Lee, MS., Kong, JC., et al.[2022]

Acupuncture may enhance neural plasticity and improve recovery outcomes in patients with acute spinal cord injuries, particularly when applied within the first 12 to 15 weeks post-injury, which is the critical period for motor and sensory recovery.

In a case study of an incomplete T5 spinal cord injury, scalp acupuncture treatments were associated with better restoration of nervous system communication, suggesting its potential as a beneficial therapy in both hospital and rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp Acupuncture for the Treatment of Motor Function in Acute Spinal Cord Injury: A Case Report. Widrin, C.[2018]

A 12-week health Qigong intervention significantly reduced body fat and increased skeletal muscle mass in 108 sedentary young and middle-aged participants, indicating its efficacy in improving physical health.

Participants who practiced health Qigong also experienced significant improvements in the range of motion in their cervical vertebrae and better mental health outcomes, including reduced symptoms of anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Health Qigong in Improving the Cervical and Lumbar Disc Disease and Mental Health Status of Sedentary Young and Middle-Aged Faculties. Li, B.[2022]

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

A remotely delivered Qigong intervention was feasible for adults with chronic neuropathic pain due to spinal cord injury, with 18 out of 23 recruited participants completing the study and showing good adherence to the practice.

Participants experienced significant reductions in neuropathic pain intensity from an average of 7.94 to 4.17 on the Numeric Pain Rating Scale after 12 weeks, with improvements in related symptoms such as mood and daily activities persisting at 6-week and 1-year follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study. Van de Winckel, A., Carpentier, ST., Deng, W., et al.[2023]

This pilot clinical trial aims to evaluate the feasibility and effectiveness of Spring Forest Qigong™ in reducing neuropathic pain among adults with spinal cord injury (SCI), with participants practicing at home for 12 weeks using guided video sessions.

The study will assess changes in neuropathic pain and related factors such as mood and body awareness, with data collected at multiple time points to determine the intervention's impact and long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial. Van de Winckel, A., Carpentier, S., Deng, W., et al.[2023]

Acupuncture has been shown to improve motor function in patients with spinal cord injuries during their rehabilitation phase.

The study discusses the mechanisms of how acupuncture works in this context, based on years of clinical practice and personal insights from the author.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on acupuncture and moxibustion for treatment of spinal cord injury at the rehabilitation stage]. Qi, QH.[2007]

Qigong significantly improves activities of daily living (ADL) and life quality in stroke patients, as shown by a meta-analysis of 16 randomized controlled trials involving 1253 participants, with notable improvements in the Barthel Index and Stroke-Specific Quality of Life Scale.

Longer durations of Qigong intervention are more effective in enhancing daily living activities compared to shorter interventions, indicating that sustained practice may lead to better rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Qigong exercise on non-motor function and life quality in stroke patients: A systematic review and meta-analysis. Lan, Y., You, Q., Jiang, Q., et al.[2023]

In a study of 51 patients with spinal cord injury, those receiving early comprehensive therapy of Traditional Chinese Medicine (TCM) showed significant improvements in motor function and daily living activities after 4 weeks of treatment.

While TCM therapy improved motor scores and the Barthel Index, there was no significant difference in overall ASIA grading compared to the control group receiving Western Medicine, suggesting that TCM may enhance specific motor functions but not overall injury classification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Chinese Medicine comprehensive therapy for the improvement of motor function in spinal cord injury patients. Wang, Y., Zhang, L., Pan, G., et al.[2019]

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