Qigong for Spinal Cord Injury

Recruiting at 2 trial locations

Overseen By Ann Van de Winckel, PhD, MSPT, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Uncontrolled seizures, Cognitive impairment, Ventilator dependency, Major medical complications, Pressure ulcers, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether practicing Qigong, a gentle mind-body exercise, can reduce chronic neuropathic pain in people with spinal cord injuries. Participants will either practice Qigong exercises remotely for 12 weeks or complete a brief daily pain survey. The study aims to assess the effectiveness of this approach and identify factors influencing adherence. Ideal participants are those with spinal cord injuries experiencing significant neuropathic pain, who have stable medical conditions, and who can access the internet and a device for remote participation. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pain management strategies for spinal cord injuries.

Do I need to stop my current medications for the Qigong trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the study coordinators.

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

Research has shown that practicing Qigong remotely is generally safe for people with spinal cord injuries who experience nerve pain. In one study with 23 adults, participants who practiced Qigong for 12 weeks reported a 44% decrease in pain. Importantly, those who completed the study reported no major side effects, suggesting that Qigong is well-tolerated. While more research with larger and more varied groups is needed, these early results are promising for those considering this mind-body method for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury-related neuropathic pain, which often rely on medications like opioids or anticonvulsants, Qigong offers a non-pharmacological approach. Researchers are excited about Qigong because it combines gentle movements, breathing exercises, and meditation to potentially reduce pain and improve quality of life without the side effects associated with drugs. This mind-body practice could offer a holistic, accessible option for diverse groups of patients, promoting both physical and mental well-being.

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

Research has shown that Qigong, an ancient practice combining gentle movements and focused breathing, may help reduce long-term nerve pain in people with spinal cord injuries (SCI). In a previous study, participants who practiced Qigong reported a 44% decrease in pain after 12 weeks, with this improvement persisting at both the 6-week and 1-year check-ins. The practice might help manage pain by promoting relaxation and better blood flow. This trial will compare an experimental group practicing Qigong with an active comparison group to further investigate its effectiveness. While the results are promising, more research is needed to confirm these findings in different groups of people with SCI. ^{1 2 4 6 7}

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?

The HAPPINESS Trial is for adults over 18 with spinal cord injury and chronic neuropathic pain who can participate in remote Qigong sessions. Participants need internet access, a computer or smartphone, and must speak English or Spanish. They should be medically stable with measurable neuropathic pain.

Inclusion Criteria

Access to the internet and a computer/iPad or smartphone

I am willing to do Qigong exercises online.

My health condition is currently stable.

Exclusion Criteria

Ventilator dependency

Regular Tai Chi or Qigong practice in the past 6 months (3x/week or more)

Currently engaged in other rehabilitation programs that would influence outcomes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to a 12-week remote Qigong intervention or a short daily pain management survey

12 weeks

Weekly check-ins (virtual), monthly 1:1 Qigong session via Zoom

Follow-up

Participants are monitored for adherence and outcomes post-intervention

6 months

Monthly follow-up (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Qigong

Trial Overview This trial tests the feasibility of a 12-week remote Qigong program versus daily pain management surveys to manage SCI-related neuropathic pain. It aims to establish if these methods are practical and acceptable, especially among diverse populations including Hispanics, veterans, and rural residents.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to experimental group

Group II: Active comparison group Active Control 1 Intervention

adults with SCI-related neuropathic pain with at least 50% from diverse groups randomized to active comparator group

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37719467/

Feasibility of using remotely delivered Spring Forest Qigong to ... Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36824929/

Using remotely delivered Spring Forest Qigong™ to reduce ... The manuscript proposes the feasibility and potential of a remote Qigong intervention to reduce neuropathic pain in adults with spinal cord injury (SCI)- ...

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1222616/full

Feasibility of using remotely delivered Spring Forest ... Remote Spring Forest Qigong's “Five Element Qigong Healing Movements” practice is feasible in adults with SCI-related neuropathic pain.

4. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-023-01374-3

Using remotely delivered Spring Forest Qigong™ to reduce ... We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations ...

5. datadryad.org datadryad.org/dataset/doi:10.5061/dryad.6t1g1jx43

Data: Feasibility of using remotely delivered Spring Forest ... Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: A pilot study · Data ...

6. medrxiv.org medrxiv.org/content/10.1101/2022.03.09.22271844.full

Using remotely delivered Spring Forest Qigong ... - medRxiv In this study, we will test our hypothesis that Spring Forest Qigong TM will reduce SCI-related neuropathic pain by improving body awareness.

7. researchgate.net researchgate.net/publication/373298388_Using_remotely_delivered_Spring_Forest_Qigong_to_reduce_neuropathic_pain_in_adults_with_spinal_cord_injury_protocol_of_a_quasi-experimental_feasibility_clinical_trial

Using remotely delivered Spring Forest Qigong™ to reduce ... We will determine whether remotely delivered Qigong is feasible and we will collect data on neuropathic pain, and other reported associations with pain such as ...