Qigong for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Ann Van de Winckel, PhD, MS, PT

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic neuropathic pain affects 69% of adults with spinal cord injury (SCI). Current treatment options are limited (primarily pain medications) with insufficient benefits and significant risks for addiction and adverse effects. Of the available mind and body approaches, Qigong is the most accessible for adults with SCI with evidence for effectiveness in reducing pain, but there is insufficient evidence to make recommendations for adults with SCI. Thus, the feasibility of Qigong in SCI needs to be established. To support our feasibility study, we investigated a 12-week remote Qigong program in adults with SCI and neuropathic pain. We recruited 23 adults with SCI, 18 completed the study, and 12 completed the 1-year follow-up. They practiced Qigong 138% of the required intensity (which was, at least 3x/week with Qigong video through the internet). Their pain was reduced by 44% after 12 weeks of Qigong practice and was still reduced at the 6-week and 1-year follow-up. However, three key elements need to be addressed before performing a larger effectiveness study: (1) feasibility/acceptability of Qigong from adults with SCI of diverse backgrounds; (2) feasibility of the study design with control group); and (3) objective outcome measures. This R34 feasibility study, the HAPPINESS trial (cHAnging the Perceived Pain INtensity in divErSe populations with Spinal cord injury), will expand on our prior study to consolidate feasibility with a rigorous protocol. We will address the following aims: AIM 1. Identify the facilitators/barriers to participating in a Qigong study through focus groups/interviews with stakeholders from diverse backgrounds, defined as Hispanics, veterans, and adults living in rural, underserved areas. AIM 2. Establish the feasibility of study design/methods of the HAPPINESS trial in adults with SCI (at least 50% of diverse backgrounds) through pre-specified targets for recruitment/enrollment, feasibility, and acceptability of design and outcomes. Using a Phase I randomized controlled trial design, 40 adults with SCI-related neuropathic pain will be randomized to 12-week remote Qigong intervention OR a short daily pain management survey that can be completed on phone/iPad/computer + 6-month follow-up. The study results will facilitate a rigorous structure to design larger effectiveness studies and facilitate a clear pathway for researchers to investigate Qigong and other mind-body approaches for whole-person health in diverse groups of adults with chronic/neurological disorders.

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 data supports the effectiveness of the treatment Qigong for spinal cord injury?

Research suggests that Spring Forest Qigong, a type of Qigong, may help reduce neuropathic pain in people with spinal cord injuries by improving body awareness. This is important because neuropathic pain is often difficult to treat with traditional methods. ^{1 2 3 4 5}

Is Qigong generally safe for humans?

Qigong is generally considered safe, but the understanding of its potential side effects is not complete. A review of existing studies aims to provide more comprehensive information on any adverse events associated with Qigong and related therapies. ^{6 7 8 9 10}

How does the Qigong treatment for spinal cord injury differ from other treatments?

Qigong is unique because it is a non-drug therapy that involves gentle movements and kinesthetic imagery to improve body awareness and reduce neuropathic pain, which is often resistant to other treatments. It can be practiced remotely, making it accessible and convenient for individuals with spinal cord injury. ^{1 2 11 12 13}

Research Team

Ann Van de Winckel, PhD, MS, PT

Principal Investigator

University of Minnesota

Eligibility Criteria

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 18 years old or older.

I am willing to do Qigong exercises online.

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

Trial Timeline

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)

Treatment Details

Interventions

• Qigong (Behavioral Intervention)

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.

Participant Groups

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+

Shashank Priya

University of Minnesota

Chief Executive Officer since 2023

PhD in Materials Engineering from Penn State

Charles Semba

University of Minnesota

Chief Medical Officer since 2021

MD from the University of Minnesota Medical School

Findings from Research

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]

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 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 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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Buyang Huanwu decoction improves neural recovery after spinal cord injury in rats through the mTOR signaling pathway and autophagy. [2023]

3. United States 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. [2023]

4. Scotland pubmed.ncbi.nlm.nih.gov

Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Traditional Chinese Medicine comprehensive therapy for the improvement of motor function in spinal cord injury patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Qigong: Protocol for an overview of systematic reviews. [2022]

7. United States 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. [2023]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Safety of Baduanjin Exercise: A Systematic Review. [2022]

10. Iran 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. [2022]

11. Switzerland 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. [2023]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

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

13. China pubmed.ncbi.nlm.nih.gov

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