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, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if Qigong, a practice involving gentle movements and focused breathing, can reduce chronic pain in adults with spinal cord injuries by improving their body awareness and correcting brain function related to pain. Qigong is a therapeutic Chinese practice that has been used for thousands of years to optimize and restore energy (Qi) to the body, mind, and spirit.
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 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.
12345Is 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.
678910How does the Qigong treatment for spinal cord injury differ from other treatments?
Qigong is unique because it is a non-invasive, movement-based therapy that can be practiced remotely, focusing on improving body awareness to reduce neuropathic pain, unlike many standard treatments that may involve medications or surgeries.
34111213Eligibility Criteria
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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Qigong FirstExperimental Treatment1 Intervention
Participants in this group will complete the 12-week Qigong intervention first and then the 12-week observation period.
Group II: Observation FirstExperimental Treatment1 Intervention
Participants in this group will complete the 12-week observation period first and then the 12-week Qigong intervention.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
References
Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial. [2023]The manuscript proposes the feasibility and potential of a remote Qigong intervention to reduce neuropathic pain in adults with spinal cord injury (SCI)-related neuropathic pain.
Traditional Chinese Medicine comprehensive therapy for the improvement of motor function in spinal cord injury patients. [2019]To study the effect of early comprehensive therapy of Traditional Chinese Medicine (TCM) on motor function of in patients with spinal cord injury.
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]About 69% of Americans living with spinal cord injury (SCI) suffer from long-term debilitating neuropathic pain, interfering with the quality of daily life. Neuropathic pain is refractory to many available treatments-some carrying a risk for opioid addiction-highlighting an urgent need for new treatments. In this study, we will test our hypothesis that Spring Forest Qigong™ will reduce SCI-related neuropathic pain by improving body awareness. 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 spasms frequency and/or severity, functional performance, mood, and body awareness.
Buyang Huanwu decoction improves neural recovery after spinal cord injury in rats through the mTOR signaling pathway and autophagy. [2023]Spinal cord injury (SCI) refers to the interruption of the tracts inside the spinal cord caused by various factors. The repair of damaged axons has always been a difficult point in clinical treatment and neuroscience research. The treatment of SCI with Buyang huanwu decoction (BYHWD), a well-known recipe for invigorating Qi (a vital force forming part of any living entity in traditional Chinese culture) and promoting blood circulation, shows a good effect.
Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review. [2022]To systematically review Chinese literature on the effectiveness of acupuncture for treating patients with spinal cord injury (SCI).
The Safety of Baduanjin Exercise: A Systematic Review. [2022]Baduanjin exercise is a form of Qigong exercise therapy that has become increasingly popular worldwide. The aims of the current systematic review were to summarize reported adverse events potentially associated with Baduanjin exercise based on currently available literature and to evaluate the quality of the methods used to monitor adverse events in the trials assessed.
Effects of Health Qigong in Improving the Cervical and Lumbar Disc Disease and Mental Health Status of Sedentary Young and Middle-Aged Faculties. [2022]Shoulder, neck, and back discomforts and abdominal obesity caused by sedentariness are increasingly prominent in young and middle-aged population groups. Health Qigong improves physical functions and strengthens the disease resistance of exercisers. This study aims to explore health Qigong intervention's effects on the cervical vertebra, lumbar vertebra, and mental status.
Safety of Qigong: Protocol for an overview of systematic reviews. [2022]Qigong, as one of the essential elements of Traditional Chinese exercises, has been used to improve physical and psychological health and combat diseases in China for thousands of years. In recent years, the beneficial effects of Qigong on different medical conditions are becoming more accepted by both patients and health care providers. Although it is a common impression that Qigong and related therapies are generally safe procedures, but the current understanding of its adverse events is fragmented. Thus, we conducted this overview to synthesize comprehensively existing systematic reviews on adverse events associated with Qigong and related therapies, and our findings can be used to informing clinicians, Qigong practitioner, and patients alike on applying such treatments or interventions in clinical treatment and daily life training mindful manner, and provide a guideline for researchers in future.
Effect of Qigong exercise on non-motor function and life quality in stroke patients: A systematic review and meta-analysis. [2023]Qigong have a positive impact on the rehabilitation of motor function in stroke survivors, but there is no consensus on the effectiveness of Qigong on activities of daily living (ADL), neurological function, and life quality for patients with stroke. We aimed to quantitatively evaluate the effect of Qigong on non-motor function and life quality in stroke patients.
What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. [2022]To systematically review the frequency and quality of adverse event (AE) reports in randomized controlled trials (RCTs) of tai chi (TC).
Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study. [2023]Introduction: Approximately 69% of 299,000 Americans with spinal cord injury (SCI) suffer debilitating chronic neuropathic pain, which is intractable to treatment. The aim of this study is to determine feasibility, as the primary objective, and estimates of efficacy of a remotely delivered Qigong intervention in adults with SCI-related neuropathic pain, as the secondary objective. Methods: We recruited adults with SCI-related neuropathic pain, with SCI ≥3 months, with complete or incomplete SCI, and highest neuropathic pain level of >3 on the Numeric Pain Rating Scale (NPRS), using nationwide volunteer sampling. Using a non-randomized controlled trial design, participants practiced Spring Forest Qigong's "Five Element Qigong Healing Movements" (online video) by combining movement to the best of their ability with kinesthetic imagery, at least 3x/week for 12 weeks. Adherence was automatically tracked through the Spring Forest Qigong website. Outcomes of neuropathic pain intensity (NPRS) were assessed weekly, and SCI-related symptoms were assessed at baseline, 6, and 12 weeks of Qigong practice and at 6-week and 1-year follow-ups. Results: We recruited 23 adults with chronic SCI (7/2021-2/2023). In total, 18 participants started the study and completed all study components, including the 6-week follow-up. Twelve participants completed the 1-year follow-up assessment. Feasibility was demonstrated through participants' willingness to participate, adherence, and acceptability of the study. Mean age of the 18 participants was 60 ± 12 years, and they were 15 ± 11 years post-SCI with the highest baseline neuropathic pain of 7.94 ± 2.33, which was reduced to 4.17 ± 3.07 after 12 weeks of Qigong practice (Cohen's d = 1.75). This pain relief remained at 6-week and 1-year follow-ups. Participants reported reduced spasm frequency (change score 1.17 ± 1.20, d = 0.98) and severity (0.72 ± 1.02, d = 0.71), reduced interference of neuropathic pain on mood (3.44 ± 2.53, d = 1.36), sleep (3.39 ± 2.40, d = 1.41), daily activities (3.17 ± 2.77, d = 1.14), greater ability to perform functional activities (6.68 ± 3.07, d = 2.18), and improved mood (2.33 ± 3.31, d = 0.70) after Qigong. Discussion: Remote Spring Forest Qigong's "Five Element Qigong Healing Movements" practice is feasible in adults with SCI-related neuropathic pain, with promising prolonged results of neuropathic pain relief and improvement in SCI-related symptoms after Qigong practice. Clinical trial registration: https://www.clinicaltrials.gov/ct2/show/NCT04917107, identifier NCT04917107.
[Study on acupuncture and moxibustion for treatment of spinal cord injury at the rehabilitation stage]. [2007]To explore the mechanism and methods of acupuncture for the patient of spinal cord injury at the stage of rehabilitation.
Scalp Acupuncture for the Treatment of Motor Function in Acute Spinal Cord Injury: A Case Report. [2018]An acute spinal cord injury is the result of a traumatic injury to the spinal cord caused by a contusion, compression, or severing of the spinal cord. There are approximately 17,000 new cases each year, of which, males account for 80%. Approximately 65% of these injuries cause incomplete or partial damage to the spinal cord. Comprehensive treatment is essential to restore maximum function. Surgical procedures, stem cell therapy, pharmaceutical agents, and physical therapy are employed to minimize and repair damage done to the nervous system. The majority of motor and sensory recovery occurs during the first 12 to 15 weeks after the injury. Acupuncture has shown promising results in mediating neural plasticity and could be a useful treatment modality in hospital and rehabilitation settings. This case presents the treatment of an acute spinal cord injury, level T5, incomplete, with scalp acupuncture both within and beyond the optimal recovery window. The treatments given within the optimal window seemed to facilitate better restoration of nervous system communication when performing specific action.