What side effects are associated with this type of intervention?

Mind-body approaches and gentle movement therapies, such as Qigong, Tai Chi, and yoga, are generally considered safe for patients with Spinal Cord Injury (SCI). Common side effects are minimal but can include mild muscle soreness, fatigue, and, in rare cases, dizziness or lightheadedness. These therapies focus on gentle movements, breathing, and body awareness, which typically do not pose significant risks. However, it is essential for patients to perform these exercises under the guidance of a trained professional to avoid any potential strain or injury.

What prior FDA approvals exist?

There are no specific FDA-approved drugs that directly align with the mind and body approach of Qigong for the treatment of Spinal Cord Injury (SCI). Traditional FDA-approved treatments for SCI typically focus on managing symptoms and complications through medications such as corticosteroids to reduce inflammation, and other drugs to manage pain, spasticity, and secondary conditions. Rehabilitation therapies, including physical and occupational therapy, are commonly used to improve functional outcomes. While Qigong and similar mind-body practices are being studied for their potential benefits in SCI, they are generally considered complementary therapies rather than primary FDA-approved treatments.

What other types of research exist?

Promising novel alternatives to Qigong for SCI patients include: 1) Tai Chi, which has been shown to improve balance and reduce fall risk in neurological disorders; 2) Yoga, which can enhance functional ability, pain management, and psychosocial outcomes; 3) Mindfulness-Based Stress Reduction (MBSR), which helps in pain management and improving the stress response; and 4) Progressive Muscle Relaxation (PMR), which has been effective in reducing pain and improving quality of life in various patient populations.

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Behavioral Intervention

Qigong for Spinal Cord Injury

N/A

Recruiting

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

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spinal cord injury of greater than or equal to 3 months

Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Qigong is generally considered safe but may include mild side effects like muscle soreness or strain from new physical activities. Since it's also a mental exercise focusing on relaxation and breathing, some might experience emotional discomfort or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have stable paraplegia or tetraplegia.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Numeric Pain Rating Scale (NPRS)

Secondary study objectives

Change in The Moorong Self-Efficacy Scale (MSES)

Change in The Patient Health Questionnaire-9 (PHQ-9)

Change in The Revised Body Awareness Rating Questionnaire (BARQ)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Qigong

2010

Completed Phase 3

~1120

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) include physical rehabilitation therapies and mind-body approaches like Qigong. These treatments work by promoting neuroplasticity, improving muscle strength, and enhancing functional mobility. Qigong, for example, combines gentle movements, focused breathing, and body awareness to reduce neuropathic pain and improve overall well-being. These mechanisms are crucial for SCI patients as they help mitigate pain, enhance physical function, and improve quality of life, thereby supporting better rehabilitation outcomes.

An assessment of the contribution of electromyographic biofeedback as an adjunct therapy in the physical training of spinal cord injured persons.