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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial will test whether qigong, a mind and body approach that incorporates gentle body movements, paired with a focus on breathing and body awareness to promote health and wellness, can reduce SCI-related neuropathic pain.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Numeric Pain Rating Scale (NPRS)
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,445 Total Patients Enrolled
Ann Van de Winckel, PhD, MSPT, PTPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
67 Total Patients Enrolled

Media Library

Qigong (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04917107 — N/A
Spinal Cord Injury Research Study Groups: Qigong First, Observation First
Spinal Cord Injury Clinical Trial 2023: Qigong Highlights & Side Effects. Trial Name: NCT04917107 — N/A
Qigong (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04917107 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of participant involvement in this experiment?

"Correct. Information hosted on clinicaltrials.gov suggests that this medical investigation, which was initially advertised on July 1st 2021, is actively enrolling people in its experiment. Approximately 64 subjects need to be recruited from a single site."

Answered by AI

Are there any available openings for participants in this research?

"Affirmative. According to clinicaltrials.gov, this trial is presently looking for participants with the first posting date on July 1st 2021 and most recent edit on August 30th 2022. This medical experiment requires 64 people from a single site to join in its research efforts."

Answered by AI

What demographic of individuals is eligible to participate in this clinical investigation?

"This trial is recruiting for 64 individuals who have sustained a spinal cord injury and are between the ages of 18-75. Most importantly, participants must report an intensity of greater than 3 on the numeric pain rating scale in relation to their SCI-related neuropathic pain."

Answered by AI

Does this medical experiment welcome geriatric participants?

"The age range for those wishing to join this trial is 18-75. For younger and older participants, there are 145 clinical trials available targeting minors and 863 studies accommodating seniors respectively."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~27 spots leftby Jun 2026