Spinal Cord InjuriesNCT04917107
CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults With Spinal Cord Injury
A study testing Qigong in people with Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
Trial summary
Between 39-67% of the 294,000 Americans who have a SCI suffer from long-term debilitating neuropathic pain, interfering with rehabilitation, general activity, mobility, mood, sleep, and quality of life. Pain can hinder any potential for functional improvement that could be obtained during rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury of greater than or equal to 3 months
- Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
- Highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Who cannot join
- MRI contra-indications (stabilizing hardware is typically MRI safe)
- 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
- Ventilator dependency
- Pregnancy to plans to become pregnant during study
- Inability to perform kinesthetic imagery.
- Participants who cannot feel index finger movements will not perform the robot task but will perform all other resting-state and tasks in the MRI scanner.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Between 39-67% of the 294,000 Americans who have a SCI suffer from long-term debilitating neuropathic pain, interfering with rehabilitation, general activity, mobility, mood, sleep, and quality of life. Pain can hinder any potential for functional improvement that could be obtained during rehabilitation. Yet, neuropathic pain is refractory to many treatments. Current interventions, such as medications and physical therapy, result in less than 50% reduction in pain for only about one third of the people trying them, calling for new treatment options.
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, could reduce SCI-related neuropathic pain. If the hypothesis is supported, the resulting work could be transformative in demonstrating a potentially effective therapy for civilians, military Service members, and Veterans with SCI and neuropathic pain. The following provides the scientific basis for this hypothesis and establishes the rationale for this approach.
This study also includes an optional, remote, quasi-experimental substudy, in which all participants will receive Qigong for 12 weeks, followed by 6 weeks followup.
Read the detailed description
Neuropathic pain in adults with spinal cord injury (SCI) has been attributed to altered pain processing-related brain function. However, recent studies showed that SCI-related brain alterations impact more than pain perception alone, because adults with SCI also have altered body awareness. As suggested by previous brain imaging studies, SCI-related neuropathic pain could be viewed as part of a broader body awareness deficit, affecting connectivity with two brain areas -the parietal operculum (parts OP1/OP4) and the insula- which are essential for the formation of body awareness as well as for pain perception. Previous data imply that improving body awareness could restore the altered pain pathways and lead to neuropathic pain relief. However, for SCI, restoring the pain pathways and relieving neuropathic pain through body awareness training have been a challenge in the rehabilitation field. In this proposal, the investigators will test the hypothesis that 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- could reduce SCI-related neuropathic pain by improving body awareness. Enhancing body awareness may also be beneficial for adults with "discomplete" SCI, characterized by complete transection as judged by clinical criteria, but with neurophysiological evidence of conduction through the level of damage.
The central hypothesis is that Qigong restores body awareness and sensory and pain perception processing through restoring OP1/OP4 and insula connectivity, thereby reducing or relieving pain. It is further hypothesized that Qigong practice is feasible and safe for adults with SCI and that kinesthetic imagery of Qigong movements (for those unable to perform arm movements) versus performing the movements will have the same effect on brain function in key pain areas, and on reducing pain. If these hypotheses are supported, the outcomes could be transformative in (i) showing a potentially effective therapy for neuropathic pain relief that can be done at home, (ii) delineating underlying neural mechanisms of how Qigong relieves neuropathic pain, and (iii) demonstrating that body awareness training can improve signal conduction in discomplete SCI.
Specific Aim 1: Determine whether 12 weeks of Qigong is feasible and well tolerated in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).
Specific Aim 2: Determine whether 12 weeks of Qigong practice reduces moderate to severe below-level neuropathic pain in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).
Specific Aim 3: Determine whether 12 weeks of Qigong practice restores brain activity and connectivity related to pain processing in adults with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- Qigong
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongBehavioural
The "Five Element Qigong Healing Movements" practice includes five gentle horizontal and vertical arm and leg movements performed with guided breathing.
| Study group | Role | What they receive |
|---|---|---|
| Qigong First | Experimental | Participants in this group will complete the 12-week Qigong intervention first and then the 12-week observation period. Receives: Behavioral: Qigong |
| Observation First | Experimental | Participants in this group will complete the 12-week observation period first and then the 12-week Qigong intervention. Receives: Behavioral: Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Pain is rated on a scale of 0-10, with higher scores indicating greater pain intensity. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Secondary outcomes (7)
Change in The Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-report questionnaire, which assesses the presence and intensity of depressive symptoms. There are 9 items scored from 0 to 3 based on the frequency of occurrence in the past two weeks (0= not at all, 1=several days, 2=more than half the days, 3= nearly every day) and a single question that rates how difficult these problems have made it to do work, take care of things at home, or get along with others. Total score is a sum of all items scores, ranging between 0 and 27, with higher scores indicating more severe depression (5-9 Minimal Symptoms, 10-14 Moderate depression, 15-20 Moderately Severe depression, >20 Severe depression). Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in WHOQOL-BREF
The World Health Organization Quality of Life Instruments( WHOQOL- BREF) assesses quality of life within the context of an individual's culture, value systems, personal goals, standards and concerns in the last two weeks. Questionnaire contains 26 items assessing 4 quality domains of quality of life (QOL): physical health (7 items), psychological health (6 items), social relationships (3 items) and environmental (8 items). In addition, two other items measure overall QOL and general health.
Items are rated on a 5-point Likert scale to determine a raw item score. The mean score of items within each domain is used to calculate the domain score. After scores are computed, they transformed linearly to a 0-100 scale. Higher scores indicate a higher quality of life. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in The Revised Body Awareness Rating Questionnaire (BARQ)
The Body Awareness Rating Questionnaire (BARQ) is a self-report questionnaire designed to capture how individuals with long-lasting musculoskeletal pain reflect on their own body awareness. This questionnaire contains 12 items rated on a scale from 0 (completely disagree) to 3 (completely agree). The total score is a sum of all items and ranges from 0 to 36, with lower scores indicating higher body awareness. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in The Moorong Self-Efficacy Scale (MSES)
The Moorong Self-Efficacy Scale contains 16 items rated on a 7-point Likert scale from 1 (very uncertain) to 7 (very certain). Totals score is calculated as a sum of the 16 items scores. Total scores range from 16 to 112, with higher scores reflecting high self efficacy. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in The Tampa Scale for Kinesiophobia (TSK)
The TSK assesses fear of injury due to physical movement. Respondents rate 17 items on a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Items include statements such as "I wouldn't have this much pain if there weren't something potentially dangerous going on in my body" and "I can't do all the things normal people do because it's too easy for me to get injured." Responses are summed to create a total score ranging between 17 to 68, where higher scores indicate an increasing degree of kinesiophobia. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in the Physical Activity Enjoyment Scale (PACES)
The Physical Activity Enjoyment Scale contains 18 items that are rated on a 7-point scale. 11 items are scored in reverse order. Total scores range from 18 to 126, with higher scores indicating greater level of enjoyment. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Change in the Sydney Psychosocial Reintegration Scale (SPRS)
The SPRS is a 12 item questionnaire that assess community integration. Items are rated from 0 (equivalent to "an extreme amount of change" on Form A or "extremely poor" on Form B) to 4 (equivalent to "no change at all" on form A or "very good" on form B). The total score ranges from 0 to 48 (0-16 for each domain), with higher scores representing greater levels of psychosocial reintegration. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: Never received funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Delayed design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD, MSPT, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917107
- Sponsor's protocol ID
- STUDY00011997
- Status last verified
- Sep 2025
- First submitted
- 1 Jun 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van de Winckel A, Carpentier ST, Deng W, Zhang L, Philippus A, Battaglino R, Morse LR. Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study. Front Physiol. 2023 Aug 31;14:1222616. doi: 10.3389/fphys.2023.1222616. eCollection 2023.
PubMed 37719467Van de Winckel A, Carpentier S, Deng W, Zhang L, Battaglino R, Morse L. Using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial. Pilot Feasibility Stud. 2023 Aug 22;9(1):145. doi: 10.1186/s40814-023-01374-3.
PubMed 37608389Van de Winckel A, Carpentier ST, Deng W, Zhang L, Philippus A, Monden KR, Battaglino R, Morse LR. Using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial. medRxiv [Preprint]. 2023 Feb 15:2023.02.11.23285793. doi: 10.1101/2023.02.11.23285793.
PubMed 36824929
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04917107
- Acronym / sponsor ID
- STUDY00011997
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Never received funding
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Between 39-67% of the 294,000 Americans who have a SCI suffer from long-term debilitating neuropathic pain, interfering with rehabilitation, general activity, mobility, mood, sleep, and quality of life. Pain can hinder any potential for functional improvement that could be obtained during rehabilitation. Yet, neuropathic pain is refractory to many treatments. Current interventions, such as medications and physical therapy, result in less than 50% reduction in pain for only about one third of the people trying them, calling for new treatment options.
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, could reduce SCI-related neuropathic pain. If the hypothesis is supported, the resulting work could be transformative in demonstrating a potentially effective therapy for civilians, military Service members, and Veterans with SCI and neuropathic pain. The following provides the scientific basis for this hypothesis and establishes the rationale for this approach.
This study also includes an optional, remote, quasi-experimental substudy, in which all participants will receive Qigong for 12 weeks, followed by 6 weeks followup.
Detailed description
Neuropathic pain in adults with spinal cord injury (SCI) has been attributed to altered pain processing-related brain function. However, recent studies showed that SCI-related brain alterations impact more than pain perception alone, because adults with SCI also have altered body awareness. As suggested by previous brain imaging studies, SCI-related neuropathic pain could be viewed as part of a broader body awareness deficit, affecting connectivity with two brain areas -the parietal operculum (parts OP1/OP4) and the insula- which are essential for the formation of body awareness as well as for pain perception. Previous data imply that improving body awareness could restore the altered pain pathways and lead to neuropathic pain relief. However, for SCI, restoring the pain pathways and relieving neuropathic pain through body awareness training have been a challenge in the rehabilitation field. In this proposal, the investigators will test the hypothesis that 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- could reduce SCI-related neuropathic pain by improving body awareness. Enhancing body awareness may also be beneficial for adults with "discomplete" SCI, characterized by complete transection as judged by clinical criteria, but with neurophysiological evidence of conduction through the level of damage.
The central hypothesis is that Qigong restores body awareness and sensory and pain perception processing through restoring OP1/OP4 and insula connectivity, thereby reducing or relieving pain. It is further hypothesized that Qigong practice is feasible and safe for adults with SCI and that kinesthetic imagery of Qigong movements (for those unable to perform arm movements) versus performing the movements will have the same effect on brain function in key pain areas, and on reducing pain. If these hypotheses are supported, the outcomes could be transformative in (i) showing a potentially effective therapy for neuropathic pain relief that can be done at home, (ii) delineating underlying neural mechanisms of how Qigong relieves neuropathic pain, and (iii) demonstrating that body awareness training can improve signal conduction in discomplete SCI.
Specific Aim 1: Determine whether 12 weeks of Qigong is feasible and well tolerated in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).
Specific Aim 2: Determine whether 12 weeks of Qigong practice reduces moderate to severe below-level neuropathic pain in 64 individuals with SCI with either paraplegia (n=32) or tetraplegia (n=32).
Specific Aim 3: Determine whether 12 weeks of Qigong practice restores brain activity and connectivity related to pain processing in adults with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Delayed design
| Arm | Type | Receives |
|---|---|---|
| Qigong First | Experimental | Behavioral: QigongParticipants in this group will complete the 12-week Qigong intervention first and then the 12-week observation period. |
| Observation First | Experimental | Behavioral: QigongParticipants in this group will complete the 12-week observation period first and then the 12-week Qigong intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Spinal cord injury of greater than or equal to 3 months
- Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
- Highest level of below-level SCI-related neuropathic pain >3 on the numeric pain rating scale.
Key exclusion criteria (6 listed)
- MRI contra-indications (stabilizing hardware is typically MRI safe)
- 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
- Ventilator dependency
- Pregnancy to plans to become pregnant during study
- Inability to perform kinesthetic imagery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QigongThe "Five Element Qigong Healing Movements" practice includes five gentle horizontal and vertical arm and leg movements performed with guided breathing. | Behavioural | Observation First, Qigong First |
Primary outcome
Change in Numeric Pain Rating Scale (NPRS)
Time frame: 24 weeks
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Pain is rated on a scale of 0-10, with higher scores indicating greater pain intensity. Outcome is measured at baseline, following 12 weeks of observation, and following 12 weeks of Qigong intervention.
7 secondary outcomes
Change in The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 24 weeks
Change in WHOQOL-BREF
Time frame: 24 weeks
Change in The Revised Body Awareness Rating Questionnaire (BARQ)
Time frame: 24 weeks
Change in The Moorong Self-Efficacy Scale (MSES)
Time frame: 24 weeks
Change in The Tampa Scale for Kinesiophobia (TSK)
Time frame: 24 weeks
Change in the Physical Activity Enjoyment Scale (PACES)
Time frame: 24 weeks
Change in the Sydney Psychosocial Reintegration Scale (SPRS)
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Never received funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 37719467Van de Winckel A, Carpentier ST, Deng W, Zhang L, Philippus A, Battaglino R, Morse LR. Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study. Front Physiol. 2023 Aug 31;14:1222616. doi: 10.3389/fphys.2023.1222616. eCollection 2023.
- Derived from this study: PubMed 37608389Van de Winckel A, Carpentier S, Deng W, Zhang L, Battaglino R, Morse L. Using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: protocol of a quasi-experimental feasibility clinical trial. Pilot Feasibility Stud. 2023 Aug 22;9(1):145. doi: 10.1186/s40814-023-01374-3.
- Derived from this study: PubMed 36824929Van de Winckel A, Carpentier ST, Deng W, Zhang L, Philippus A, Monden KR, Battaglino R, Morse LR. Using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial. medRxiv [Preprint]. 2023 Feb 15:2023.02.11.23285793. doi: 10.1101/2023.02.11.23285793.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Van de Winckel, PhD, MSPT, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong in people with Spinal Cord Injuries, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Never received funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (NPRS) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917107, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.