CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults With Spinal Cord Injury

NCT04917107 | Terminated

• 1 other identifier: STUDY00011997
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (7)

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

  24 weeks

• Change in WHOQOL-BREF

  24 weeks

• Change in The Revised Body Awareness Rating Questionnaire (BARQ)

  24 weeks

• Change in The Moorong Self-Efficacy Scale (MSES)

  24 weeks

• Change in The Tampa Scale for Kinesiophobia (TSK)

  24 weeks

Study Arms (2)

Qigong First

EXPERIMENTAL

Participants in this group will complete the 12-week Qigong intervention first and then the 12-week observation period.

Behavioral: Qigong

Observation First

EXPERIMENTAL

Participants in this group will complete the 12-week observation period first and then the 12-week Qigong intervention.

Behavioral: Qigong

Interventions

Qigong BEHAVIORAL

The "Five Element Qigong Healing Movements" practice includes five gentle horizontal and vertical arm and leg movements performed with guided breathing.

Observation First; Qigong First

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

• 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.

  PMID: 37719467 DERIVED

• Van 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.

  PMID: 37608389 DERIVED

• Van 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.

  PMID: 36824929 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Qigong

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ann Van de Winckel, PhD, MSPT, PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Delayed design

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: July 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)