TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-01
Study Completion:2023-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04917107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Spinal cord injury of greater than or equal to 3 months
  2. * Medically stable with paraplegia (T1 and below) or tetraplegia (C4 and below)
  3. * Highest level of below-level SCI-related neuropathic pain \>3 on the numeric pain rating scale.
  1. * MRI contra-indications (stabilizing hardware is typically MRI safe)
  2. * 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
  3. * Ventilator dependency
  4. * Pregnancy to plans to become pregnant during study
  5. * Inability to perform kinesthetic imagery.
  6. * 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.

Contacts and Locations

Principal Investigator

Ann Van de Winckel, PhD, MSPT, PT
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Ann Van de Winckel, PhD, MSPT, PT, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2023-02-01

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2023-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries