Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qigong Exercise, P.Volve Exercises.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain
Overview
The long-term objective of this investigation is to identify how Qigong affects brain function in brain areas relevant to patients with chronic low back pain (cLBP), thereby setting a foundation from which to perform further clinical research.
Detailed description
The central hypothesis of this investigation is that, in adults with cLBP, practicing Qigong compared to exercise will result in reduced pain and improved body awareness and proprioception (primary behavioral endpoints), disability, balance, core muscle strength, and other CLBP symptoms will be secondary behavioral endpoints.To test this hypothesis, the investigators will assess (1) participant recruitment and retention ; (2) adherence to interventions, engagement/satisfaction with the program; and (3) changes in body awareness-related brain activation and connectivity pre-post intervention (Qigong vs exercise) related to primary endpoints of pain perception, body awareness and objective measures of lower limb proprioception.
Interventions
- Behavioral Qigong Exercise
Participants with chronic low back pain will follow the free "5 elements Qigong healing class" (estimate of 6 hours) at the Spring Forest Qigong center and then practice the "5 elements healing Qigong" at home 3 times a week for 40 minutes with a freely available online video, for 12 weeks. A weekly group session (1 hour) will be conducted at the Brain Body Mind Lab with the principal investigator to address questions and demonstrate movements if needed. - Behavioral P.Volve Exercises
P.Volve exercise focuses on low impact core strengthening, core stabilization, and stretching. The program is similar in delivery as Qigong (i.e., online videos). An introductory class (estimate of 2.5h) will be given by the P.Volve team, the principal investigator, and a physical therapist who has experience with P.Volve exercises. Participants will access online videos for individual home practice in 40min/session, 3x/week for 12 weeks. Participants will receive a P.ball for some exercises, wh
Primary outcome measures
- Change in Pain Numeric Rating Scale (NRS) [Time frame: baseline, 15 weeks]
- Change in Revised Body Awareness Rating Questionnaire (BARQ) [Time frame: baseline, 15 weeks]
- Change in Mindfulness Attention Awareness Scale (MAAS) [Time frame: baseline, 15 weeks]
- Change in Five-Facet Mindfulness Questionnaire (FFMQ) [Time frame: baseline, 15 weeks]
- Change in Proprioception [Time frame: baseline, 15 weeks]
- Change in Postural Awareness Scale (PAS) [Time frame: baseline, 15 weeks]
Secondary outcome measures (8)
- Change in Modified Roland Morris Disability Questionnaire [Time frame: baseline, 15 weeks]
- Change in Fear-Avoidance Beliefs Questionnaire (FABQ) [Time frame: baseline, 15 weeks]
- Change in Pain Self-Efficacy questionnaire (PSEQ) [Time frame: baseline, 15 weeks]
- Change in Tampa Scale for Kinesiophobia [Time frame: baseline, 15 weeks]
- Change in Core Muscle Stabilization - Prone [Time frame: baseline, 15 weeks]
- Change in Core Muscle Stabilization - Supine [Time frame: baseline, 15 weeks]
- Change in Balance Test - Right Leg [Time frame: baseline, 15 weeks]
- Change in Balance Test - Left Leg [Time frame: baseline, 15 weeks]
Eligibility criteria
Inclusion criteria
\- Adults with chronic low back pain
Exclusion criteria
- Those with cognitive problems
- Those unable to speak or understand instructions
- Those who have nerve problems, fractures, or infections
- Those who do not speak English
- Those with severe deficit in motor imagery or in vision (both are used in MRI tasks)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minn — Minneapolis
Publications
- Van de Winckel A, Zhang L, Hendrickson T, Lim KO, Mueller BA, Philippus A, Monden KR, Oh J, Huang Q, Sertic JVL, Ruen J, Konczak J, Evans R, Bronfort G. Identifying body awareness-related brain network changes after Spring Forest Qigong practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial. medRxiv [Preprint]. 2023 Mar 1:20 PMID 36824785
Identifiers
NCT: NCT04164225 · PMR-2019-27351