Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain

NCT ID: NCT04164225

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Qigong

Qigong exercises, focused on a mind-body connection

Group Type EXPERIMENTAL

Qigong Exercise

Intervention Type BEHAVIORAL

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.

P.Volve

P.Volve exercises, focused on just physical movement

Group Type ACTIVE_COMPARATOR

P.Volve Exercises

Intervention Type BEHAVIORAL

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, while other exercises are done with no equipment. Tailored videos will be available for those with cLBP. 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.

Interventions

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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.

Intervention Type 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, while other exercises are done with no equipment. Tailored videos will be available for those with cLBP. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Van de Winckel, PhD,MSPT,PT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minneapolis, MN 55455

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ann Van de Winckel, PhD, MSPT, PT

Role: CONTACT

612-625-1191

Facility Contacts

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Ann Van de Winckel, PhD, MS, PT

Role: primary

612-625-1191

References

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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 1:2023.02.11.23285808. doi: 10.1101/2023.02.11.23285808.

Reference Type DERIVED
PMID: 36824785 (View on PubMed)

Related Links

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https://www.med.umn.edu/rehabmedicine/research/identifying-qigong-brain-changes

Evaluating the effect and mechanism of Qigong in people with chronic low back pain

Other Identifiers

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PMR-2019-27351

Identifier Type: -

Identifier Source: org_study_id

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