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

NCT04164225 | Recruiting DMC

• 1 other identifier: PMR-2019-27351
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (6)

• Change in Pain Numeric Rating Scale (NRS)

  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.

  baseline, 15 weeks

• Change in 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. Lower scores indicate greater body awareness.

  baseline, 15 weeks

• Change in Mindfulness Attention Awareness Scale (MAAS)

  The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness. Items are rated on a scale from 1 (almost always) to 6 (almost never). The total score is an unweighted mean of the 15 item scores.

  baseline, 15 weeks

• Change in Five-Facet Mindfulness Questionnaire (FFMQ)

  The FFMQ is a 39-item scale measuring five facets of mindfulness: observing (items 1, 6, 11, 15, 20, 26, 31, and 36), describing (items 2, 7, 12R, 16R, 22R, 27, 32, and 37), acting with awareness (items 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R), non-judging of inner experience (items 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R), and non-reactivity to inner experience (items 4, 9, 19, 21, 24, 33). Items are rated on a scale from 1 (never or very rarely true) to 5 (very often or always true). Items marked with "R" are scored in reverse. Sub scale and total scale scores can be calculated by sum or unweighted mean. Higher scores indicate higher levels of mindfulness.

  baseline, 15 weeks

• Change in Proprioception

  Lower-limb proprioception will be measured by a lower limb device that produces assessment of proprioceptive acuity and sensitivity of the ankle and/or knee joint in the sagittal plane. Output is measured in degrees of joint motion of the ankle and knee.

  baseline, 15 weeks

• Change in Postural Awareness Scale (PAS)

  The PAS is a 12-item scale, which was developed in order to measure self-reported awareness of body posture in patients with chronic pain and to evaluate potential changes in postural awareness induced by a multimodal mind-body training program. Item responses range from 1 (not at all true about me) to 7 (very true about me). Six items are reversely scored, so that higher score values consistently indicate higher postural awareness. Total scores are a sum of items scores and range from 13 to 91, with higher scores indicating greater postural awareness

  baseline, 15 weeks

Secondary Outcomes (8)

• Change in Modified Roland Morris Disability Questionnaire

  baseline, 15 weeks

• Change in Fear-Avoidance Beliefs Questionnaire (FABQ)

  baseline, 15 weeks

• Change in Pain Self-Efficacy questionnaire (PSEQ)

  baseline, 15 weeks

• Change in Tampa Scale for Kinesiophobia

  baseline, 15 weeks

• Change in Core Muscle Stabilization - Prone

  baseline, 15 weeks

Study Arms (2)

Qigong

EXPERIMENTAL

Qigong exercises, focused on a mind-body connection

Behavioral: Qigong Exercise

P.Volve

ACTIVE COMPARATOR

P.Volve exercises, focused on just physical movement

Behavioral: P.Volve Exercises

Interventions

Qigong Exercise 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.

Qigong

P.Volve Exercises 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.

P.Volve

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults with chronic low back pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

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

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36824785 DERIVED

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann Van de Winckel, PhD,MSPT,PT

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Van de Winckel, PhD, MSPT, PT

CONTACT

612-625-1191; avdwlab@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: November 15, 2019
• Study Start: January 21, 2020
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)