Low Back PainNCT04164225
Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain
A study testing Qigong Exercise and P.Volve Exercises in people with Low Back Pain, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Qigong Exercise and P.Volve Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with chronic low back pain
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minneapolis, MN 55455
Minneapolis, Minnesota, 55455
Ann Van de Winckel, PhD, MS, PT, 612-625-1191, avandewi@umn.edu
About this study
Official title: Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Qigong Exercise, P.Volve Exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong ExerciseBehavioural
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 ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | Qigong exercises, focused on a mind-body connection Receives: Behavioral: Qigong Exercise |
| P.Volve | Active comparator | P.Volve exercises, focused on just physical movement Receives: Behavioral: P.Volve Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, 15 weeks
Secondary outcomes (8)
Change in Modified Roland Morris Disability Questionnaire
The Modified Roland Morris Disability Questionnaire, designed to assess self-rated physical disability caused by low back pain, contains 23 items. Items are scored 0 (no) or 1 (yes). Total scores are calculated as a sum with higher scores indicated greater physical disability caused by low back pain.
Measured: baseline, 15 weeks
Change in Fear-Avoidance Beliefs Questionnaire (FABQ)
The Fear-Avoidance Beliefs Questionnaire (FABQ), a patient-reported questionnaire focusing on how a patient's fear of physical activity and work may affect their low back pain and disability, contains 16 items rated on a 7-point Likert from 0 (completely disagree) to 6 (completely agree). Total scores are calculated as a sum with a maximum score of 96. Higher scores indicated more strongly-hold fear avoidance beliefs.
Measured: baseline, 15 weeks
Change in Pain Self-Efficacy questionnaire (PSEQ)
The Pain Self-Efficacy questionnaire (PSEQ) is a 10-item questionnaire measuring a patient's confidence in their ability to complete a task despite pain. Items are rated on a scale from 0 (not at all confident) to 6 (completely confident). Total scores are a sum of the 10 items scores with a maximum score of 60. Lower scores indicate greater pain-related disability.
Measured: baseline, 15 weeks
Change in Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a 17-item questionnaire measuring fear related to exercise and movement. Items are rated on a scale of 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing the individual item scores after inversion of the individual scores for items 4, 8, 12 and 16. Higher scores indicated greater kinesiophobia.
Measured: baseline, 15 weeks
Change in Core Muscle Stabilization - Prone
Participants are asked to perform a prone bridge position. The length of time the position is held is recorded in seconds.
Measured: baseline, 15 weeks
Change in Core Muscle Stabilization - Supine
Participants are asked to perform a supine bridge position. The length of time the position is held is recorded in seconds.
Measured: baseline, 15 weeks
Change in Balance Test - Right Leg
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Measured: baseline, 15 weeks
Change in Balance Test - Left Leg
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Measured: baseline, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start21 Jan 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Van de Winckel, PhD,MSPT,PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164225
- Sponsor's protocol ID
- PMR-2019-27351
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 1:2023.02.11.23285808. doi: 10.1101/2023.02.11.23285808.
PubMed 36824785
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04164225
- Acronym / sponsor ID
- PMR-2019-27351
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: Qigong ExerciseQigong exercises, focused on a mind-body connection |
| P.Volve | Active comparator | Behavioral: P.Volve ExercisesP.Volve exercises, focused on just physical movement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with chronic low back pain
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qigong ExerciseParticipants 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. | Behavioural | Qigong |
| P.Volve ExercisesP.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. | Behavioural | P.Volve |
Primary outcome
Change in Pain Numeric Rating Scale (NRS)
Time frame: baseline, 15 weeks
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.
Change in Revised Body Awareness Rating Questionnaire (BARQ)
Time frame: baseline, 15 weeks
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.
Change in Mindfulness Attention Awareness Scale (MAAS)
Time frame: baseline, 15 weeks
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.
Change in Five-Facet Mindfulness Questionnaire (FFMQ)
Time frame: baseline, 15 weeks
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.
Change in Proprioception
Time frame: baseline, 15 weeks
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.
Change in Postural Awareness Scale (PAS)
Time frame: baseline, 15 weeks
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 36824785Van 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.
- Evaluating the effect and mechanism of Qigong in people with chronic low back painLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann Van de Winckel, PhD,MSPT,PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong Exercise and P.Volve Exercises in people with Low Back Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Van de Winckel, PhD, MSPT, PT (612-625-1191, avdwlab@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Numeric Rating Scale (NRS) (time frame: baseline, 15 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.