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NCT04164225 · University of Minnesota

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

What this study is about

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.

View original scientific description

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.

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, 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.

Primary outcome measures

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

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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)

Where

  • Minneapolis, Minnesota

Related conditions & keywords

Low Back Pain

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations

📊
1 of 60 participants interested
2% interest

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Study locations

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RECRUITING

Minneapolis

Minnesota

Location available

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Low Back Pain Treatment in Minneapolis?

Join others in Minnesota exploring innovative treatment options through clinical research

Low Back Pain Treatment Options in Minneapolis, Minnesota

If you're searching for Low Back Pain treatment in Minneapolis, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Minneapolis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Low Back Pain. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Minnesota
Now Enrolling
Up to 60 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Low Back Pain?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Low Back Pain

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Low Back Pain Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04164225. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.