Qigong Exercise for Chronic Low Back Pain

Overseen By Ann Van de Winckel, PhD, MSPT, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Cognitive problems, Nerve problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Qigong exercises impact brain function in people with chronic low back pain. It compares two types of exercises: Qigong, which connects the mind and body, and P.Volve, which focuses on physical movement. The goal is to determine if these exercises can improve brain areas linked to low back pain. The trial seeks adults who have been dealing with chronic low back pain. As an unphased trial, it offers a unique opportunity to contribute to understanding alternative pain management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these exercises are safe for chronic low back pain?

Research has shown that Qigong exercises are generally safe for individuals with long-term low back pain. Many studies indicate that Qigong and similar exercises rarely cause serious side effects, making them a safe option for managing pain and improving movement.

Research also shows that P.Volve exercises are safe and effective. These exercises help individuals regain strength and mobility, particularly after injuries. Designed to be low-intensity, they focus on gentle movements that can relieve back pain.

Both Qigong and P.Volve have proven to be well-tolerated by those managing chronic low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Qigong exercises for chronic low back pain because they emphasize a mind-body connection, which is a unique approach compared to the typical focus on physical treatments like pain medications or physical therapy. Unlike standard treatments that often rely on medication or passive therapies, Qigong integrates mindful movements and breathing techniques that may enhance both mental and physical well-being. This holistic approach could offer a new way to manage pain, potentially reducing the need for medication and improving overall quality of life. Additionally, the inclusion of P.Volve exercises as a comparator focuses solely on physical movement, providing a contrast that might highlight the unique benefits of the mind-body connection in pain management.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

Research shows that Qigong exercises, one of the treatments in this trial, can help people with chronic low back pain. Studies have found that Qigong greatly reduces pain and improves mobility. For example, a review of several studies found that people who practiced Qigong experienced significantly less pain than those who did not. Another study found small to moderate improvements in both pain and disability for those practicing Qigong. Overall, these findings suggest that Qigong could be a good option for managing chronic low back pain. Participants in this trial may also receive P.Volve exercises, which focus on physical movement, as an active comparator. ^{6 7 8 9 10}

Who Is on the Research Team?

Ann Van de Winckel, PhD, MS, PT

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults who have been experiencing chronic low back pain. Participants must be able to understand and follow instructions in English, and should not have severe vision or motor imagery deficits (as they'll need these for MRI tasks), cognitive issues, nerve problems, fractures, or infections.

Inclusion Criteria

I have had low back pain for a long time.

Exclusion Criteria

You have trouble with your memory or thinking.

I have nerve issues, fractures, or infections.

You have a severe problem with imagining movements or seeing clearly, which are needed for MRI tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants practice Qigong or P.Volve exercises to assess changes in brain function and behavioral outcomes

15 weeks

Regular sessions (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• P.Volve Exercises
• Qigong Exercise

Trial Overview

The study is examining how Qigong exercise affects brain function related to chronic low back pain by comparing it with P.Volve exercises. It aims to lay the groundwork for future research by mapping out brain mechanisms involved with Qigong practice outcomes.

How Is the Trial Designed?

Group I: Qigong Experimental Treatment 1 Intervention

Qigong exercises, focused on a mind-body connection

Group II: P.Volve Active Control 1 Intervention

P.Volve exercises, focused on just physical movement

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a randomized controlled trial involving 127 German outpatients with chronic low back pain, qigong was not found to be statistically non-inferior to exercise therapy after 3 months, with pain intensity scores of 34.8 mm for qigong and 33.1 mm for exercise.

Both qigong and exercise therapy had similar rates of reported adverse reactions, indicating that both interventions are relatively safe, but further research is needed to explore qigong's potential role in preventing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qigong versus exercise therapy for chronic low back pain in adults--a randomized controlled non-inferiority trial. Blödt, S., Pach, D., Kaster, T., et al.[2022]

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

This systematic review aims to comprehensively analyze existing systematic reviews on the adverse events associated with Qigong and related therapies, highlighting the need for better understanding of their safety.

The findings will provide valuable insights for clinicians, practitioners, and patients regarding the safe application of Qigong in clinical and daily life settings, while also guiding future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Qigong: Protocol for an overview of systematic reviews. Guo, Y., Xu, MM., Huang, Y., et al.[2022]

A systematic review of 47 trials involving 3877 participants found that Baduanjin exercise is generally safe, with only two studies reporting adverse events such as muscle ache, palpitation, and dizziness.

Despite the low incidence of reported adverse events, the review highlights the need for better monitoring protocols in future studies to ensure comprehensive safety assessments of Baduanjin exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Baduanjin Exercise: A Systematic Review. Fang, J., Zhang, L., Wu, F., et al.[2022]

Internal qigong significantly reduced chronic pain compared to control groups, with a notable effect size of -1.23, indicating its potential as an effective treatment option.

External qigong showed some benefits but did not consistently outperform control or waiting list groups, suggesting that more rigorous studies are needed to confirm its efficacy in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Qigong for Adults with Chronic Pain: Systematic Review and Meta-Analysis. Bai, Z., Guan, Z., Fan, Y., et al.[2022]

Mindful exercises, particularly Tai Chi and Qigong, significantly reduce pain intensity and disability in adults with chronic low back pain (CLBP), with Tai Chi showing the most substantial effect (SMD = -0.75).

The review included 17 randomized controlled trials, indicating that while mindful exercises are generally safe, Yoga was associated with some adverse events, highlighting the importance of training under certified instructors for safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Mindful Exercises Safe and Beneficial for Treating Chronic Lower Back Pain? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Zou, L., Zhang, Y., Yang, L., et al.[2020]

Qigong, a meditative movement practice, has various health benefits that can be understood through its mechanisms of action, including relaxation, energy stimulation, and physical improvements like flexibility and strength.

The study analyzed specific Qigong exercises to identify their meditative, energetic, and physical effects, which can help in defining Qigong more clearly and improving its integration into healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditative Movement, Energetic, and Physical Analyses of Three Qigong Exercises: Unification of Eastern and Western Mechanistic Exercise Theory. Klein, P., Picard, G., Baumgarden, J., et al.[2020]

A systematic review of 7 clinical trials, including 4 randomized controlled trials, found insufficient evidence to support the effectiveness of internal qigong as a treatment for various pain conditions.

In comparisons with other treatments, internal qigong did not show significant benefits for low back pain, neck pain, or fibromyalgia, suggesting that it may not be a reliable option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal qigong for pain conditions: a systematic review. Lee, MS., Pittler, MH., Ernst, E.[2018]

Two case studies involving individuals with chronic back pain showed that practicing a daily regimen of 24-Posture Qigong led to significant symptomatic relief and improved function.

The positive outcomes from Qigong practice may be linked to reduced inflammation and structural restoration, suggesting a need for further controlled studies to explore its efficacy in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qigong and a Tale of Two Back Complaints. Baumgarden, J., Klein, P., Picard, G.[2020]

A feasibility study involving 32 adults with chronic low back pain (cLBP) showed that practicing Spring Forest Qigong™ or P.Volve low-intensity exercises for 12 weeks resulted in significant pain relief and high participant satisfaction, with a retention rate of 94%.

Brain imaging indicated that some participants in the Qigong group experienced improved brain function, particularly in areas related to pain processing, suggesting potential neurological benefits from Qigong practice that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Van de Winckel, A., Zhang, L., Hendrickson, T., et al.[2023]

Qigong exercises may serve as a beneficial adjunctive strategy for adults with arthritis, potentially reducing pain and improving quality of life, despite limited research on the topic.

Health professionals can safely recommend Qigong to most adults with arthritis, as it is a low-risk intervention that may enhance well-being and alleviate symptoms associated with the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qigong Exercise and Arthritis. Marks, R.[2020]

A 12-week Zhineng Qigong intervention for 52 patients with chronic low back pain showed significant improvements in pain levels, disability, and health-related quality of life, indicating its potential efficacy as a treatment option.

Despite a low recruitment rate of 11%, the study successfully demonstrated that patients, including those with chronic pain post-lumbar surgery, experienced meaningful benefits, suggesting the need for further research in a larger, multicenter randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and function in patients with chronic low back pain and leg pain after Zhineng Qigong - a quasi-experimental feasibility study. Pozarek, G., Strömqvist, B., Ekvall Hansson, E., et al.[2023]

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This study aimed to compare the long-term effects of flexion- and extension-based lumbar exercises on chronic axial low back pain (LBP).

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