Breathwork for Chronic Pain

Overseen By Allison Davis, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Breathwork experience, Severe pain disability

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

Compensation: Varies

Number of Visits: 3

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a two-hour breathwork session, called Guided Respiration Mindfulness Therapy (GRMT), can help reduce chronic musculoskeletal pain. Researchers aim to determine if this focused breathing technique can serve as a useful tool for pain management. Suitable participants have been diagnosed with chronic pain and have not practiced breathwork before. Participants must also understand English instructions and refrain from starting any new treatments during the study.

As an unphased trial, this study offers a unique opportunity to explore innovative pain management techniques.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you do not start any new treatments during the study.

What prior data suggests that this breathwork technique is safe for chronic pain?

Research has shown that Guided Respiration Mindfulness Therapy (GRMT) can reduce stress, anxiety, and overall mental distress. However, specific safety information for this therapy is not available. Generally, breathing exercises like GRMT are considered low-risk when performed correctly, and most people tolerate them well without serious side effects. This is a feasibility trial, aimed primarily at assessing how practical and manageable the treatment is. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic pain, which often involve medications like opioids or NSAIDs, Guided Respiration Mindfulness Therapy (GRMT) offers a non-drug approach. GRMT focuses on using breathing techniques to manage pain, potentially reducing the need for medication and avoiding their side effects. Researchers are excited about GRMT because it empowers patients to manage their pain through mindfulness, offering a holistic alternative that targets both the mind and body. This method could revolutionize how chronic pain is treated by providing a sustainable, self-managed tool for relief.

What evidence suggests that Guided Respiration Mindfulness Therapy might be an effective treatment for chronic pain?

Research has shown that Guided Respiration Mindfulness Therapy (GRMT), which participants in this trial will receive, might help reduce chronic pain. Studies have found that mindfulness-based treatments can lessen the intensity of pain and the distress it causes for people with chronic pain. One study on GRMT reported significant decreases in feelings of distress, anxiety, and stress. This suggests that breathing techniques can improve mental well-being, potentially aiding in chronic pain management. While more research is needed, these early findings are promising for those seeking non-drug ways to relieve pain. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who understand English and have been professionally diagnosed with chronic musculoskeletal pain. Participants should not start any new treatments during the study and must be able to perform basic tasks despite their pain.

Inclusion Criteria

Being able not to commit to another (new) treatment during the course of the study

Understanding English instructions fluently

I have been diagnosed with chronic pain by a healthcare professional.

Exclusion Criteria

Having learned to practice breathwork any time in the past

My pain or its treatment stops me from doing basic tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo a single-session, 2-hour Guided Respiration Mindfulness Therapy training

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain intensity, self-transcendent experiences, and other outcomes

6 weeks

2 visits (in-person) at 2 and 6 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Guided Respiration Mindfulness Therapy (GRMT)

Trial Overview The trial is testing a single-session, two-hour Guided Respiration Mindfulness Therapy (GRMT) training designed to help manage chronic musculoskeletal pain.

How Is the Trial Designed?

Group I: Guided Respiration Mindfulness Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

A new treatment called motivational non-directive (ND) resonance breathing is proposed for chronic widespread pain (CWP), which is challenging to treat due to its unclear causes.

This noninvasive approach aims to enhance five key psychophysiological mechanisms that could help patients manage their pain and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Non-directive Resonance Breathing as a Treatment for Chronic Widespread Pain. Paccione, CE., Jacobsen, HB.[2023]

Mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) both show clinically significant benefits in improving physical functioning and reducing pain intensity in patients with chronic pain, based on a review of 21 studies involving over 1,900 participants.

There was no significant difference in effectiveness between MBSR and CBT, suggesting that both therapies are viable options for managing chronic pain, but further research is needed to standardize measures and guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. Khoo, EL., Small, R., Cheng, W., et al.[2023]

A pilot study involving 29 patients with chronic headaches showed that Mindful-Based Dance Movement Therapy (MBDMT) significantly reduced pain intensity and depression scores compared to a control group, with improvements maintained 16 weeks post-intervention.

The study identified nine therapeutic mechanisms of MBDMT, suggesting it provides a safe environment and promotes mindfulness, body awareness, and self-regulation, making it a promising approach for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of Mindful-Based Dance Movement Therapy Intervention for Chronic Pain: A Pilot Study With Chronic Headache Patients. Majore-Dusele, I., Karkou, V., Millere, I.[2021]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

Music-imaginative Pain Treatment (MIPT) encourages patients to express their pain through music, promoting self-reflection and active engagement, which can be beneficial in managing chronic pain disorders.

In this case study of a 46-year-old woman, early childhood stress was identified as a significant factor influencing her chronic pain, highlighting the importance of addressing psychological and social trauma in pain management therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of music-imaginative pain treatment (MIPT) on psychophysical affect regulation - A single case study. Glomb, S., Böckelmann, I., Frommer, J., et al.[2022]

An eight-week Mindfulness-Based Stress Reduction (MBSR) program showed significant improvements in pain disability, psychological distress, and activity levels among 17 adult patients with chronic pain.

Participants reported a greater willingness to experience pain and lower subjective ratings of current pain, indicating that MBSR can be an effective intervention for managing chronic pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. Beaulac, J., Bailly, M.[2019]

The dialectical pain management (DPM) intervention, involving 17 adults with chronic pain over 8 weeks, was found to be feasible and well-accepted, with 70% of participants attending six or more sessions.

Preliminary results indicated significant improvements in pain acceptance and reductions in depressive symptoms, with some participants even reducing their opioid dosage, suggesting potential effectiveness in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical Pain Management: Feasibility of a Hybrid Third-Wave Cognitive Behavioral Therapy Approach for Adults Receiving Opioids for Chronic Pain. Barrett, D., Brintz, CE., Zaski, AM., et al.[2021]

A single-session telehealth class called 'Pain, Stress, and Emotions' (PSE) using Emotional Awareness and Expression Therapy (EAET) significantly reduced pain intensity and interference in 74 adults with chronic pain, with a medium effect size of 0.60 at 4 weeks.

Participants reported high satisfaction with the PSE class, and one-quarter experienced clinically meaningful pain reduction, suggesting that this easily delivered intervention could be beneficial for managing chronic pain, although further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Ziadni, MS., Sturgeon, JA., Lumley, MA.[2023]

This pilot study involving 24 adults with chronic low back pain aims to assess the feasibility and acceptability of a 5-day conscious connected breathing intervention compared to a sham control, focusing on participant recruitment, adherence, and satisfaction.

If successful, this study could pave the way for a larger trial to evaluate the efficacy of breathing practices as a self-management strategy for chronic pain, highlighting the potential of non-pharmacological interventions in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study. Pratscher, SD., Sibille, KT., Fillingim, RB.[2023]

The Relaxation Response Resiliency Program (R3P) was found to be highly feasible and well-accepted by patients with chronic temporomandibular disorder (TMD), with a 92% completion rate among the 24 participants in the study.

Participants reported significant reductions in pain intensity, frequency, duration, and tolerability after the R3P intervention, indicating that this comprehensive mind-body program is effective in alleviating both subjective and objective symptoms of chronic TMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relaxation Response Resiliency Enhancement Program in the Management of Chronic Refractory Temporomandibular Joint Disorder: Results from a Pilot Study. Vranceanu, AM., Shaefer, JR., Saadi, AF., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06546956

Integrative Breathwork Intervention for Chronic Pain The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate ...

2. reporter.nih.gov reporter.nih.gov/search/Sz95MmEj-Uu3HV2keOw4Nw/project-details/10848481

Project Details - NIH RePORTER Thus, the proposed project will develop and test a novel multicomponent breathwork intervention in people with chronic low back pain, which will inform future ...

3. withpower.com withpower.com/trial/phase-chronic-pain-4-2024-fdb92

Breathwork for Chronic Pain · Info for Participants Research suggests that mindfulness-based treatments, like Mindfulness-Based Stress Reduction (MBSR), can help reduce pain intensity and distress in chronic pain ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/08980101221094973

Evaluation of Guided Respiration Mindfulness Therapy ... Multilevel analysis showed GRMT resulted in statistically significant reductions in overall psychological distress, anxiety, and stress levels, ...

5. nature.com nature.com/articles/s41598-022-27247-y

Effect of breathwork on stress and mental health: A meta- ... Overall, results showed that breathwork may be effective for improving stress and mental health. However, we urge caution and advocate for nuanced research ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35536701/

Evaluation of Guided Respiration Mindfulness Therapy ... Multilevel analysis showed GRMT resulted in statistically significant reductions in overall psychological distress, anxiety, and stress levels, ...

7. lloydlalande.com lloydlalande.com/images/PDF/2022_GRMT_for_nurses_stress.pdf

Evaluation of Guided Respiration Mindfulness ... Multilevel analysis showed GRMT resulted in statistically significant reductions in overall psychological distress, anxiety, and stress levels, as well as ...