Guided Respiration Mindfulness Therapy for Chronic Lower Back Pain

Overseen By Steven Pratscher, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Florida

Must not be taking: Antipsychotics

Disqualifiers: Leg pain, Rheumatic disease, Respiratory disorder, Heart disease, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new breathwork therapy, called Integrative Breathwork Intervention, to help people with chronic lower back pain. The goal is to determine if guided breathing sessions can reduce pain and improve daily life. Participants will attend weekly 60-minute sessions for eight weeks, each led by a trained facilitator. The trial seeks individuals who have experienced persistent low back pain for at least six months and significant pain most days. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anti-psychotic medications, you may not be eligible to participate.

What prior data suggests that this breathwork intervention is safe for people with chronic low back pain?

Research shows that mindfulness practices, such as breathing exercises, are generally safe for managing chronic low back pain and have a strong safety record. One study found that mindful breathing can reduce pain and improve quality of life for people with chronic pain, indicating it is well-tolerated by most. No reports of serious side effects have emerged from the techniques used in Guided Respiration Mindfulness Therapy. As this trial is in its early stages, it focuses on safety and feasibility, making it important to monitor and report any side effects. However, current evidence is promising for those considering joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic lower back pain, such as medications or physical therapy, Guided Respiration Mindfulness Therapy offers a fresh approach by focusing on integrative breathwork. This therapy involves a unique method of using guided breathing exercises to manage pain, potentially improving both physical and mental well-being. Researchers are excited because this non-invasive approach could offer a natural alternative to pain relief, reducing reliance on medications and their possible side effects. Additionally, the therapy's emphasis on mindfulness might help patients develop better coping strategies for pain management.

What evidence suggests that Guided Respiration Mindfulness Therapy is effective for chronic low back pain?

Research has shown that mindful breathing can help manage chronic low back pain. People who practice it report feeling less pain and enjoying a better quality of life. This therapy is safe and often used in mindfulness programs. Additionally, focused meditation, similar to mindful breathing, has helped people with similar pain issues. These findings suggest that Guided Respiration Mindfulness Therapy, which participants in this trial will receive, might benefit those with chronic low back pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Steven Pratscher, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic lower back pain. Participants should be interested in exploring alternative therapies and available to attend eight weekly sessions of breathwork therapy with a trained facilitator.

Inclusion Criteria

I have had lower back pain almost daily for the past 6 months.

Access to internet with a valid email address

Fluent in English

Exclusion Criteria

Ongoing legal action or disability claim related to low back pain

History of hospitalization or treatment of substance use disorder within the past 12 months

Pregnant or plan to become pregnant during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 60-minute breathwork session once a week for 8 weeks

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Integrative Breathwork Intervention

Trial Overview The study tests Guided Respiration Mindfulness Therapy, an integrative breathwork intervention designed to help with chronic low back pain. It involves 60-minute one-on-one sessions focusing on continuous breathing patterns and mindful relaxation over eight weeks.

How Is the Trial Designed?

Group I: Integrative Breathwork Intervention Experimental Treatment 1 Intervention

The integrative, multicomponent breathwork intervention that will be tested in this study is called Guided Respiration Mindfulness Therapy. Participants will receive a 60 minute breathwork session once a week for 8 weeks.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

A qualitative analysis of 57 adults with chronic low back pain revealed that both unique and shared therapeutic processes across cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy were important for participants' experiences.

Key factors contributing to successful treatment included the development of coping skills, therapeutic rapport, and the ability to stay present, highlighting the significance of both specific techniques and common elements in these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative comparison of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain. Cattanach, BK., Thorn, BE., Ehde, DM., et al.[2021]

This study will be the largest randomized controlled trial comparing cognitive behavioral therapy (CBT) and mindfulness-based therapy (MBT) in adults with chronic low back pain (CLBP) who are treated with long-term opioids, involving 766 participants.

The trial aims to evaluate the effectiveness of CBT and MBT in reducing pain intensity and improving function over 12 months, potentially offering safer alternatives to opioid therapy and enhancing quality of life for patients with CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial. Zgierska, AE., Burzinski, CA., Garland, EL., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) was found to be a feasible and well-tolerated treatment for chronic low back pain (CLBP) in a pilot study involving 69 participants, showing significant improvements in pain interference, physical function, and depression after treatment.

While all treatment groups (MBCT, cognitive therapy, and mindfulness meditation) showed improvements, MBCT demonstrated greater sustained benefits over mindfulness meditation at follow-up, suggesting it may be a more effective long-term option for managing CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain. Day, MA., Ward, LC., Ehde, DM., et al.[2020]

A study involving 16 volunteers with persistent back pain revealed that mindfulness-based techniques significantly changed participants' experiences of pain, leading to greater acceptance and improved quality of life.

Participants reported key changes such as a new relationship with pain, increased self-compassion, and the ability to respond to pain with acceptance rather than fear, indicating the potential of mindfulness in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiencing Wellness Within Illness: Exploring a Mindfulness-Based Approach to Chronic Back Pain. Doran, NJ.[2022]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce pain intensity in adults with chronic low back pain (CLBP), based on a meta-analysis of 18 studies that utilized validated pain outcome measures.

Despite the promising results indicating a large effect size for MBIs, the findings should be interpreted cautiously due to variability in study methodologies, small sample sizes, and potential biases, highlighting the need for more robust large-scale randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis. Paschali, M., Lazaridou, A., Sadora, J., et al.[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]

Inspiratory muscle training (IMT) significantly improved core muscle activity and respiratory function in athletes with chronic low back pain (CLBP) after 8 weeks of training, indicating its efficacy as a rehabilitation method.

Participants in the IMT group also experienced a reduction in pain intensity, as measured by the Visual Analogue Scale, suggesting that IMT not only enhances muscle function but also alleviates pain associated with CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Rehabilitation of Low Back Pain: A Randomized Controlled Trial. Ahmadnezhad, L., Yalfani, A., Gholami Borujeni, B.[2021]

Mindfulness and meditation significantly help older adults (aged 65 and older) cope with chronic low back pain by reducing negative emotions like fear and changing their perspective on pain, as revealed through focus group discussions with 25 participants who completed an eight-week program.

Key themes identified include overcoming fear of pain, increased awareness of pain rather than focusing on it, and a shift in how significant they perceive their pain, suggesting that mindfulness can effectively alter the emotional and cognitive responses to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. Luiggi-Hernandez, JG., Woo, J., Hamm, M., 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-2-low-back-pain-8-2024-ed8fb

Guided Respiration Mindfulness Therapy for Chronic ... Mindfulness-based interventions, which include breathing practices, have an excellent safety profile and are generally considered safe for managing chronic low ...

4. painmanagementnursing.org painmanagementnursing.org/article/S1524-9042(24)00152-8/fulltext

Mindful Breathing as an Adjunctive Approach to Chronic ... Mindful breathing holds promise for chronic low back pain management, with studies revealing pain reduction and improved quality of life.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0965229916300358

Effectiveness of focused meditation for patients with ... Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9872326/

Conscious connected breathing with breath retention ... This will be the first study to examine the effects of a conscious connected breathing with breath retention intervention for individuals with chronic pain.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00494845

Mindfulness Meditation for Chronic Low Back Pain in Older ... These techniques take regular activities like sitting, walking and lying down and transform them into a meditation through directed breathing and mindful ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06546956/integrative-breathwork-intervention-for-chronic-pain

Integrative Breathwork Intervention for Chronic Pain This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing ...