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

Trial Summary

What is the purpose of this trial?

The proposed research is to develop and refine a multicomponent breathwork intervention, Guided Respiration Mindfulness Therapy, and to iteratively evaluate its feasibility, acceptability, and plausibility for clinically significant effects in people with chronic low back pain. This integrative breathwork intervention involves a 60-minute breathing session where the focus is to maintain a conscious connected breathing pattern (no pause between inhale and exhale), apply mindful acceptance to somatic sensations, and relax any physical tension. Each breathwork session will be delivered 1-on-1 in person by a trained facilitator. The treatment consists of 8 breathwork sessions, once per week for 8 weeks.

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 data supports the effectiveness of the treatment Guided Respiration Mindfulness Therapy for Chronic Lower Back Pain?

Research shows that mindfulness-based techniques, including breathwork, can help people with chronic back pain by changing their experience of pain, increasing acceptance, and improving quality of life. Breathing practices are linked to stress and pain management, suggesting they could be effective self-management strategies for chronic pain. ^{1 2 3 4 5}

Is Guided Respiration Mindfulness Therapy safe for humans?

Mindfulness-based interventions, which include breathing practices, have an excellent safety profile and are generally considered safe for managing chronic low back pain. ^{1 2 3 6 7}

How is Guided Respiration Mindfulness Therapy different from other treatments for chronic lower back pain?

Guided Respiration Mindfulness Therapy is unique because it focuses on conscious connected breathing and breath retention, which can be practiced at home to help manage stress, emotions, and pain. This approach leverages the connection between breathing and the body's stress response, offering a self-management strategy that differs from traditional physical therapies or medications. ^{1 2 3 4 8}

Research Team

Steven Pratscher, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

Pregnant or plan to become pregnant during the study period

I have back pain that may be caused by a serious condition like cancer.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Mindfulness for Chronic Low Back Pain: A Qualitative Analysis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training in Rehabilitation of Low Back Pain: A Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A qualitative comparison of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain. [2021]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis. [2023]

8. England 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. [2020]