Behavioral Intervention for Pain

Overseen By Allison R Davis, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Physical or mental incapacity

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

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

80 Participants Needed

Trial Summary

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

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

What data supports the effectiveness of the treatment Mindfulness Pain Management for chronic pain?

Research shows that mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), can help reduce pain intensity and improve physical functioning in people with chronic pain. These treatments focus on being present and nonjudgmental, which can increase pain tolerance and reduce distress related to pain. ^{1 2 3 4 5}

Is mindfulness-based pain management safe for humans?

Mindfulness-based interventions, like mindfulness-based stress reduction (MBSR), are generally considered safe for managing pain in humans, as they are non-drug approaches and have been reviewed for their feasibility and acceptability in various studies. ^{1 5 6 7 8}

How is the Mindfulness Pain Management treatment different from other treatments for chronic pain?

Mindfulness Pain Management is unique because it focuses on nonjudgmental awareness of the present moment, which can change how patients experience pain without directly aiming to control it. Unlike traditional treatments like cognitive behavioral therapy (CBT), it emphasizes acceptance and awareness, potentially improving pain tolerance and reducing pain intensity. ^{1 3 5 8 9}

What is the purpose of this trial?

This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.

Eligibility Criteria

This trial is for adults over 18 who are currently receiving pain treatment at the Tallahassee Orthopedic Clinic. Participants must understand English, be able to avoid starting new treatments during the study, and have the capacity to consent.

Inclusion Criteria

Receiving pain treatment at Tallahassee Orthopedic Center

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

Understanding English instructions fluently

Exclusion Criteria

I am unable to give consent due to physical or mental reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a 7-minute mindfulness intervention for pain management before an orthopedic procedure

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for treatment satisfaction and changes in pain and anxiety immediately after the intervention

1 hour

Treatment Details

Interventions

• Mindfulness Pain Management
• Pain Psychoeducation

Trial Overview The trial is testing a brief behavioral intervention for pain that includes Pain Psychoeducation and Mindfulness Pain Management. It's a randomized controlled trial where patients are assigned by chance to one of two groups.

Participant Groups

Group I: Mindfulness Pain Management Experimental Treatment 1 Intervention

Group II: Pain Psychoeducation Active Control 1 Intervention

Mindfulness Pain Management is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Pain Management for:

• Chronic Pain
• Acute Pain
• Orthopedic Pain

Approved in European Union as Mindfulness-Based Pain Management for:

• Chronic Pain
• Cancer Pain
• Musculoskeletal Pain

Approved in Canada as Mindfulness-Based Pain Management for:

• Chronic Pain
• Acute Pain
• Palliative Care

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Findings from Research

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]

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]

Mindfulness-based interventions (MBIs) significantly reduce pain intensity in chronic pain patients, with 10 out of 16 studies showing decreased pain ratings, especially in clinical pain samples.

Most controlled trials indicated that MBIs led to greater reductions in pain intensity compared to control groups, and these benefits were generally maintained in follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. Reiner, K., Tibi, L., Lipsitz, JD.[2022]

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]

A systematic review of 20 studies on brief mindfulness-based interventions (BMBIs) suggests that they may be effective for managing acute pain, especially when delivered by a provider and lasting more than 5 minutes.

However, the overall evidence is limited and inconclusive, indicating that more rigorous and larger-scale studies are necessary before BMBIs can be recommended as a primary treatment for chronic or acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. McClintock, AS., McCarrick, SM., Garland, EL., et al.[2023]

A feasibility study involving 96 participants showed that an 8-week online program combining mindfulness-based stress reduction (MBSR) and exercise (MOVE group) was well-accepted, with 83.3% completing the intervention and higher satisfaction scores compared to a self-management group.

Both the MOVE and self-management groups reported improvements in pain and related measures, indicating that both interventions are feasible and effective, supporting the need for a larger randomized controlled trial to further evaluate the combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Combined With Exercise Online (MOVE) Compared With a Self-management Guide for Adults With Chronic Pain: A Feasibility Randomized Controlled Trial. Deegan, O., Fullen, BM., Casey, MB., et al.[2023]

Mindfulness-based stress reduction (MBSR) techniques significantly improve subjective pain scores and quality of life in chronic pain patients, particularly those with chronic low back pain, based on a review of 12 empirical studies.

Despite some limitations such as small sample sizes and varied pain measurement tools, the evidence suggests that MBSR can be an effective non-pharmacological treatment option for managing chronic pain and enhancing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. Smith, SL., Langen, WH.[2022]

The study will evaluate two innovative mindfulness-based interventions (MBIs) for chronic pain management in Veterans, aiming to overcome implementation barriers associated with traditional mindfulness-based stress reduction.

The trial will compare the effectiveness of a group-based MBI (Mobile+Group LAMP) and an individual MBI (Mobile LAMP) against usual care, measuring outcomes like pain interference and mental health over 12 months, which could lead to improved treatment options for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Burgess, DJ., Evans, R., Allen, KD., et al.[2022]

This systematic review and meta-analysis aims to compare the effectiveness of mindfulness-based stress reduction (MBSR) and cognitive behavioral therapy (CBT) in treating chronic pain disorders, which affect 10%-30% of Canadians.

The study will evaluate outcomes such as pain-related disability, pain intensity, emotional distress, and overall functioning, using rigorous methods to ensure reliable comparisons between the two treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons. Hatchard, T., Lepage, C., Hutton, B., et al.[2022]

References

1. England 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. [2023]

2. England 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. [2019]

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

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

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

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. [2023]

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

Mindfulness Combined With Exercise Online (MOVE) Compared With a Self-management Guide for Adults With Chronic Pain: A Feasibility Randomized Controlled Trial. [2023]

7. India pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons. [2022]