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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a quick 7-minute mindfulness session can help manage pain for individuals undergoing kyphoplasty or radiofrequency ablation, both treatments for back pain. Participants will be divided into two groups: one will engage in mindfulness pain management (a behavioral intervention), while the other will receive pain education. The trial seeks individuals who are undergoing these procedures at the Tallahassee Orthopedic Center and speak English fluently. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

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 prior data suggests that these interventions are safe for pain management?

Research has shown that mindfulness-based methods, such as the Mindfulness Pain Management being studied, are generally safe. Many studies indicate that these practices, which include meditation and stress reduction, can reduce the feeling of pain without causing major side effects. Patients who use them for long-term pain relief generally accept them well.

Pain psychoeducation, another method under exploration, aims to teach patients about pain to help them manage it better. Studies show that its effects can vary and may not always significantly reduce pain, but it is generally safe with little risk of negative effects.

Both treatments in this trial have a good safety record, making them promising options for those interested in exploring non-drug ways to manage pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer non-pharmacological approaches to managing pain. Unlike standard pain treatments that often rely on medication, Mindfulness Pain Management and Pain Psychoeducation focus on changing how patients perceive and react to pain. Mindfulness Pain Management helps patients develop awareness and acceptance of their pain through meditation and mindfulness practices, potentially reducing pain intensity and improving overall well-being. Pain Psychoeducation provides patients with information about pain mechanisms and coping strategies, empowering them to manage their pain more effectively. These approaches are unique in that they aim to equip patients with skills to manage pain long-term without the side effects associated with medication.

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

Research has shown that mindfulness-based treatments, such as those offered in this trial, can reduce the intensity and bother of pain. Studies have found that programs like Mindfulness-Based Stress Reduction (MBSR) lead to significant improvements in pain and its impact on daily activities. Mindfulness techniques, including meditation and stress reduction, have been moderately effective in lowering pain perception. In this trial, another group of participants will receive pain psychoeducation, which teaches people about pain and how to manage it, helping them better understand and cope with their condition. Although direct data on pain psychoeducation is limited, it is generally considered a useful tool for managing pain. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4941786/

Mindfulness meditation–based pain relief: a mechanistic ... The MBSR and CBT programs were found to be significantly more effective at reducing pain intensity and reports of pain being bothersome when compared to usual ...

2. link.springer.com link.springer.com/article/10.1007/s12671-022-02023-1

Mindfulness-Based Pain Management (MBPM) for Chronic ... Mindfulness-based pain management (MBPM) has evidenced significant positive changes in patients with chronic pain, but so far, no RCT study has been conducted.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5069124/

Mindfulness-based stress reduction and cognitive-behavioral ... Mindfulness-based stress reduction (MBSR) is believed to benefit chronic pain patients by increasing mindfulness and pain acceptance.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2504811

Effect of Mindfulness-Based Stress Reduction vs Cognitive ... Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876201817304276

Mindfulness-based interventions for chronic pain There is moderate evidence that mindfulness-based interventions (MBIs) such as meditation, yoga, and stress reduction lower the perception of pain.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514835/

Mindfulness-Based Stress Reduction (MBSR) for Chronic ... Primary outcome measures included: (1) knowledge and awareness of MBSR (12-items); (2) confidence in seeking out MBSR for pain (5-items); (3) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9555327/

Mindfulness-Based Stress Reduction, Cognitive Behavioral ... We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05843409

Study Details | NCT05843409 | Mindfulness-based Stress ... Exclusion Criteria: Patients with Chronic Pain not in Pharmacological Therapy; Patients without Chronic Pain. Ages Eligible for Study.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... This randomized clinical trial compares the long-term impact of mindfulness-based therapy (MBT) vs cognitive behavioral therapy (CBT) in ...