Behavioral Interventions for Chronic Musculoskeletal Pain

(Brief Relief Trial)

Overseen By Adam Hanley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cancer, Unstable illness, Recent surgery, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 session or 8 weeks

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how varying lengths of online training sessions can help individuals better manage chronic musculoskeletal pain. The sessions include two brief ones lasting 2 hours each and a standard-length one spanning 8 weeks with weekly 2-hour sessions. Researchers aim to determine which approach provides the best pain relief. Individuals with ongoing muscle or joint pain, who have rated their pain at least a 3 out of 10 over the past week, may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to explore innovative pain management strategies tailored to participants' needs.

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. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness-oriented recovery enhancement (MORE) is safe for individuals with chronic pain. Studies have found that this treatment can reduce pain and improve quality of life without causing serious side effects.

The shorter version of this treatment, called B-MORE, is also considered safe. It involves shorter sessions but aims for similar results.

Empowered Relief (ER) is another safe option. It consists of a one-time, two-hour session that helps individuals manage pain. Research confirms it does not cause major side effects and effectively improves pain management.

All these treatments are types of behavioral therapy, which are generally safe. They focus on teaching skills to manage pain instead of using medications, resulting in a low risk of harm. Overall, participants can expect these treatments to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic musculoskeletal pain because they focus on novel, non-drug approaches. Unlike traditional pain management options like opioids and NSAIDs, these treatments leverage mindfulness and psychological techniques to provide relief. B-MORE offers a streamlined, 2-hour session based on the MORE program, making it accessible and time-efficient. MORE, on the other hand, is an 8-week comprehensive program that combines mindfulness with cognitive-behavioral techniques. Empowered Relief is another 2-hour intervention that is evidence-based and designed to teach pain management skills quickly. These approaches are unique because they empower patients to manage pain through mental and behavioral strategies, potentially reducing reliance on medication.

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

This trial will compare different behavioral interventions for chronic musculoskeletal pain. Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE), one of the treatments in this trial, can reduce pain by altering brain focus. Studies indicate that MORE effectively lessens attention to pain over eight weeks. Another treatment option, Brief Mindfulness-Oriented Recovery Enhancement (B-MORE), involves just one shorter session and has improved pain-related outcomes for up to three months.

Empowered Relief (ER) is another promising treatment in this trial. Research suggests that a single session of ER can provide significant pain relief, similar to longer cognitive behavioral therapy. ER has reduced negative thoughts about pain, with many participants experiencing meaningful improvements. Overall, research supports these treatments as effective for managing chronic musculoskeletal pain. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with chronic musculoskeletal pain who are interested in exploring different durations of pain management training. Participants must be able to attend online sessions and complete surveys at specified times.

Inclusion Criteria

I am 18 years old or older.

Understanding English instructions fluently

I have long-term muscle or joint pain.

Exclusion Criteria

Unstable illness that may interfere with treatment

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

I have completed a mindfulness training program or Empowered Relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single 2-hour online session or an 8-week program with weekly 2-hour online sessions, focusing on pain management techniques.

1 session or 8 weeks

1 online session or 8 online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment through surveys at multiple time points.

36 weeks

Surveys at 2, 6, 12, 24, and 36 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Brief Mindfulness-Oriented Recovery Enhancement (B-MORE)
• Empowered Relief
• Mindfulness Oriented Recovery Enhancement

Trial Overview The study compares two brief, single-session interventions (B-MORE and Empowered Relief) against a traditional 8-week program (MORE), all aimed at managing chronic pain through mindfulness and other techniques taught by trained facilitators.

How Is the Trial Designed?

Group I: Mindfulness Oriented Recovery Enhancement (MORE) Experimental Treatment 1 Intervention

MORE is an 8-week evidence-based treatment for chronic pain.

Group II: Empowered Relief (ER) Experimental Treatment 1 Intervention

ER is an evidence-based 2-hour single session intervention for chronic pain

Group III: Brief Mindfulness Oriented Recovery Enhancement (B-MORE) Experimental Treatment 1 Intervention

B-MORE is a 2-hour, single session adaptation of the traditional MORE program.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07193095

Study Details | NCT07193095 | This Project is a Three-arm ... MORE is an 8-week evidence-based treatment for chronic pain. Intervention/Treatment, Behavioral : Mindfulness Oriented Recovery Enhancement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9260614/

Protocol for mindfulness-oriented recovery enhancement ... This manuscript outlines the protocol for a randomized clinical trial to evaluate the efficacy of a virtually administered, 8-week MORE ...

3. patlynk.com patlynk.com/trial/NCT07193095

Mindfulness Intervention for Chronic Musculoskeletal Pain ... The study aims to determine how different lengths of pain management training can help reduce pain effectively. By comparing two brief training sessions against ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4076008/

Mindfulness-Oriented Recovery Enhancement for Chronic ... Mindfulness-Oriented Recovery Enhancement reduces pain attentional bias in chronic pain patients. Psychotherapy and Psychosomatics. 2013;82:311–318. doi ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/14/7/e082611.full.pdf

study protocol for a multisite randomised feasibility trial ... 14. Combining exercise- based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain15 and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07207174

Study Details | NCT07207174 | Brief Mindfulness-Oriented ... This randomized controlled trial aims to test both English and Spanish versions of two, benign behavioral interventions for adults with chronic ...

7. researchgate.net researchgate.net/publication/336182101_Mindfulness-oriented_recovery_enhancement_reduces_opioid_misuse_risk_via_analgesic_and_positive_psychological_mechanisms_A_randomized_controlled_trial

Mindfulness-Oriented Recovery Enhancement Reduces ... The aim of this study was to conduct a theory-driven mechanistic analysis of proximal outcome data from a Stage 2 randomized controlled trial of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293391/

PT-IN-MIND: study protocol for a multisite randomised ... Combining exercise-based interventions with mindfulness practices is effective for patients with chronic musculoskeletal pain and engaging in ...