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Behavioral Intervention

Mindfulness-Oriented Recovery Enhancement: (MORE) group for Lower Back Pain

N/A
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age greater than 18 years old
Chronic Low Back Pain as seen on medical history as well as a score of greater than 3 on pain visual analog scale (VAS) at the start of experimental sessions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,8 weeks, 3 month and 6 month follow up
Awards & highlights

Study Summary

This trial will look at how mindfulness techniques can help reduce pain and decrease the amount of opioid medication needed in patients with chronic low back pain. 200 patients who are currently using opioids for their chronic pain

Who is the study for?
This trial is for men and women who regularly use opioids to manage chronic low back pain. Participants should be willing to try mindfulness techniques or psychoeducation as a way to reduce their opioid dosage and pain interference.Check my eligibility
What is being tested?
The study tests if Mindfulness-Oriented Recovery Enhancement (MORE) can help lower opioid doses and lessen the impact of pain compared to standard psychoeducation in patients with chronic low back pain.See study design
What are the potential side effects?
Since this trial involves non-drug interventions like mindfulness training, side effects may include temporary discomfort or emotional distress during practice but are generally considered minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I have chronic low back pain with a pain score over 3.
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I can speak and understand English fluently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,8 weeks, 3 month and 6 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,8 weeks, 3 month and 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Dose
Pain Interference
Secondary outcome measures
Opioid Craving
Opioid Misuse
Opioid Withdrawal
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mindfulness-Oriented Recovery Enhancement: (MORE) groupExperimental Treatment1 Intervention
Group II: PsychoeducationPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,750 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being selected for enrollment in this clinical trial?

"Affirmative. The data on clinicaltrials.gov affirms that this research is actively seeking suitable candidates. Initially shared on February 1st, 2024, and most recently modified on February 12th, 2024. This study aims to recruit approximately 200 participants from a single site."

Answered by AI

Are patients currently eligible to participate in this ongoing clinical trial?

"Indeed, the information on clinicaltrials.gov indicates that this research is currently enrolling participants. The trial was first made available on February 1st, 2024 and last revised on February 12th, 2024. Enrollment of about 200 individuals will take place at a single location."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The main focus of this research, assessed at baseline and follow-up time points including 8 weeks, 3 months, and 6 months, is the quantification of Opioid Dose. Additional parameters such as Pain Intensity measured using the Brief Pain Inventory, Opioid Misuse evaluated with the Current Opioid Misuse Measure (COMM), and Opioid Withdrawal gauged by the Opioid Withdrawal Scale (SOWS) will also be examined."

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

im hoping to help clinical trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)
Asimina Lazaridou, PhD 2024. "Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268522.
All > Low Back Pain > Lower Back Pain
~50 spots leftby Jun 2024
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