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Behavioural Intervention
Mindfulness-Based Stress Reduction for Chronic Pain (OPTIMUM Trial)
N/A
Recruiting
Led By Natalia Morone, MD, MS
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Chronic low back pain, which is pain that persists for at least 3 months and has resulted in pain on at least half the days in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
OPTIMUM Trial Summary
This trial will study whether a mindfulness-based stress reduction program can improve function for people with chronic low back pain.
Who is the study for?
This trial is for adults over 18 with chronic low back pain lasting at least 3 months, experiencing pain on most days in the past half year. Participants must score ≥3 on the PEG scale, speak English, and be able to consent online or by phone. Excluded are those with recent severe symptoms, pregnancy, metastatic cancer, relatives of OPTIMUM study participants or non-patients of participating clinics.Check my eligibility
What is being tested?
The trial tests if group medical visits using mindfulness-based stress reduction can improve function in people with chronic low back pain compared to usual care from their primary care provider (PCP). It's part of the 'OPTIMUM' program designed for such conditions.See study design
What are the potential side effects?
Mindfulness-based interventions typically have minimal side effects; however, some individuals may experience emotional discomfort when confronting painful thoughts and feelings during practice.
OPTIMUM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had lower back pain for at least 3 months, with pain on most days in the last 6 months.
OPTIMUM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain intensity and interference at 8 weeks: PEG score
Pain intensity and interference at 12 months: PEG score
Pain intensity and interference at 6 months: PEG score
Secondary outcome measures
Opioids
Opioid prescription use at 6 months
Opioid prescription use at 8 weeks
+4 moreOPTIMUM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Pain Program + Usual PCP CareExperimental Treatment2 Interventions
Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain.
Group II: Usual PCP CareActive Control1 Intervention
Participants will receive usual PCP care for chronic lower back pain.
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Who is running the clinical trial?
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
870,699 Total Patients Enrolled
7 Trials studying Back Pain
3,323 Patients Enrolled for Back Pain
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,483 Total Patients Enrolled
50 Trials studying Back Pain
262,985 Patients Enrolled for Back Pain
Natalia Morone, MD, MSPrincipal InvestigatorBoston Medical Center
2 Previous Clinical Trials
116 Total Patients Enrolled
1 Trials studying Back Pain
40 Patients Enrolled for Back Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I am 18 years old or older.In the past month, I've had worsening pain, unexplained fever, or unexplained weight loss.You have a score of 3 or higher on the PEG scale.If any of your close family members (like parents, siblings, or children) have taken part in the OPTIMUM study, you cannot participate.Criterion: People living in the same house.I have had lower back pain for at least 3 months, with pain on most days in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Pain Program + Usual PCP Care
- Group 2: Usual PCP Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the population size of those enrolled in this clinical trial?
"Affirmative. According to the documentation on clinicaltrials.gov, this medical trial which was originally advertised on May 6th 2021 is currently recruiting patients. Approximately 450 individuals need to be enrolled from 1 distinct healthcare facility."
Answered by AI
What aims are being pursued through this experiment?
"The primary endpoint which shall be evaluated over a period of 8 weeks and at baseline is the Pain Interference Group (PEG) score. Secondary outcomes are: Opioid prescription use will be measured through The Current Opioid Misuse Measure® (COMM), Physical function after 12 months assessed with 4-item PROMIS, as well as physical functionality following 8 weeks monitored by 4 item PROMIS."
Answered by AI
Are there vacancies available for participants in this clinical trial?
"According to the clinicaltrials.gov, this research is currently open for enrollment; it's inaugural post was on May 6th 2021 and most recently updated July 26th 2022."
Answered by AI
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