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Behavioural Intervention

Mindfulness-Based Stress Reduction for Chronic Pain (OPTIMUM Trial)

N/A

Waitlist Available

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

Must not have

Metastatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks, 6 months,12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have had lower back pain for at least 3 months, with pain on most days in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks, 6 months,12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks, 6 months,12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks, 6 months,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain intensity and interference at Baseline, 8 weeks, 6 months (primary timepoint), & 12 months: PEG score

Secondary study objectives

Amount of opioid pain medication

Anxiety at Baseline

Chronic overlapping pain at 8 weeks

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met