Mindfulness-Based Stress Reduction for Chronic Pain

(OPTIMUM Trial)

Overseen By Natalia Morone, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Pregnancy, Metastatic cancer, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

451 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.

Research Team

Natalia Morone, MD MS

Principal Investigator

Boston Medical Center

Eligibility Criteria

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.

Inclusion Criteria

You have a score of 3 or higher on the PEG scale.

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

Willing and able to provide online or telephone informed consent

Exclusion Criteria

My cancer has spread to other parts of my body.

Pregnancy

Do not meet the above inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

Pilot to plan and test the group-based mindfulness program for chronic pain at each site

12 months

Treatment

Participants receive 8 weekly 90-minute sessions of Mindfulness-Based Stress Reduction in addition to usual PCP care

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys at multiple timepoints

12 months

Surveys at baseline, 8 weeks, 6 months, and 12 months

Treatment Details

Interventions

• Group-based Mindfulness

Trial Overview 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.

Participant Groups

Group I: Mindfulness Pain Program + Usual PCP Care Experimental Treatment 2 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 Care Active Control 1 Intervention

Participants will receive usual PCP care for chronic lower back pain.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+