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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a group-based mindfulness program can help people with chronic low back pain feel better and improve daily function. Participants will either join eight weekly sessions focused on mindfulness techniques or continue with their usual primary care for pain. It suits individuals who have experienced low back pain for at least three months and feel pain on most days. As an unphased trial, this study explores new ways to manage chronic pain through mindfulness.

Will I have to stop taking my current medications?

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.

What prior data suggests that this group-based mindfulness approach is safe for chronic pain management?

Research has shown that mindfulness-based activities are generally safe and well-tolerated for treating long-term low back pain. In various studies, participants who practiced mindfulness reported very few negative effects. Mindfulness-Based Stress Reduction (MBSR), which includes group sessions, has improved pain and movement without major side effects.

One study compared mindfulness with other treatments and found both to be effective and safe for managing long-term pain. This suggests mindfulness can be a dependable option for those considering this method. Overall, mindfulness practices are usually considered low-risk, making them a promising choice for those seeking relief from ongoing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Pain Program because it offers a unique approach to managing chronic lower back pain by incorporating mindfulness-based stress reduction techniques. Unlike standard treatments that typically rely on medications like NSAIDs or opioids and physical therapy, this program focuses on teaching participants to manage pain through mental and emotional strategies. The program involves 8 weekly sessions that aim to reduce stress and improve pain perception, potentially offering a holistic and non-pharmacological alternative to traditional pain management methods. This could be particularly beneficial for patients looking to reduce medication use and its associated side effects.

What evidence suggests that group-based mindfulness is effective for chronic low back pain?

This trial will compare Mindfulness-Based Stress Reduction (MBSR) with usual primary care provider (PCP) care for chronic low back pain. Studies have shown that MBSR can improve movement in people with chronic low back pain. Research indicates that MBSR therapy alleviates back pain and movement limitations more effectively than usual care. Participants in previous studies reported feeling better both 8 weeks and 6 months after starting MBSR. Additionally, MBSR has proven to be more cost-effective than usual care. These findings suggest that MBSR could be a beneficial option for managing chronic low back pain. ^{1 4 6 7 8}

Who Is on the Research Team?

Natalia Morone, MD MS

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388122000913

The effectiveness of mindfulness-based stress reduction ... MBSR therapy improves physical function at 8 weeks and 6 months follow-up in CLBP individuals. Further high-quality RCTs are warranted for the long-term effect.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37942696/

Mindfulness-based Interventions for Chronic Low Back Pain This systematic review aimed to compile existing evidence examining the effects of mindfulness-based interventions (MBIs) for chronic low back pain (CLBP).

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2504811

Effect of Mindfulness-Based Stress Reduction vs Cognitive ... Treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks.

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0276734

A randomized controlled clinical trial | PLOS One The MBSR has been shown to be cost saving when compared with usual care alone for chronic lower back pain [23]. That seminal study has ...

5. researchprotocols.org researchprotocols.org/2022/9/e37823/

Mindfulness-Based Stress Reduction, Cognitive Behavioral ... Background: Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04129450

Group-based Mindfulness for Chronic Pain in the Primary ... 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.

7. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/optimum/

Group-Based Mindfulness for Patients With Chronic Low ... The primary goal of OPTIMUM is to determine the impact of a group-based mindfulness intervention under usual care circumstances.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...