Mind Body Syndrome Therapy for Chronic Pain

NCT04689646 | Recruiting DMC

• 1 other identifier: 2020P000147
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Conditions

Chronic Pain; Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain Disability

  Roland Morris Disability Index (Scale 0-24 with 24 being worst)

  26 weeks

Secondary Outcomes (6)

• Average pain

  Baseline, 4, 8, 13, and 26 weeks after initiation of the study.

• Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey

  Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

• Anxiety from pain

  Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

• Resolution of pain disability

  Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

• Pain affecting enjoyment of life

  Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

Study Arms (3)

Mind-Body Intervention 1

EXPERIMENTAL

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.

Behavioral: Mind Body Intervention 1

Mind-Body Intervention 2

ACTIVE COMPARATOR

Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.

Behavioral: Mind body intervention 2

Usual Care

NO INTERVENTION

Participants will continue their usual care for 26 weeks

Interventions

Mind Body Intervention 1 BEHAVIORAL

Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.

Mind-Body Intervention 1

Mind body intervention 2 BEHAVIORAL

Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Mind-Body Intervention 2

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient 18 ≥ years old
• Chronic back pain
• Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
• Willingness to consider mind-body intervention
• At least score of 2 or more on Roland Disability Questionnaire
• At least score of 3 or more back pain bothersomeness

You may not qualify if:

• Patients \< 18 years of age
• Patients \> 67 years of age
• Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Kukler, BA

CONTACT

617-754-2885; skukler@bidmc.harvard.edu

Michael Donnino, MD

CONTACT

617-754-2885; mdonnino@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Participants in Mind-Body Intervention 2 arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: May 20, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)