Mind Body Therapy for the Treatment of Chronic Pain

NCT04039139 | Completed

• 1 other identifier: 2018P000578
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.

Conditions

Chronic Pain; Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain Disability: Roland Morris Disability Index

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

  change over 26 weeks

Secondary Outcomes (7)

• Average Pain: Brief Pain Inventory Survey

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

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

  4 weeks, 8 weeks, 13 weeks, 26 weeks

• Pain Bothersomeness: Brief Pain Inventory Survey

  4 weeks, 8 weeks, 13 weeks, 26 weeks

• Pain affecting enjoyment of life

  4 weeks, 8 weeks, 13 weeks, 26 weeks

• Anxiety from pain: Pain Anxiety Symptom Scale-20 survey

  4 weeks, 8 weeks, 13 weeks, 26 weeks

Study Arms (3)

Usual Care

NO INTERVENTION

Participants will continue their usual care for 26 weeks

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

EXPERIMENTAL

Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes.

Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

Mind Body Intervention 2

ACTIVE COMPARATOR

Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes.

Behavioral: Mind Body Intervention 2

Interventions

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST) BEHAVIORAL

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

Also known as: MBST

Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

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+
• 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 ≥3 days/week for the past 3 months prior to enrollment
• Willingness to consider mind-body intervention

You may not qualify if:

• Patients \< 18 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

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be partially blinded. Participants in the usual care 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: Usual Care, Intervention

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: July 30, 2019
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)