Mind Body Therapy for the Treatment of Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Chronic Pain Syndrome
• Intervention / Treatment: Behavioral: Mind Body Intervention 2; Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients < 18 years of age
• Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome. Pain related to disc disease is not an exclusion unless there are neurological impairments.
• Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia and bipolar disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants will continue their usual care for 26 weeks
Experimental: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST); 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 techniques for Intervention 1 will be taught in lectures and group discussion sessions.; Other Names: MBST
Active Comparator: Mind Body Intervention 2; 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; Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain: Brief Pain Inventory Survey	Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)	4 weeks, 8 weeks, 13, weeks, 26 weeks
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey	Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain Bothersomeness: Brief Pain Inventory Survey	Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain affecting enjoyment of life	Scale 0-10 with 10 being worst from Brief Pain Inventory	4 weeks, 8 weeks, 13 weeks, 26 weeks
Anxiety from pain: Pain Anxiety Symptom Scale-20 survey	Anxiety from pain as determined from the Pain Anxiety Symptom Scale-20 survey (20 questions with scale of 0-5 with 5 being 'always' and 0 being 'never'	4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain-related hospital admissions	Self reported. Number of pain-related hospital admissions, including emergency room visits	26 weeks
Complete resolution of pain disability: Roland Morris Disability	complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)	4 weeks, 8 weeks, 13 weeks, 26 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2018P000578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators will not be sharing IPD data with researchers outside of their research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No