Mind Body Syndrome Therapy for Chronic Pain

Mind Body Syndrome Therapy for the Treatment of Chronic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Chronic Pain Syndrome
• Intervention / Treatment: Behavioral: Mind Body Intervention 1; Behavioral: Mind body intervention 2

Detailed Description

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 (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shivani Mehta, BA; Phone Number: 617-754-2885; Email: smehta3@bidmc.harvard.edu
• Study Contact Backup: Name: Michael Donnino, MD; Phone Number: 617-754-2885; Email: mdonnino@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Michael Donnino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (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 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

Exclusion Criteria:

• Patients < 18 years of age
• Patients > 67 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 (note that 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; Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.	Behavioral: Mind Body Intervention 1; Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Active Comparator: Mind-Body Intervention 2; Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.	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 (Scale 0-24 with 24 being worst)	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pain	Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)	Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
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	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain bothersomeness: Brief Pain Inventory	Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Anxiety from pain	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'	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Self-reported hospital admissions	Self reported. Number of pain-related hospital admissions, including emergency room visits	Baseline, 26 weeks
Complete resolution of pain disability	complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Pain affecting enjoyment of life	Scale 0-10 with 10 being worst from Brief Pain Inventory	Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Complete resolution of back pain	complete resolution of pain as measured on scale 0-10	Baseline, 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): May 20, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

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: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Syndrome; Chronic Pain
• Other Study ID Numbers: 2020P000147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No