search
Back to results

Mind Body Syndrome Therapy for Chronic Pain

Primary Purpose

Chronic Pain, Chronic Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind Body Intervention 1
Mind body intervention 2
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mind-Body Intervention 1

Mind-Body Intervention 2

Usual Care

Arm Description

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

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

Participants will continue their usual care for 26 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Average pain
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
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
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)
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'
Self-reported hospital admissions
Self reported. Number of pain-related hospital admissions, including emergency room visits
Complete resolution of pain disability
complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)
Pain affecting enjoyment of life
Scale 0-10 with 10 being worst from Brief Pain Inventory
Complete resolution of back pain
complete resolution of pain as measured on scale 0-10

Full Information

First Posted
December 27, 2020
Last Updated
January 10, 2023
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04689646
Brief Title
Mind Body Syndrome Therapy for Chronic Pain
Official Title
Mind Body Syndrome Therapy for the Treatment of Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Chronic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Intervention 1
Arm Type
Experimental
Arm Description
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
Arm Title
Mind-Body Intervention 2
Arm Type
Active Comparator
Arm Description
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will continue their usual care for 26 weeks
Intervention Type
Behavioral
Intervention Name(s)
Mind Body Intervention 1
Intervention Description
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Intervention Type
Behavioral
Intervention Name(s)
Mind body intervention 2
Intervention Description
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Primary Outcome Measure Information:
Title
Pain Disability
Description
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Average pain
Description
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
Time Frame
Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
Title
Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey
Description
Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Pain bothersomeness: Brief Pain Inventory
Description
Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Anxiety from pain
Description
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'
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Self-reported hospital admissions
Description
Self reported. Number of pain-related hospital admissions, including emergency room visits
Time Frame
Baseline, 26 weeks
Title
Complete resolution of pain disability
Description
complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Pain affecting enjoyment of life
Description
Scale 0-10 with 10 being worst from Brief Pain Inventory
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Complete resolution of back pain
Description
complete resolution of pain as measured on scale 0-10
Time Frame
Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivani Mehta, BA
Phone
617-754-2885
Email
smehta3@bidmc.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Donnino, MD
Phone
617-754-2885
Email
mdonnino@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Donnino, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Donnino, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mind Body Syndrome Therapy for Chronic Pain

We'll reach out to this number within 24 hrs