Mind Body Therapy for the Treatment of Chronic Pain
Primary Purpose
Chronic Pain, Chronic Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Mind Body Intervention 2
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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.
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Usual Care
Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Mind Body Intervention 2
Arm Description
Participants will continue their usual care for 26 weeks
Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes.
Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes.
Outcomes
Primary Outcome Measures
Pain Disability: Roland Morris Disability Index
Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Secondary Outcome Measures
Average Pain: Brief Pain Inventory Survey
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 Survey
Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)
Pain affecting enjoyment of life
Scale 0-10 with 10 being worst from Brief Pain Inventory
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'
Pain-related hospital admissions
Self reported. Number of pain-related hospital admissions, including emergency room visits
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)
Full Information
NCT ID
NCT04039139
First Posted
July 29, 2019
Last Updated
January 10, 2023
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04039139
Brief Title
Mind Body Therapy for the Treatment of Chronic Pain
Official Title
Mind Body Therapy for the Treatment of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
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
No
5. Study Description
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.
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
Usual Care, Intervention
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will continue their usual care for 26 weeks
Arm Title
Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Arm Type
Experimental
Arm Description
Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes.
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. Further details are not provided for blinding purposes.
Intervention Type
Behavioral
Intervention Name(s)
Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Other Intervention Name(s)
MBST
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: Roland Morris Disability Index
Description
Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Time Frame
change over 26 weeks
Secondary Outcome Measure Information:
Title
Average Pain: Brief Pain Inventory Survey
Description
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
Time Frame
4 weeks, 8 weeks, 13, weeks, 26 weeks
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
4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Pain Bothersomeness: Brief Pain Inventory Survey
Description
Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)
Time Frame
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
4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Anxiety from pain: Pain Anxiety Symptom Scale-20 survey
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
4 weeks, 8 weeks, 13 weeks, 26 weeks
Title
Pain-related hospital admissions
Description
Self reported. Number of pain-related hospital admissions, including emergency room visits
Time Frame
26 weeks
Title
Complete resolution of pain disability: Roland Morris Disability
Description
complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)
Time Frame
4 weeks, 8 weeks, 13 weeks, 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will not be sharing IPD data with researchers outside of their research group.
Learn more about this trial
Mind Body Therapy for the Treatment of Chronic Pain
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