Back to resultsMind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One-on-one interview and educational sessions. Reading material for educational series provided.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Mind Body Syndrome, MBS, Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Adult patient 18 > years old
- Chronic pain without clear organic etiology after full evaluation by primary care physician or subspecialist
- Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
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)
- Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia and bi-polar disorder. Mild to moderate depression and anxiety will not be considered as exclusions
- Pregnancy
- Severe depression or recent suicide attempt
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MBS therapy education
Arm Description
Outcomes
Primary Outcome Measures
Brief Pain Inventory Questionnaire
To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.
SF-12 Health Survey Scoring Demonstration
Secondary Outcome Measures
SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score
Full Information
NCT ID
NCT02117921
First Posted
April 16, 2014
Last Updated
July 13, 2020
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02117921
Brief Title
Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Official Title
Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Mind Body Syndrome, MBS, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBS therapy education
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
One-on-one interview and educational sessions. Reading material for educational series provided.
Intervention Description
A one-on-one interview with the patient and the principal investigator and group educational sessions.
Primary Outcome Measure Information:
Title
Brief Pain Inventory Questionnaire
Description
To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.
Time Frame
4 weeks
Title
SF-12 Health Survey Scoring Demonstration
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score
Time Frame
2 weeks, 4 weeks, 6 months
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 pain without clear organic etiology after full evaluation by primary care physician or subspecialist
Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
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)
Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia and bi-polar disorder. Mild to moderate depression and anxiety will not be considered as exclusions
Pregnancy
Severe depression or recent suicide attempt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W 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
Learn more about this trial
Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
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