Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain

September 28, 2024 updated by: Michael Donnino, Beth Israel Deaconess Medical Center
To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBS therapy education
Behavioral: One-on-one interview and educational sessions. Reading material for educational series provided.
A one-on-one interview with the patient and the principal investigator and group educational sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory Questionnaire
Time Frame: 4 weeks
To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.
4 weeks
SF-12 Health Survey Scoring Demonstration
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score
Time Frame: 2 weeks, 4 weeks, 6 months
2 weeks, 4 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimated)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 28, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P000315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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