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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117921
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE April 16, 2014
First Posted Date  ICMJE April 21, 2014
Last Update Posted Date July 15, 2020
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
  • 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.
  • SF-12 Health Survey Scoring Demonstration [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
  • Brief Pain Inventory Questionnaire [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2014)
SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score [ Time Frame: 2 weeks, 4 weeks, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Official Title  ICMJE Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: MBS therapy education
Intervention: Behavioral: One-on-one interview and educational sessions. Reading material for educational series provided.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02117921
Other Study ID Numbers  ICMJE 2013P000315
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Donnino, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP