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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

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: One-on-one interview and educational sessions. Reading material for educational series provided. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Study Start Date : February 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. 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.

  2. SF-12 Health Survey Scoring Demonstration [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score [ Time Frame: 2 weeks, 4 weeks, 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117921


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
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Responsible Party: Michael Donnino, Michael W. Donnino, MA, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02117921    
Other Study ID Numbers: 2013P000315
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
Mind Body Syndrome
MBS
Chronic Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations