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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02117921
Other study ID # 2013P000315
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date December 2020

Study information

Verified date July 2020
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary SF-12 Health Survey Scoring Demonstration 4 weeks
Secondary SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score 2 weeks, 4 weeks, 6 months
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