Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-05-20
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mind-Body Intervention 1
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
Mind Body Intervention 1
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Mind-Body Intervention 2
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
Mind body intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Usual Care
Participants will continue their usual care for 26 weeks
No interventions assigned to this group
Interventions
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Mind Body Intervention 1
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Mind body intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Eligibility Criteria
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Inclusion Criteria
* Chronic back pain
* Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment
* Willingness to consider mind-body intervention
* At least score of 2 or more on Roland Disability Questionnaire
* At least score of 3 or more back pain bothersomeness
Exclusion Criteria
* Patients \> 67 years of age
* Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome (note that pain related to disc disease is not an exclusion unless there are neurological impairments)
* Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia, and bipolar disorder
18 Years
67 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Michael Donnino
Associate Professor of Emergency Medicine
Principal Investigators
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Michael Donnino, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Michael Donnino, MD
Role: primary
Other Identifiers
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2020P000147
Identifier Type: -
Identifier Source: org_study_id
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