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Mind Body Syndrome Therapy for Chronic Pain

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ClinicalTrials.gov Identifier: NCT04689646
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care and an active control (second mind body intervention). The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.

Condition or disease Intervention/treatment Phase
Chronic Pain Chronic Pain Syndrome Behavioral: Mind Body Intervention 1 Behavioral: Mind body intervention 2 Not Applicable

Detailed Description:
The goal of this study is to determine if a mind-body intervention can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of a mind body intervention in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm) and an active control arm. The investigators will secondarily investigate whether the intervention alleviates anxiety related to the pain and other quality of life parameters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double (Participant, Outcomes Assessor) Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Participants in Mind-Body Intervention 2 arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
Primary Purpose: Treatment
Official Title: Mind Body Syndrome Therapy for the Treatment of Chronic Pain
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mind-Body Intervention 1
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1.
 Behavioral: Mind Body Intervention 1
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
Active Comparator: Mind-Body Intervention 2
Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2.
 Behavioral: Mind body intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
No Intervention: Usual Care
Participants will continue their usual care for 26 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Pain Disability [ Time Frame: 26 weeks ]
    Roland Morris Disability Index (Scale 0-24 with 24 being worst)


Secondary Outcome Measures :
  1. Average pain [ Time Frame: Baseline, 4, 8, 13, and 26 weeks after initiation of the study. ]
    Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)

  2. Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst

  3. Pain bothersomeness: Brief Pain Inventory [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)

  4. Anxiety from pain [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    Anxiety from pain as determined from the Pain Anxiety Symptom Scale-20 survey (20 questions with scale of 0-5 with 5 being 'always' and 0 being 'never'

  5. Self-reported hospital admissions [ Time Frame: Baseline, 26 weeks ]
    Self reported. Number of pain-related hospital admissions, including emergency room visits

  6. Complete resolution of pain disability [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)

  7. Pain affecting enjoyment of life [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    Scale 0-10 with 10 being worst from Brief Pain Inventory

  8. Complete resolution of back pain [ Time Frame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    complete resolution of pain as measured on scale 0-10


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patient 18 ≥ years old
  • 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 < 18 years of age
  • 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
Contacts and Locations
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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): NCT04689646


Contacts
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Contact: Shivani Mehta, BA 617-754-2885 smehta3@bidmc.harvard.edu
Contact: Michael Donnino, MD 617-754-2885 mdonnino@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Donnino, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Michael Donnino, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Michael Donnino, Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04689646    
Other Study ID Numbers: 2020P000147
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Chronic Pain
Disease
 Pathologic Processes
Pain
Neurologic Manifestations