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Mind Body 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039139
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Brief Summary:
The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of mind body interventions (treatment arms) in reducing disability from back pain and alleviating back pain in participants as compared to usual care (control arm ). The investigators will secondarily investigate whether mind body interventions improve participant quality of life and reduce the need for pain-related hospitalization.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Usual Care, Intervention
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be partially blinded. Participants in the usual care 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 Therapy for the Treatment of Chronic Pain
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
No Intervention: Usual Care
Participants will continue their usual care for 26 weeks
Active Comparator: 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.

Experimental: 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.




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


Secondary Outcome Measures :
  1. Average Pain: Brief Pain Inventory Survey [ Time Frame: 4 weeks, 8 weeks, 13, weeks, 26 weeks ]
    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: 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 Survey [ Time Frame: 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. Pain affecting enjoyment of life [ Time Frame: 4 weeks, 8 weeks, 13 weeks, 26 weeks ]
    Scale 0-10 with 10 being worst from Brief Pain Inventory

  5. Anxiety from pain: Pain Anxiety Symptom Scale-20 survey [ Time Frame: 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'

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

  7. Complete resolution of pain disability: Roland Morris Disability [ Time Frame: 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)



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 back pain
  • Pain persistent for ≥3 days/week for the past 3 months prior to enrollment
  • Willingness to consider mind-body intervention

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), cauda equina syndrome. 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.

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): NCT04039139


Contacts
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Contact: Francesca Montillo, MM 617-754-2341 fmontill@bidmc.harvard.edu
Contact: Michael Donnino, MD 617-754-2341 mdonnino@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Michael W 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
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Responsible Party: Michael Donnino, Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04039139    
Other Study ID Numbers: 2018P000578
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators will not be sharing IPD data with researchers outside of their research group.

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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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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms