Mind Body Syndrome Therapy for Chronic Pain

NCT ID: NCT04689646

Last Updated: 2024-08-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Chronic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

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.

Group Type EXPERIMENTAL

Mind Body Intervention 1

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Mind body intervention 2

Intervention Type BEHAVIORAL

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

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Mind body intervention 2

Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Michael Donnino

Associate Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Samuel Kukler, BA

Role: CONTACT

617-754-2885

Michael Donnino, MD

Role: CONTACT

617-754-2885

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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