Clinical trial NCT04689646: Mind Body Syndrome Therapy for Chronic Pain
Official title: Mind Body Syndrome Therapy for the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Chronic Pain Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Disability
timeFrame: 26 weeks
Secondary outcomes:
measure: Average pain
timeFrame: Baseline, 4, 8, 13, and 26 weeks after initiation of the study.
measure: Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Pain bothersomeness: Brief Pain Inventory
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Anxiety from pain
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Self-reported hospital admissions
timeFrame: Baseline, 26 weeks
measure: Complete resolution of pain disability
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Pain affecting enjoyment of life
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Complete resolution of back pain
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References: