Clinical trial NCT04039139: Mind Body Therapy for the Treatment of Chronic Pain
Official title: Mind Body Therapy for the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Chronic Pain Syndrome
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Usual Care, Intervention
Primary purpose: TREATMENT

Brief summary: Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. 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 Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.


Eligibility 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.

Primary outcomes:
measure: Pain Disability: Roland Morris Disability Index
timeFrame: change over 26 weeks
Secondary outcomes:
measure: Average Pain: Brief Pain Inventory Survey
timeFrame: 4 weeks, 8 weeks, 13, weeks, 26 weeks
measure: Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey
timeFrame: 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Pain Bothersomeness: Brief Pain Inventory Survey
timeFrame: 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Pain affecting enjoyment of life
timeFrame: 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Anxiety from pain: Pain Anxiety Symptom Scale-20 survey
timeFrame: 4 weeks, 8 weeks, 13 weeks, 26 weeks
measure: Pain-related hospital admissions
timeFrame: 26 weeks
measure: Complete resolution of pain disability: Roland Morris Disability
timeFrame: 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: