Mind Body Therapy for the Treatment of Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Pain Disability: Roland Morris Disability Index
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Michael Donnino
Associate Professor of Emergency Medicine
Beth Israel Deaconess Medical Center
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.
Outcomes
Primary Outcomes
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 Outcomes
- Pain-related hospital admissions(26 weeks)
- Pain Bothersomeness: Brief Pain Inventory Survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Pain affecting enjoyment of life(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Average Pain: Brief Pain Inventory Survey(4 weeks, 8 weeks, 13, weeks, 26 weeks)
- Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Anxiety from pain: Pain Anxiety Symptom Scale-20 survey(4 weeks, 8 weeks, 13 weeks, 26 weeks)
- Complete resolution of pain disability: Roland Morris Disability(4 weeks, 8 weeks, 13 weeks, 26 weeks)