Mind Body Therapy for the Treatment of Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Mind Body Therapy for the Treatment of Chronic Pain

Conditions
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Chronic Pain, Chronic Pain Syndrome

Intervention / Treatment
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* Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
* Behavioral: Mind Body Intervention 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Usual Care, Intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants will continue their usual care for 26 weeks | |
| Experimental: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)<br>Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes. | Behavioral: Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)<br>* Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.<br>* Other names: MBST;|
| Active Comparator: Mind Body Intervention 2<br>Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes. | Behavioral: Mind Body Intervention 2<br>* Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability: Roland Morris Disability Index | Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst) | change over 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain: Brief Pain Inventory Survey | Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst) | 4 weeks, 8 weeks, 13, weeks, 26 weeks | 
| Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey | Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst) | 4 weeks, 8 weeks, 13 weeks, 26 weeks | 
| Pain Bothersomeness: Brief Pain Inventory Survey | Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst) | 4 weeks, 8 weeks, 13 weeks, 26 weeks | 
| Pain affecting enjoyment of life | Scale 0-10 with 10 being worst from Brief Pain Inventory | 4 weeks, 8 weeks, 13 weeks, 26 weeks | 
| Anxiety from pain: Pain Anxiety Symptom Scale-20 survey | 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' | 4 weeks, 8 weeks, 13 weeks, 26 weeks | 
| Pain-related hospital admissions | Self reported. Number of pain-related hospital admissions, including emergency room visits | 26 weeks | 
| Complete resolution of pain disability: Roland Morris Disability | complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst) | 4 weeks, 8 weeks, 13 weeks, 26 weeks |