Mind Body Syndrome Therapy for Chronic Pain

Study Overview
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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.

Official Title
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Mind Body Syndrome 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
* 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 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: Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Intervention 1<br>Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1. | Behavioral: Mind Body Intervention 1<br>* Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.<br>|
| Active Comparator: Mind-Body Intervention 2<br>Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2. | Behavioral: Mind body intervention 2<br>* Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.<br>|
| No Intervention: Usual Care<br>Participants will continue their usual care for 26 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability | Roland Morris Disability Index (Scale 0-24 with 24 being worst) | 26 weeks | 

Secondary Outcome Measures

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