Mind Body Syndrome Therapy for Chronic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mind-Body Intervention 1 Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1. |
Behavioral: Mind Body Intervention 1
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
|
| Active Comparator: Mind-Body Intervention 2 Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2. |
Behavioral: Mind body intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
|
| No Intervention: Usual Care Participants will continue their usual care for 26 weeks |
Outcome Measures
Primary Outcome Measures
- Pain Disability [26 weeks]
Roland Morris Disability Index (Scale 0-24 with 24 being worst)
Secondary Outcome Measures
- Average pain [Baseline, 4, 8, 13, and 26 weeks after initiation of the study.]
Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst)
- Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst
- Pain bothersomeness: Brief Pain Inventory [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst)
- Anxiety from pain [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
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'
- Self-reported hospital admissions [Baseline, 26 weeks]
Self reported. Number of pain-related hospital admissions, including emergency room visits
- Complete resolution of pain disability [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst)
- Pain affecting enjoyment of life [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
Scale 0-10 with 10 being worst from Brief Pain Inventory
- Complete resolution of back pain [Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks]
complete resolution of pain as measured on scale 0-10
Eligibility Criteria
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
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
Investigators
- Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020P000147