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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants will continue their usual care for 26 weeks | |
| Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST) | Experimental | Participants will receive a mind body educational-based intervention to learn the techniques comprising intervention 1. Further details are not provided for blinding purposes. |
|
| Mind Body Intervention 2 | Active Comparator | Participants will receive a mind-body educational-based intervention to learn the techniques comprising intervention 2. Further details are not provided for blinding purposes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST) | Behavioral | Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
The investigators will not be sharing IPD data with researchers outside of their research group.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Usual Care, Intervention
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Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
|
| Mind Body Intervention 2 | Behavioral | Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions. |
|
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 |