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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind-Body Intervention 1 | Experimental | Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 1. |
|
| Mind-Body Intervention 2 | Active Comparator | Participants will receive a mind body educational based intervention to learn the techniques comprising intervention 2. |
|
| Usual Care | No Intervention | Participants will continue their usual care for 26 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind Body Intervention 1 | Behavioral | Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Disability | Roland Morris Disability Index (Scale 0-24 with 24 being worst) | 26 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Kukler, BA | Contact | 617-754-2885 | skukler@bidmc.harvard.edu | |
| Michael Donnino, MD | Contact | 617-754-2885 | mdonnino@bidmc.harvard.edu |
| 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 | Recruiting | Boston | Massachusetts | 02215 | United States |
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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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Mind-Body Intervention 1, Mind-Body Intervention 2 and Usual Care
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Double (Participant, Outcomes Assessor) Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Participants in Mind-Body Intervention 2 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
| 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 |
| Resolution of pain disability | Resolution of pain disability as measured by 0 or 1 on 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 |
| Resolution of back pain bothersomeness | Resolution of back pain bothersomeness as measured as 0-1 on scale 0-10 | Baseline, 4 weeks, 8 weeks, 13 weeks, 26 weeks |