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This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement: (MORE) group | Experimental |
| |
| Psychoeducation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Oriented Recovery Enhancement: (MORE) group | Behavioral | Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | assessed by the Brief pain interventory | Baseline, 8 weeks, 3 month and 6 month follow up |
| Opioid Dose | assessed through their medical record | Baseline, 8 weeks, 3 month and 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | assessed through the Brief Pain Inventory | Baseline, 8 weeks, 3 month and 6 month follow up |
| Opioid Misuse | assessed by the Current Opioid Misuse Measure (COMM) |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
Not decided yet the IPD sharing plan
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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Behavioral
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| Psychoeducation | Behavioral | Education on the neurobiology of pain, healthy eating, diet, sleep and stress |
|
| Baseline, 8 weeks, 3 month and 6 month follow up |
| Opioid Withdrawal | assessed by the Opioid Withdrawal Scale (SOWS) | Baseline, 8 weeks, 3 month and 6 month follow up |
| Opioid Craving | assessed by the single item Opioid Craving | Baseline,8 weeks, 3 month and 6 month follow up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |