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| ID | Type | Description | Link |
|---|---|---|---|
| REB: B2007:129 | |||
| Impact: RI07:119 | |||
| Health Canada: 116697 |
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| Name | Class |
|---|---|
| Valeant Canada Limited | INDUSTRY |
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The purpose of this proposed study is to conduct a randomized double-blind placebo controlled trial assessing the benefit of nabilone in pain management and improvement of quality of life in patients with phantom limb pain.
Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the phantom limb pain and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the Groningen Sleep Quality Scale and daily prosthetic wearing time.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone | Drug | Nabilone 0.5 mg at hs for 1 week, then 0.5 mg BID for 1 week. After a reassessment of the outcome measures, the dose is increased to 0.5 mg in the morning and 1 mg at hs for 1 week, followed by an increase to 1 mg BID in the last week of the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for Pain | Baseline, 2, 4 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Anxiety and Stress Scale | Baseline, 2, 4 and 6 weeks | |
| Groningen Sleep Quality Scale | Baseline, 2, 4 and 6 weeks | |
| SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Q Skrabek, MD, FRCPC | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Hospital | Winnipeg | Manitoba | R3A 1M4 | Canada |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D009437 | Neuralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| Baseline, 2, 4 and 6 weeks |
| Frequency of phantom limb pain | Baseline, 2, 4 and 6 weeks |
| Daily prosthetic wearing time | Baseline, 2, 4 and 6 weeks |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |