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| ID | Type | Description | Link |
|---|---|---|---|
| 2014A013 08-39 | Registry Identifier | N°IDRCB |
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| Name | Class |
|---|---|
| Hôpitaux Universitaires Paris Ile-de-Franc Ouest | OTHER |
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This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.
This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each.
During the 38 week duration of the study, enrolled patients will be assessed at:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrotactile stimulation | Experimental | Patients in this arm will have
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| Sham Stimulation with Vibradol device switched off | Sham Comparator | Patients in this arm will have
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| Standard Medical treatment | Other | Observational group, treated as usually by medications and rehabilitation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Medical treatment | Other | Standard treatment with drugs and usual rehabilitation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of baseline in reduction of surface of allodynia area | Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area | At baseline, each week during the 10 week treatment period and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of baseline in reduction of pain | Reduction of pain will be evaluated by QDSA questionnaire. | At baseline, at each week, at 10 weeks and at 6 months |
| Change of baseline in reduction of allodynia intensity |
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Eligibility Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rania Belmahfoud, MD | CRRF La Chataigneraie Convention | Study Chair |
| Valérie Zingale | CRRF La Chataigneraie Convention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRRF La Chataigneraie Convention | Paris | ÃŽle-de-France Region | 75015 | France |
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| Vibrotactile stimulation | Device | Rehabilitation by vibrotactile stimulation at medical center |
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| Sham Stimulation with Vibradol device switched off | Device | Sham Rehabilitation at medical center but with Vibradol device switched off |
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Reduction of allodynia intensity will be measured with the method with the colors
| At baseline, at each week, at 10 weeks and at 6 months |
| Change of baseline of patient's satisfaction with regard to received care | Patient's satisfaction with regard to pain relief will be evaluated by VAS | At baseline, at each week, at 10 weeks and at 6 months |
| Analgesics consumption | Amount of analgesic drugs | At 6 months |
| Afterglow effect | An evaluation of static mechanical allodynia in surface and intensity at 6 months | At 6 months |
| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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