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Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scenar application | Experimental | Application of SCENAR device on |
|
| Scenar application with the device off | Placebo Comparator | Application of SCENAR device off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCENAR application | Device | Active SCENAR application on the painful area |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on resting pain at the end of SCENAR application: NRS | Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain") | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on pain at mobilization the end of SCENAR application: NRS | Self-assessment of pain intensity using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain") | 30 minutes |
| Efficacy on anxiety the end of SCENAR application: NRS |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Fischler, MD PhD | Hopital Foch | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| SCENAR application with the device off |
| Device |
Placebo SCENAR application on the painful area |
|
Self-assessment of anxiety using the pain numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("no anxiety") to 10 ("worst possible anxiety") |
| 30 minutes |
| Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS | Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current blockage from 0 ("complete blockage") to 10 ("perfect mobility") | 30 minutes |
| Efficacy on resting pain on the following day: NRS | Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain") | 1 day |
| Efficacy on pain at mobilization on the following day: NRS | Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain") | 1 day |
| Efficacy on the sensation of spinal blockage on the following day: NRS | Self-assessment of the sensation of spinal blockage using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("complete blockage") to 10 ("perfect mobility") | 1 day |
| Efficacy on anxiety on the following day: NRS | Self-assessment of anxiety using the numeric rating scale (NRS), on which patients rate their current anxiety from 0 ("no anxiety") to 10 ("worst possible anxiety") | 1 day |
| Collection of possible side effects | Open question | 1 day |