Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome

Conditions
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Pain Syndrome

Intervention / Treatment
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* Device: SCENAR application
* Device: SCENAR application with the device off


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 18 and under 80 years of age Suffering of common spinal pain: cervical pain including cervico-brachial neuralgia, lumbar pain including lumbo-radiculalgia Having attended a pain consultation or referred to a pain consultant during hospitalization Having signed the consent form Can be contacted directly by phone if patient is not hospitalized Be affiliated to a national insurance scheme or benefiting from such a program Non-inclusion Criteria: Pregnant or breast-feeding women Patients with a pacemaker Patients whose skin condition makes the use of SCENAR impossible (wounds, recent scars, skin infections) Patient whose spinal pain is known to be related to inflammatory pathology (spondylarthropathy, rheumatoid arthritis, chondrocalcinosis), trauma (fractures and dislocations), tumor (metastases, myeloma localization), spondylodiscitis infectious, neurological (intrarachidian tumor or posterior fossa) or radiculalgia with deficient signs Patients who have already had a SCENAR session Patients who have already participated in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scenar application<br>Application of SCENAR device on | Device: SCENAR application<br>* Active SCENAR application on the painful area<br>|
| Placebo Comparator: Scenar application with the device off<br>Application of SCENAR device off | Device: SCENAR application with the device off<br>* Placebo SCENAR application on the painful area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal pain