Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Not Applicable

Completed

• Conditions: Pain Syndrome
• Interventions: Device: SCENAR application; Device: SCENAR application with the device off

• Registration Number: NCT03755817
• Lead Sponsor: Hopital Foch

Brief Summary

Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Primary Completion: 2020-11-21
• Study Completion: 2020-11-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scenar application	SCENAR application	Application of SCENAR device on
Scenar application with the device off	SCENAR application with the device off	Application of SCENAR device off

Primary Outcome Measures

Name	Time	Method
Efficacy on resting pain at the end of SCENAR application: NRS	30 minutes	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")

Secondary Outcome Measures

Name	Time	Method
Efficacy on pain at mobilization the end of SCENAR application: NRS	30 minutes	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")
Efficacy on anxiety on the following day: NRS	1 day	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")
Efficacy on resting pain on the following day: NRS	1 day	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")
Efficacy on the sensation of spinal blockage on the following day: NRS	1 day	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")
Collection of possible side effects	1 day	Open question
Efficacy on anxiety the end of SCENAR application: NRS	30 minutes	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")
Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS	30 minutes	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")
Efficacy on pain at mobilization on the following day: NRS	1 day	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")

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France