Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome (SCENAR1)

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

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

Study Overview

• Status: Completed
• Conditions: Pain Syndrome
• Intervention / Treatment: Device: SCENAR application; Device: SCENAR application with the device off

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scenar application; Application of SCENAR device on	Device: SCENAR application; Active SCENAR application on the painful area
Placebo Comparator: Scenar application with the device off; Application of SCENAR device off	Device: SCENAR application with the device off; Placebo SCENAR application on the painful area

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): November 21, 2020
• Study Completion (Actual): November 21, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Spinal pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Syndrome; Somatoform Disorders
• Other Study ID Numbers: 2017015F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No