Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Pain Syndrome Clinical Trial

— SCENAR1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755817
• Other study ID #: 2017015F
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: November 21, 2020

Study information

• Verified date: January 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2020
• Est. primary completion date: November 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• SCENAR application
Active SCENAR application on the painful area
• SCENAR application with the device off
Placebo SCENAR application on the painful area

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Collection of possible side effects	Open question	1 day