Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Hopital Foch60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain Syndrome

Interventions

SCENAR applicationDEVICE

Active SCENAR application on the painful area

SCENAR application with the device offDEVICE

Placebo SCENAR application on the painful area

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Foch

Suresnes, France

Outcomes

Primary Outcomes

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")

Time frame: 30 minutes

Secondary Outcomes

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")

Time frame: 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")

Time frame: 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")

Time frame: 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")

Time frame: 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")

Data from ClinicalTrials.gov

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