Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

NCT03755817 | Completed

• 1 other identifier: 2017015F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Syndrome

Keywords

Spinal pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Efficacy on pain at mobilization the end of SCENAR application: NRS

  30 minutes

• Efficacy on anxiety the end of SCENAR application: NRS

  30 minutes

• Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS

  30 minutes

• Efficacy on resting pain on the following day: NRS

  1 day

• Efficacy on pain at mobilization on the following day: NRS

  1 day

Study Arms (2)

Scenar application

EXPERIMENTAL

Application of SCENAR device on

Device: SCENAR application

Scenar application with the device off

PLACEBO COMPARATOR

Application of SCENAR device off

Device: SCENAR application with the device off

Interventions

SCENAR application DEVICE

Active SCENAR application on the painful area

Scenar application

SCENAR application with the device off DEVICE

Placebo SCENAR application on the painful area

Scenar application with the device off

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Marc Fischler, MD PhD

  Hopital Foch

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 14, 2018
• Primary Completion: November 21, 2020
• Study Completion: November 21, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)