Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

NCT ID: NCT03755817

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2020-11-21

Brief Summary

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

Detailed Description

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Conditions

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Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Scenar application

Application of SCENAR device on

Group Type EXPERIMENTAL

SCENAR application

Intervention Type DEVICE

Active SCENAR application on the painful area

Scenar application with the device off

Application of SCENAR device off

Group Type PLACEBO_COMPARATOR

SCENAR application with the device off

Intervention Type DEVICE

Placebo SCENAR application on the painful area

Interventions

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SCENAR application

Active SCENAR application on the painful area

Intervention Type DEVICE

SCENAR application with the device off

Placebo SCENAR application on the painful area

Intervention Type DEVICE

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD PhD

Role: STUDY_DIRECTOR

Hopital Foch

Locations

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Hôpital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2017015F

Identifier Type: -

Identifier Source: org_study_id

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