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

H

Hopital Foch

Status

Completed

Conditions

Pain Syndrome

Treatments

Device: SCENAR application with the device off
Device: SCENAR application

Study type

Interventional

Funder types

Other

Identifiers

NCT03755817
2017015F

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

Scenar application
Experimental group
Description:
Application of SCENAR device on
Treatment:
Device: SCENAR application
Scenar application with the device off
Placebo Comparator group
Description:
Application of SCENAR device off
Treatment:
Device: SCENAR application with the device off

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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