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Completed

NCT Number: NCT03755817

Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

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

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Key information

Conditions

Pain Syndrome Mental Disorders Somatoform Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCENAR application

Device

Active SCENAR application on the painful area

SCENAR application with the device off

Device

Placebo SCENAR application on the painful area

Primary outcomes

  1. Efficacy on resting pain at the end of SCENAR application: NRS

    Time frame: 30 minutes

    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")

Secondary outcomes

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

    Time frame: 30 minutes

    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")

  2. Efficacy on anxiety the end of SCENAR application: NRS

    Time frame: 30 minutes

    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")

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

    Time frame: 30 minutes

    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")

  4. Efficacy on resting pain on the following day: NRS

    Time frame: 1 day

    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")

  5. Efficacy on pain at mobilization on the following day: NRS

    Time frame: 1 day

    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")

  6. Efficacy on the sensation of spinal blockage on the following day: NRS

    Time frame: 1 day

    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")

  7. Efficacy on anxiety on the following day: NRS

    Time frame: 1 day

    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")

  8. Collection of possible side effects

    Time frame: 1 day

    Open question

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: SCENAR1

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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