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

Primary Purpose

Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

SCENAR application

SCENAR application with the device off

About this trial

This is an interventional treatment trial for Pain Syndrome focused on measuring Spinal pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Scenar application

Scenar application with the device off

Arm Description

Application of SCENAR device on

Application of SCENAR device off

Outcomes

Primary Outcome Measures

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")

Secondary Outcome Measures

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")

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")

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")

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")

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")

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

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")

Efficacy on anxiety on the following day: NRS

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")

Collection of possible side effects

Open question

Full Information

NCT ID

NCT03755817

First Posted

November 26, 2018

Last Updated

January 7, 2021

Sponsor

Hopital Foch

1. Study Identification

Unique Protocol Identification Number

NCT03755817

Brief Title

Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

Acronym

SCENAR1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

November 14, 2018 (Actual)

Primary Completion Date

November 21, 2020 (Actual)

Study Completion Date

November 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain Syndrome

Keywords

Spinal pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scenar application

Arm Type

Experimental

Arm Description

Application of SCENAR device on

Arm Title

Scenar application with the device off

Arm Type

Placebo Comparator

Arm Description

Application of SCENAR device off

Intervention Type

Device

Intervention Name(s)

SCENAR application

Intervention Description

Active SCENAR application on the painful area

Intervention Type

Device

Intervention Name(s)

SCENAR application with the device off

Intervention Description

Placebo SCENAR application on the painful area

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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

Title

Efficacy on anxiety the end of SCENAR application: NRS

Description

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

Title

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

Description

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

Title

Efficacy on resting pain on the following day: NRS

Description

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

Title

Efficacy on pain at mobilization on the following day: NRS

Description

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

Title

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

Description

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")

Time Frame

1 day

Title

Efficacy on anxiety on the following day: NRS

Description

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")

Time Frame

1 day

Title

Collection of possible side effects

Description

Open question

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Fischler, MD PhD

Organizational Affiliation

Hopital Foch

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Foch

City

Suresnes

ZIP/Postal Code

92150

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome

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