Pain SyndromeSCENAR1NCT03755817
Efficacy Assessment of SCENAR Device on Common Spinal Pain Syndrome
A study testing SCENAR application and SCENAR application with the device off in people with Pain Syndrome, run by Hopital Foch at 1 site in France.
Trial summary
Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- SCENAR application and SCENAR application with the device off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2018to 21 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Efficacy Assessment of SCENAR's Session on a 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.
- Conditions
- Pain Syndrome
- Being tested
- SCENAR application, SCENAR application with the device off
- Keywords
- Spinal pain
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCENAR applicationDevice
Active SCENAR application on the painful area
SCENAR application with the device offDevice
Placebo SCENAR application on the painful area
| Study group | Role | What they receive |
|---|---|---|
| Scenar application | Experimental | Application of SCENAR device on Receives: Device: SCENAR application |
| Scenar application with the device off | Placebo comparator | Application of SCENAR device off Receives: Device: SCENAR application with the device off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 30 minutes
Secondary outcomes (8)
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")
Measured: 30 minutes
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")
Measured: 30 minutes
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")
Measured: 30 minutes
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")
Measured: 1 day
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")
Measured: 1 day
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")
Measured: 1 day
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")
Measured: 1 day
Collection of possible side effects
Open question
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start14 Nov 2018
- Primary completion21 Nov 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD PhD, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755817
- Sponsor's protocol ID
- 2017015F
- Acronym
- SCENAR1
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2018
- Last updated
- 8 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome
- ClinicalTrials.gov ID
- NCT03755817
- Acronym / sponsor ID
- SCENAR1 / 2017015F
- Conditions
- Pain Syndrome
- Keywords
- Spinal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scenar application | Experimental | Device: SCENAR applicationApplication of SCENAR device on |
| Scenar application with the device off | Placebo comparator | Device: SCENAR application with the device offApplication of SCENAR device off |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCENAR applicationActive SCENAR application on the painful area | Device | Scenar application |
| SCENAR application with the device offPlacebo SCENAR application on the painful area | Device | Scenar application with the device off |
Primary outcome
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")
8 secondary outcomes
Efficacy on pain at mobilization the end of SCENAR application: NRS
Time frame: 30 minutes
Efficacy on anxiety the end of SCENAR application: NRS
Time frame: 30 minutes
Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS
Time frame: 30 minutes
Efficacy on resting pain on the following day: NRS
Time frame: 1 day
Efficacy on pain at mobilization on the following day: NRS
Time frame: 1 day
Efficacy on the sensation of spinal blockage on the following day: NRS
Time frame: 1 day
Efficacy on anxiety on the following day: NRS
Time frame: 1 day
Collection of possible side effects
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler, MD PhD study director
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCENAR application and SCENAR application with the device off in people with Pain Syndrome, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on resting pain at the end of SCENAR application: NRS (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.