CervicalgiaC-ScenarNCT07742228
SCENAR Therapy in Chronic Non-specific Neck Pain
A study testing Active SCENAR device therapy in people with Cervicalgia and Neck Pain, run by Hopital Foch at 1 site in France.
Trial summary
Shifting away from a medication-centered approach is a major public health priority, particularly in chronic pain management, where non-pharmacological therapies are recommended despite barriers such as limited evidence and low prescriber awareness. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervicalgia, Neck Pain, Chronic Pain
- What is being tested?
- Active SCENAR device therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 participants aged 18 years or older
- Patients with chronic non-specific cervical spine pain, including cervicobrachial neuralgia, persisting for at least 3 months, with no identifiable underlying cause requiring specific treatment.
- Patients who attended a pain clinic consultation or were referred to a pain specialist during hospitalization.
- Neck Disability Index (NDI) score of at least 30% (≥15 points).
- Written informed consent provided prior to study participation.
- Patient affiliated to a national health insurance
Who cannot join
- Pregnant women
- Skin conditions preventing SCENAR use (wounds, recent scars, skin infections)
- Initiation or change of analgesic treatment within 15 days prior to inclusion or during the study
- Cervical pain related to inflammatory (spondyloarthropathy, rheumatoid arthritis, chondrocalcinosis), traumatic (fractures, dislocations), tumor-related (metastases, myeloma), infectious (spondylodiscitis), or neurological (intramedullary or posterior fossa tumor) causes
- Previous SCENAR or ECOMODYN session
- Implanted pacemaker or defibrillator
Show all 9Show fewer
- Inability to understand French
- Adults under legal protection
- Individuals deprived of liberty or under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Foch
Suresnes, Île-de-France Region, 92150
Mireille Michel-Cherqui, MD, 01 46 25 29 85 ext. +33, m.michel-cherqui@hopital-foch.com
Marjolaine Ngollo, PhD, 01 46 25 37 49 ext. +33, drci-promotion@hopital-foch.com
About this study
Official title: Assessment of the Efficacy of SCENAR Therapy in the Management of Chronic Non-specific Neck Pain
Shifting away from a medication-centered approach is a major public health priority, particularly in chronic pain management, where non-pharmacological therapies are recommended despite barriers such as limited evidence and low prescriber awareness.
SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation), an electrotherapy device, lacks robust randomized controlled trial data. A prior study showed effects in both active and placebo groups after a single session, supporting further investigation.
This study aims to assess whether repeated SCENAR sessions improve disability, mobility, and pain in patients with chronic neck pain.
Read the detailed description
Reducing reliance on drug-centered care has become an important public health objective, particularly in the management of chronic pain conditions, where non-pharmacological interventions are increasingly recommended as first-line or long-term strategies. However, their implementation remains limited due to several factors, including strong cultural attachment to pharmacological treatments, insufficient practitioner awareness, and the relatively weak level of clinical evidence supporting some approaches.
Health authorities emphasize the need for well-designed comparative and cost-effectiveness studies to better evaluate these interventions in specific clinical contexts. Among such approaches, electrotherapy techniques, including transcutaneous electrical stimulation, have been previously assessed for the management of refractory pain, although evidence remains heterogeneous.
SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation) is a more recent electrotherapeutic device delivering variable electrical impulses through the skin, with proposed local effects on microcirculation and broader effects on physiological regulation systems. While some descriptive studies, mainly from non-English literature, have explored its mechanisms, high-quality randomized controlled trials are still largely lacking.
Preliminary work, on chronic spinal pain, reported similar outcomes in active and sham conditions after a single session, highlighting the need for further investigation using more intensive treatment protocols. Given manufacturer recommendations suggesting multiple sessions for clinical effect and the absence of formal guidelines, further randomized evaluation is warranted.
This study therefore investigates the effects of a five-session SCENAR protocol in patients with chronic cervical pain, with the hypothesis that it may reduce pain intensity, improve functional capacity, and decrease associated disability over time.
- Conditions
- Cervicalgia, Neck Pain, Chronic Pain
- Being tested
- Active SCENAR device therapy, Sham SCENAR device Therapy
- Keywords
- Cervicalgia, SCENAR, Electrotherapy
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SCENAR device therapyDevice
The session consists of applying the SCENAR device to the neck and surrounding cervical muscles.The device will be moved over the painful cervical area, with intensity adjusted according to patient feedback, in non-invasive sessions typically lasting 20 minutes.
Sham SCENAR device TherapyDevice
The SCENAR device will be applied to the painful cervical area without deliver electrical impulses.
| Study group | Role | What they receive |
|---|---|---|
| Active SCENAR device therapy | Experimental | Five sessions of active therapy administered to the painful cervical area using the SCENAR device. Receives: Device: Active SCENAR device therapy |
| Sham SCENAR device Therapy | Sham comparator | Participants will receive five sham SCENAR therapy sessions. The SCENAR device will be applied to the painful cervical area following the same procedure as the active intervention, but with no electrical stimulation delivered. Receives: Device: Sham SCENAR device Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Neck Disability Index (NDI) score
Change from baseline in the Neck Disability Index (NDI) score, assessed using the Neck Disability Index questionnaire. The NDI score is expressed as a percentage from 0% to 100%, with higher scores indicating greater neck-related disability.
Measured: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Secondary outcomes (9)
Change from baseline in pain intensity at rest
Change from baseline in pain intensity at rest, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Change from baseline in pain intensity during movement
Change from baseline in pain intensity during movement, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Change from baseline in average pain intensity over the previous week
Change from baseline in the average pain intensity over the previous week, assessed using the Numeric Rating Scale (NRS). Pain intensity is rated from 0 ("no pain") to 10 ("worst imaginable pain"), with higher scores indicating greater pain intensity.
Measured: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Patient Global Impression of Change (PGIC) score
Patient Global Impression of Change (PGIC) score assessed 2 weeks after the last SCENAR session using a 0-to-10 numeric rating scale version of the PGIC questionnaire. Scores range from 0 ("markedly better") to 10 ("markedly worse"), with lower scores indicating greater perceived improvement.
Measured: 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Treatment adherence measured by the number of completed SCENAR sessions
Treatment adherence assessed by the number of SCENAR sessions completed during the study period. The outcome measure is expressed as the number of completed sessions.
Measured: From baseline to the end of the treatment period (10 weeks)
Treatment response defined as a ≥10% reduction in Neck Disability Index (NDI) score
Treatment response defined as a reduction of at least 10% from baseline in the Neck Disability Index (NDI) score after completion of all SCENAR sessions. The NDI score ranges from 0% to 100%, with higher scores indicating greater neck-related disability.
Measured: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Dispositional optimism measured by the Life Orientation Test-Revised (LOT-R)
Dispositional optimism assessed using the Life Orientation Test-Revised (LOT-R) questionnaire. The LOT-R score is used as a predictor of treatment response.
Measured: Baseline
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) questionnaire. The PCS score is used as a predictor of treatment response.
Measured: Baseline
Social deprivation measured by the EPICES (Evaluation de la Precarite et des Inegalites de sante dans les Centres d'Examens de Santé) questionnaire
Social deprivation assessed using a social deprivation questionnaire. The score is used as a predictor of treatment response.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start11 Mar 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CervicalgiaStudies 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
- Model description
- Randomized, single-blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742228
- Sponsor's protocol ID
- 2025_0061
- Acronym
- C-Scenar
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Michel-Cherqui M, Guirimand A, Szekely B, Kennel T, Fischler M, Le Guen M. Effects of a Single Application of ScenarTM, a Low-Frequency Modulated Electric Current Therapy, for Pain Relief in Patients with Low Back and Neck Pain: A Randomized Single Blinded Trial. J Clin Med. 2021 Nov 26;10(23):5570. doi: 10.3390/jcm10235570.
PubMed 34884273Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
PubMed 11701584Vase L, Wartolowska K. Pain, placebo, and test of treatment efficacy: a narrative review. Br J Anaesth. 2019 Aug;123(2):e254-e262. doi: 10.1016/j.bja.2019.01.040. Epub 2019 Mar 20.
PubMed 30915982McEntegart A, Morrison E, Capell HA, Duncan MR, Porter D, Madhok R, Thomson EA. Effect of social deprivation on disease severity and outcome in patients with rheumatoid arthritis. Ann Rheum Dis. 1997 Jul;56(7):410-3. doi: 10.1136/ard.56.7.410.
PubMed 9486002Wlodyka-Demaille S, Poiraudeau S, Catanzariti JF, Rannou F, Fermanian J, Revel M. French translation and validation of 3 functional disability scales for neck pain. Arch Phys Med Rehabil. 2002 Mar;83(3):376-82. doi: 10.1053/apmr.2002.30623.
PubMed 11887120
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of SCENAR Therapy in the Management of Chronic Non-specific Neck Pain
- ClinicalTrials.gov ID
- NCT07742228
- Acronym / sponsor ID
- C-Scenar / 2025_0061
- Conditions
- Cervicalgia, Neck Pain, Chronic Pain
- Keywords
- Cervicalgia, SCENAR, Electrotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
Shifting away from a medication-centered approach is a major public health priority, particularly in chronic pain management, where non-pharmacological therapies are recommended despite barriers such as limited evidence and low prescriber awareness.
SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation), an electrotherapy device, lacks robust randomized controlled trial data. A prior study showed effects in both active and placebo groups after a single session, supporting further investigation.
This study aims to assess whether repeated SCENAR sessions improve disability, mobility, and pain in patients with chronic neck pain.
Detailed description
Reducing reliance on drug-centered care has become an important public health objective, particularly in the management of chronic pain conditions, where non-pharmacological interventions are increasingly recommended as first-line or long-term strategies. However, their implementation remains limited due to several factors, including strong cultural attachment to pharmacological treatments, insufficient practitioner awareness, and the relatively weak level of clinical evidence supporting some approaches.
Health authorities emphasize the need for well-designed comparative and cost-effectiveness studies to better evaluate these interventions in specific clinical contexts. Among such approaches, electrotherapy techniques, including transcutaneous electrical stimulation, have been previously assessed for the management of refractory pain, although evidence remains heterogeneous.
SCENAR (Self-Controlled Energo-Neuro Adaptive Regulation) is a more recent electrotherapeutic device delivering variable electrical impulses through the skin, with proposed local effects on microcirculation and broader effects on physiological regulation systems. While some descriptive studies, mainly from non-English literature, have explored its mechanisms, high-quality randomized controlled trials are still largely lacking.
Preliminary work, on chronic spinal pain, reported similar outcomes in active and sham conditions after a single session, highlighting the need for further investigation using more intensive treatment protocols. Given manufacturer recommendations suggesting multiple sessions for clinical effect and the absence of formal guidelines, further randomized evaluation is warranted.
This study therefore investigates the effects of a five-session SCENAR protocol in patients with chronic cervical pain, with the hypothesis that it may reduce pain intensity, improve functional capacity, and decrease associated disability over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind
| Arm | Type | Receives |
|---|---|---|
| Active SCENAR device therapy | Experimental | Device: Active SCENAR device therapyFive sessions of active therapy administered to the painful cervical area using the SCENAR device. |
| Sham SCENAR device Therapy | Sham comparator | Device: Sham SCENAR device TherapyParticipants will receive five sham SCENAR therapy sessions. The SCENAR device will be applied to the painful cervical area following the same procedure as the active intervention, but with no electrical stimulation delivered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participants aged 18 years or older
- Patients with chronic non-specific cervical spine pain, including cervicobrachial neuralgia, persisting for at least 3 months, with no identifiable underlying cause requiring specific treatment.
- Patients who attended a pain clinic consultation or were referred to a pain specialist during hospitalization.
- Neck Disability Index (NDI) score of at least 30% (≥15 points).
- Written informed consent provided prior to study participation.
Key exclusion criteria (9 listed)
- Pregnant women
- Skin conditions preventing SCENAR use (wounds, recent scars, skin infections)
- Initiation or change of analgesic treatment within 15 days prior to inclusion or during the study
- Cervical pain related to inflammatory (spondyloarthropathy, rheumatoid arthritis, chondrocalcinosis), traumatic (fractures, dislocations), tumor-related (metastases, myeloma), infectious (spondylodiscitis), or neurological (intramedullary or posterior fossa tumor) causes
- Previous SCENAR or ECOMODYN session
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 |
|---|---|---|
| Active SCENAR device therapyThe session consists of applying the SCENAR device to the neck and surrounding cervical muscles.The device will be moved over the painful cervical area, with intensity adjusted according to patient feedback, in non-invasive sessions typically lasting 20 minutes. | Device | Active SCENAR device therapy |
| Sham SCENAR device TherapyThe SCENAR device will be applied to the painful cervical area without deliver electrical impulses. | Device | Sham SCENAR device Therapy |
Primary outcome
Change from baseline in Neck Disability Index (NDI) score
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Change from baseline in the Neck Disability Index (NDI) score, assessed using the Neck Disability Index questionnaire. The NDI score is expressed as a percentage from 0% to 100%, with higher scores indicating greater neck-related disability.
9 secondary outcomes
Change from baseline in pain intensity at rest
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Change from baseline in pain intensity during movement
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Change from baseline in average pain intensity over the previous week
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Patient Global Impression of Change (PGIC) score
Time frame: 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Treatment adherence measured by the number of completed SCENAR sessions
Time frame: From baseline to the end of the treatment period (10 weeks)
Treatment response defined as a ≥10% reduction in Neck Disability Index (NDI) score
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
Dispositional optimism measured by the Life Orientation Test-Revised (LOT-R)
Time frame: Baseline
Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Social deprivation measured by the EPICES (Evaluation de la Precarite et des Inegalites de sante dans les Centres d'Examens de Santé) questionnaire
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 34884273Michel-Cherqui M, Guirimand A, Szekely B, Kennel T, Fischler M, Le Guen M. Effects of a Single Application of ScenarTM, a Low-Frequency Modulated Electric Current Therapy, for Pain Relief in Patients with Low Back and Neck Pain: A Randomized Single Blinded Trial. J Clin Med. 2021 Nov 26;10(23):5570. doi: 10.3390/jcm10235570.
- Results publication: PubMed 11701584Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
- Results publication: PubMed 30915982Vase L, Wartolowska K. Pain, placebo, and test of treatment efficacy: a narrative review. Br J Anaesth. 2019 Aug;123(2):e254-e262. doi: 10.1016/j.bja.2019.01.040. Epub 2019 Mar 20.
- Results publication: PubMed 9486002McEntegart A, Morrison E, Capell HA, Duncan MR, Porter D, Madhok R, Thomson EA. Effect of social deprivation on disease severity and outcome in patients with rheumatoid arthritis. Ann Rheum Dis. 1997 Jul;56(7):410-3. doi: 10.1136/ard.56.7.410.
- Results publication: PubMed 11887120Wlodyka-Demaille S, Poiraudeau S, Catanzariti JF, Rannou F, Fermanian J, Revel M. French translation and validation of 3 functional disability scales for neck pain. Arch Phys Med Rehabil. 2002 Mar;83(3):376-82. doi: 10.1053/apmr.2002.30623.
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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.
Mireille Michel-Cherqui, MD principal investigator
Hôpital 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 Active SCENAR device therapy in people with Cervicalgia and Neck Pain, 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireille Michel-Cherqui, MD (01 46 25 29 85 ext. +33, m.michel-cherqui@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Neck Disability Index (NDI) score (time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07742228, which also lists 5 linked publications.
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 3 Aug 2026.