NCT07742228

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Jul 2028

Study Start

First participant enrolled

March 11, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

June 9, 2026

Last Update Submit

July 29, 2026

Conditions

CervicalgiaNeck PainChronic Pain

Keywords

CervicalgiaSCENARElectrotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)

  • Change from baseline in pain intensity during movement

    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

    Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)

  • Patient Global Impression of Change (PGIC) score

    2 weeks after the last SCENAR session (approximately 10 weeks after baseline)

  • Treatment adherence measured by the number of completed SCENAR sessions

    From baseline to the end of the treatment period (10 weeks)

  • +4 more secondary outcomes

Study Arms (2)

Active SCENAR device therapy

EXPERIMENTAL

Five sessions of active therapy administered to the painful cervical area using the SCENAR device.

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.

Device: Sham SCENAR device Therapy

Interventions

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.

Active SCENAR device therapy
Sham SCENAR device TherapyDEVICE

The SCENAR device will be applied to the painful cervical area without deliver electrical impulses.

Sham SCENAR device Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women
  • Skin conditions preventing SCENAR use (wounds, recent scars, skin infections)
  • 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
  • Inability to understand French
  • Adults under legal protection
  • Individuals deprived of liberty or under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, Île-de-France Region, 92150, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34884273RESULT

  • Vickers 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.

    PMID: 11701584RESULT

  • Vase 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.

    PMID: 30915982RESULT

  • McEntegart 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.

    PMID: 9486002RESULT

  • Wlodyka-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.

    PMID: 11887120RESULT

MeSH Terms

Conditions

Neck PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mireille Michel-Cherqui, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireille Michel-Cherqui, MD

CONTACT

01 46 25 29 85m.michel-cherqui@hopital-foch.com

Marjolaine Ngollo, PhD

CONTACT

01 46 25 37 49drci-promotion@hopital-foch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single-blind
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

August 3, 2026

Study Start

March 11, 2026

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

July 30, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations

FR(1)