SCENAR Therapy in Chronic Non-specific Neck Pain

Official title

Assessment of the Efficacy of SCENAR Therapy in the Management of Chronic Non-specific Neck Pain

Overview

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.

Interventions

• Device Active SCENAR device therapy
  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.
• Device Sham SCENAR device Therapy
  The SCENAR device will be applied to the painful cervical area without deliver electrical impulses.

Primary outcome measures

• 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)]

Secondary outcome measures (9)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Inability to understand French
• Adults under legal protection
• Individuals deprived of liberty or under guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

France · 1 center

• Hôpital Foch — Suresnes

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. PMID 34884273
• 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 11701584
• 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 30915982
• 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 9486002
• 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 11887120

Identifiers

NCT: NCT07742228 · 2025_0061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗