Cervicalgia, Chronic Pain, Neck Pain
Conditions
Keywords
Cervicalgia, SCENAR, Electrotherapy
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.
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
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.
The SCENAR device will be applied to the painful cervical area without deliver electrical impulses.
Sponsors
Study design
Intervention model description
Randomized, single-blind
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Neck Disability Index (NDI) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
| 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) | 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. |
| Patient Global Impression of Change (PGIC) score | 2 weeks after the last SCENAR session (approximately 10 weeks after baseline) | 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. |
| Treatment adherence measured by the number of completed SCENAR sessions | From baseline to the end of the treatment period (10 weeks) | 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. |
| Treatment response defined as a ≥10% reduction in Neck Disability Index (NDI) score | Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline) | 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. |
| Dispositional optimism measured by the Life Orientation Test-Revised (LOT-R) | Baseline | Dispositional optimism assessed using the Life Orientation Test-Revised (LOT-R) questionnaire. The LOT-R score is used as a predictor of treatment response. |
| Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) | Baseline | Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS) questionnaire. The PCS score is used as a predictor of treatment response. |
| Social deprivation measured by the EPICES (Evaluation de la Precarite et des Inegalites de sante dans les Centres d'Examens de Santé) questionnaire | Baseline | Social deprivation assessed using a social deprivation questionnaire. The score is used as a predictor of treatment response. |
Countries
France
Contacts
Hôpital Foch