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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
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.
Hôpital Foch
Suresnes, Île-de-France Region, France
RECRUITINGChange 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.
Time frame: Baseline and 2 weeks after the last SCENAR session (approximately 10 weeks after baseline)
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
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
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.
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)
Dispositional optimism assessed using the Life Orientation Test-Revised (LOT-R) questionnaire. The LOT-R score is used as a predictor of treatment response.
Time frame: 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.
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
Social deprivation assessed using a social deprivation questionnaire. The score is used as a predictor of treatment response.
Time frame: Baseline
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