Assessment of the Efficacy of SCENAR Therapy in the Management of Chronic Non-specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Hopital Foch
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline in Neck Disability Index (NDI) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in Neck Disability Index (NDI) score
时间窗: 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.
次要结局
- 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))
- 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))
- Dispositional optimism measured by the Life Orientation Test-Revised (LOT-R)(Baseline)
- Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS)(Baseline)
- Social deprivation measured by the EPICES (Evaluation de la Precarite et des Inegalites de sante dans les Centres d'Examens de Santé) questionnaire(Baseline)