NCT03755817已完成不适用
Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficacy on resting pain at the end of SCENAR application: NRS
研究概览
简要总结
Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.
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
- Single (Participant)
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 over 18 and under 80 years of age
- •Suffering of common spinal pain: cervical pain including cervico-brachial neuralgia, lumbar pain including lumbo-radiculalgia
- •Having attended a "pain consultation" or referred to a pain consultant during hospitalization
- •Having signed the consent form
- •Can be contacted directly by phone if patient is not hospitalized
- •Be affiliated to a national insurance scheme or benefiting from such a program
- •Non-inclusion Criteria:
- •Pregnant or breast-feeding women
- •Patients with a pacemaker
- •Patients whose skin condition makes the use of SCENAR impossible (wounds, recent scars, skin infections)
- •Patient whose spinal pain is known to be related to inflammatory pathology (spondylarthropathy, rheumatoid arthritis, chondrocalcinosis), trauma (fractures and dislocations), tumor (metastases, myeloma localization), spondylodiscitis infectious, neurological (intrarachidian tumor or posterior fossa) or radiculalgia with deficient signs
- •Patients who have already had a SCENAR session
- •Patients who have already participated in this study
排除标准
- 未提供
结局指标
主要结局
Efficacy on resting pain at the end of SCENAR application: NRS
时间窗: 30 minutes
Self-assessment of pain using the pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")
次要结局
- Efficacy on pain at mobilization the end of SCENAR application: NRS(30 minutes)
- Efficacy on anxiety on the following day: NRS(1 day)
- Efficacy on resting pain on the following day: NRS(1 day)
- Efficacy on the sensation of spinal blockage on the following day: NRS(1 day)
- Collection of possible side effects(1 day)
- Efficacy on anxiety the end of SCENAR application: NRS(30 minutes)
- Efficacy on the sensation of spinal blockage at the end of SCENAR application: NRS(30 minutes)
- Efficacy on pain at mobilization on the following day: NRS(1 day)
研究者
研究点 (2)
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