Evaluation of a Conservative Treatment by Nocturnal Wrist Orthosis in the Non-surgical Management of Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
研究概览
简要总结
This study focuses on the evaluation of 2 nocturnal wrist orthosis prescribed as part of a non-surgical management of carpal tunnel syndrome in order to determine their effectiveness in reducing the symptoms associated with the syndrome and to highlight the superiority or the inferiority of one over the other.
It will also be possible to assess their comfort and compliance as well as the impact of wearing them on neurological and muscular recovery (functional assessment).
详细描述
After selection of patients suffering from carpal tunnel syndrome during consultation visits, the study will be explained to them, an information sheet and a consent form will be given to them.
A subgroup of patients who have undergone a diagnostic electromyogram at the study center (defined as a functional assessment subgroup) will be randomized independently of the other participants (2 randomization lists will be generated).
The randomization will be done on 2 groups: one benefiting from a wrist orthosis called simple rest, and the other from a wrist-hand-finger orthosis called global rest.
An appointment for making the orthosis will be fixed with the manufacturer within one month of inclusion.
The follow-up will then be done by 2 telephone collection visits at 1 month then at 2 months of the implementation of the device then by a last visit at 3 months consisting in a consultation for the functional assessment subgroup and a phone call for the others.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with unilateral or bilateral, idiopathic or secondary carpal tunnel syndrome, without surgical indication (EMG with myelin sensory signs without axonal involvement)
- •signed consent
- •Affiliation to social security
排除标准
- •Patients with carpal tunnel syndrome with severity criteria
- •Patient refusal
- •Patient with disorders (psychological, behavioral) that may lead to poor compliance with the study treatment
- •Presence of skin lesion in the area of the orthosis
- •Current participation in another research protocol involving the human person
研究组 & 干预措施
wrist orthosis
group benefiting from an orthosis that supports the wrist by covering the palm of the hand only
干预措施: Nocturnal wrist orthosis wearing (Device)
wrist-hand-finger orthosis
group benefiting from an orthosis that supports the wrist by covering the palm of the hand and the fingers
干预措施: Nocturnal wrist orthosis wearing (Device)
结局指标
主要结局
Measure and compare the evolution over time of the effectiveness of the 2 nocturnal orthoses
时间窗: Orthosis implementation, 1 month and 3 months after orthosis implementation
Score of Boston Carpal Tunnel Syndrome Questionnaire : SEVERITY SCALE OF SYMPTOMS (11 ITEMS): score from 1 to 5 (each item) + FUNCTIONAL EVALUATION SCALE (8 ITEMS): score from 1 to 5 (each item). Higher score means worse outcome.
次要结局
- Evaluate the failure rate of treatment with nocturnal orthosis(3 months after orthosis implementation)
- Muscle strength recovery(Inclusion and 3 months after orthosis implementation)
- Compare the patient's compliance with wearing the 2 types of nocturnal orthosis(1 month and 3 months after orthosis implementation)
- Compare the comfort of the 2 types of nocturnal orthosis(1 month and 3 months after orthosis implementation)
- Evaluate the impact of the precocity of the conservative treatment on its effectiveness(1 month and 3 months after orthosis implementation)
- Neurological recovery(Inclusion and 3 months after orthosis implementation)