Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Physiological parameter
研究概览
简要总结
neural exercise in patients with carpal tunnel syndrome
详细描述
OBJECTIVE
The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.
STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.
METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve
排除标准
- •Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy
研究组 & 干预措施
Neural mobilization
passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
干预措施: Surgery (Procedure)
Neural mobilization
passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
干预措施: Surgery and neural mobilization (Procedure)
Surgery
the surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients.
干预措施: Neural Mobilization (Procedure)
Surgery
the surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients.
干预措施: Surgery and neural mobilization (Procedure)
Surgery and Neural mobilization
the surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group.
干预措施: Neural Mobilization (Procedure)
Surgery and Neural mobilization
the surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group.
干预措施: Surgery (Procedure)
结局指标
主要结局
Physiological parameter
时间窗: Change from Baseline Conditioned pain modulation at 6 months
Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test
次要结局
- Neuropathic pain(Baseline and 6 months)
- Pain intensity(Baseline and 6 months)
- Pain expansion(Change from baseline and 6 months)
- Pressure pain threshold(Baseline and 6 months)
- Psychological factors_Anxiety(Baseline and 6 months)
- Psychological factors_Depression(Baseline and 6 months)
- Psychological factors_Kinesiophobia(Baseline and 6 months)
- Psychological factors_catastrophizing(Baseline and 6 months)
- Psychological factors_Fear avoidance(Baseline and 6 months)
- Strength_grip(Baseline and 6 months)
- Disability_DASH(Baseline and 6 months)
- Disability_BOSTON(Baseline and 6 months)
- Strength_pinch(Baseline and 6 months)
研究者
Josue Fernandez Carnero
Professor
Universidad Rey Juan Carlos