Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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neural exercise in patients with carpal tunnel syndrome

Detailed Description
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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.

Official Title
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Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Procedure: Neural Mobilization
* Procedure: Surgery
* Procedure: Surgery and neural mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neural mobilization<br>passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand | Procedure: Surgery<br>* open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome<br>Procedure: Surgery and neural mobilization<br>* following the surgery patients will be treat with neural mobilization exercises.<br>|
| Active Comparator: Surgery<br>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. | Procedure: Neural Mobilization<br>* neural exercise Will be performed in the patients<br>Procedure: Surgery and neural mobilization<br>* following the surgery patients will be treat with neural mobilization exercises.<br>|
| Active Comparator: Surgery and Neural mobilization<br>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. | Procedure: Neural Mobilization<br>* neural exercise Will be performed in the patients<br>Procedure: Surgery<br>* open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological parameter | Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test | Change from Baseline Conditioned pain modulation at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain | Neuropathic pain Questionnaire DN4 | Baseline and 6 months | 
| Pain intensity | Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain). | Baseline and 6 months | 
| Pain expansion | Body pain maps | Change from baseline and 6 months | 
| Pressure pain threshold | Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted. | Baseline and 6 months | 
| Psychological factors_Anxiety | State Trait Anxiety Inventory (STAI-T) | Baseline and 6 months | 
| Psychological factors_Depression | Beck Depression Inventory (BDI-II) | Baseline and 6 months | 
| Psychological factors_Kinesiophobia | Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome. | Baseline and 6 months | 
| Psychological factors_catastrophizing | Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome. | Baseline and 6 months | 
| Psychological factors_Fear avoidance | Fear Avoidance Belief Questionnaire (FABQ) | Baseline and 6 months | 
| Disability_DASH | Disabilities of Arm, Shoulder and Hand (DASH) | Baseline and 6 months | 
| Disability_BOSTON | Boston Carpal Tunnel Questionnaire | Baseline and 6 months | 
| Strength_grip | grip strength without pain | Baseline and 6 months | 
| Strength_pinch | pinch strength | Baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain modulation, Neural mobilization, Surgery