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neural exercise in patients with carpal tunnel syndrome
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neural mobilization | Experimental | passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand |
|
| Surgery | Active Comparator | 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. |
|
| Surgery and Neural mobilization | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neural Mobilization | Procedure | neural exercise Will be performed in the patients |
|
| 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 |
| 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). |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josué Fernández, PhD | Contact | 34914888949 | josue.fernandez@urjc.es | |
| Luis Matesanz | Contact | 675042482 | luis.matesanzgarcia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rey Juan Carlos | Recruiting | AlcorcĂłn | Madrid | 28922 | Spain |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome |
|
| Surgery and neural mobilization | Procedure | following the surgery patients will be treat with neural mobilization exercises. |
|
| 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |