Randomized, two paralel groups, open clinical trial stratified by severity to stimate the cost-effectivity of surgical vs corticosteroid injection treatment on carpal tunnel syndrome

• Conditions: Carpal tunnel syndrome; MedDRA version: 14.1Level: PTClassification code 10007697Term: Carpal tunnel syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000873-56-ES
• Lead Sponsor: Federico Diaz González

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-20
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Informed consent
2.Patients between 18 and 65 able to answer written questionnaires

3.To satisfy one or more of the following symptoms: pain, paresthesias and / or hypoesthesia in the territory of the median nerve in hands

4.Nerve conduction delay in the electromyogram (EMG)

5.If the patient has bilateral clinically confirmed by EMG, the hand included will be choose by the patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.Patients with Known thyroid disease, rheumatic diseases, diabetes, polyneuropathy, renal chronic failure or alcoholism.

2.Patients who where treated previously with corticoid injection in the affected hand.
3.Patients with any pathology in the affected limb of carpal tunnel syndrome (CTS)
4.Patients with suggestive clinical cervicobraquialgias or nerve compression at any other levels.

5.Presence of thenar atrophy or irreversible injury on the median nerve(nerve conduction absence measured by EMG)

6.Contraindication to treatment with corticosteroids (Systemic fungal infection or hypersensitivity to corticosteroids or other components of the injection)

7.Patients with any contraindication to surgery.

8.Serious psychiatric condition.

9.Evidence of uncontrolled concomitant serious illness.

10.Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To Know what treatment surgical or local steroid injection is more cost effective accordingly to the severity of carpal tunnel syndrome (mild, moderate, severe);Secondary Objective: 1) To describe and analyze the costs of treating patients with STC in this study.<br>2) To study the complications of both treatments and try to establish causality in order to avoid complications in the future.<br>3) To assess the specificity and sensitivity of screening and diagnostic tests of CTS.;Primary end point(s): Effectiveness (quality of life: test DASH)<br>Direct costs;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effectiveness: quality of life by Boston test.<br>Physical examination: Dermal sensitivity (Weber test), trigger tests, hand force, wrist mobility, complications , time to return to daily activity, adverse events,;Timepoint(s) of evaluation of this end point: 12 months