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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
INTERVENTION: Trade Name: Celestone cronodose Product Name: Betametasona Acetato, Betametasona Fosfato Sodio Pharmaceutical Form: Solution for injection INN or Proposed INN: Betamethasone Acetate CAS Number: 987‐24‐6 Other descriptive name: BETAMETHASONE ACETATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3‐ INN or Proposed INN: Betamethasone Sodium Phosphate CAS Number: 151‐73‐5 Other descriptive name: BETAMETHASONE DISODIUM PHOSPHATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3‐ CONDITION: Carpal tunnel syndrome ; MedDRA version: 14.1 Level: PT Classification code 10007697 Term: Carpal tunnel syndrome System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: 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) Primary end point(s): Effectiveness (quality of life: test DASH); Direct costs Secondary Objective: 1) To describe and analyze the costs of treating patients with STC in this study.; 2) To study the complications of both treatments and try to establish causality in order to avoid complications in the future.; 3) To assess the specificity and sensitivity of screening and diagnostic tests of CTS. Timepoint(s) of evaluation of this end point: 12 months SECONDARY OUTCOME: Secondary end point(s): Effectiveness: quality of life by Boston test.; 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 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
Epistemonikos ID: 559472ec68c4075946112c693ab8645389c81455
First added on: Aug 22, 2024