Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.

Detailed Description
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Corticosteroid injection is routinely given for treating carpal tunnel syndrome. The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome. In this randomised clinical trial, 50 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from the Centre Hospitalier Universitaire de Sherbrooke (CHUS). Subjects will be randomised to ultrasound guided or blind injection groups. All subjects will receive 40 mg of methylprednisolone. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline and 3 months post injection. Both subjects and assessors will be blinded.

Official Title
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Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: Ultrasound
* Drug: methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 Understanding written and spoken french Diagnostic of carpal tunnel syndrome : Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies Exclusion Criteria: Carpal tunnel injection in the last 6 months Constant symptoms in medial nerve area Thenar eminence atrophy Absolute contraindication to corticosteroid injection : infective arthritis, bacterial endocarditis, local cellulitis of skin infection, coagulopathy, corticosteroid or latex allergy Secondary diagnosis based on the ultrasound : arthrosynovial cyst, flexor tenosynovitis, ganglion Known cognitive disorder Anticoagulant therapy Diseases known to cause carpal tunnel syndrome : Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment Radiculopathy Polyneuropathy Pregnancy Ancient ipsilateral wrist fracture Ancient ipsilateral wrist surgery

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided injection<br>Ultrasound guided injection of 40 mg of methylprednisolone | Device: Ultrasound<br>* Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.<br>Drug: methylprednisolone<br>* Subjects will receive a blind injection of 40 mg of methylprednisolone.<br>|
| Active Comparator: Blind injection<br>Blind injection of 40 mg of methylprednisolone | Drug: methylprednisolone<br>* Subjects will receive a blind injection of 40 mg of methylprednisolone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale | The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale | The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale. | 3 months | 
| DASH questionnaire |  | 3 months | 
| Numeric Pain Rating Scale | Mean pain felt in the last 2 weeks | 3 months | 
| Ultrasound measured medial nerve area in carpal tunnel |  | 3 months | 
| Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel |  | 3 months | 
| Ultrasound hypervascularisation of medial nerve in carpal tunnel |  | 3 months | 
| Numeric Pain Rating Scale | Pain during injection | Baseline | 
| Global Rating of Change | The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corticosteroid, Ultrasound, Guided injection