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

N/AUnknownNCT02036125

Université de Sherbrooke50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

UltrasoundDEVICE

Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.

methylprednisoloneDRUG

Subjects will receive a blind injection of 40 mg of methylprednisolone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

DASH questionnaire

Time frame: 3 months

Numeric Pain Rating Scale

Mean pain felt in the last 2 weeks

Time frame: 3 months

Ultrasound measured medial nerve area in carpal tunnel

Time frame: 3 months

Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel

Time frame: 3 months

Ultrasound hypervascularisation of medial nerve in carpal tunnel

Time frame: 3 months

Numeric Pain Rating Scale

Pain during injection

Time frame: Baseline

Global Rating of Change

The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.

Time frame: 3 months

Central Contacts

Alessandra Bruns, MD, FRCPC

CONTACT

819 564 5261

Anne-Marie Pitre-Joyal, MD

CONTACT

418 649 0252 anne-marie.joyal.2@ulaval.ca

Data from ClinicalTrials.gov

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