Clinical trial NCT02036125: Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection
Official title: Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Corticosteroid
Ultrasound
Guided injection
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
timeFrame: 3 months
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
timeFrame: 3 months
measure: DASH questionnaire
timeFrame: 3 months
measure: Numeric Pain Rating Scale
timeFrame: 3 months
measure: Ultrasound measured medial nerve area in carpal tunnel
timeFrame: 3 months
measure: Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel
timeFrame: 3 months
measure: Ultrasound hypervascularisation of medial nerve in carpal tunnel
timeFrame: 3 months
measure: Numeric Pain Rating Scale
timeFrame: Baseline
measure: Global Rating of Change
timeFrame: 3 months
Other outcomes:
measure: Trial group assignment - Patient
timeFrame: 3 months
measure: Trial group assignment - Assessor
timeFrame: 3 months
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Alessandra Bruns, Md, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: