Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection
- Conditions
- Carpal Tunnel Syndrome
- Interventions
- Device: Ultrasound
- Registration Number
- NCT02036125
- Lead Sponsor
- Université de Sherbrooke
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound guided injection Ultrasound Ultrasound guided injection of 40 mg of methylprednisolone Ultrasound guided injection methylprednisolone Ultrasound guided injection of 40 mg of methylprednisolone Blind injection methylprednisolone Blind injection of 40 mg of methylprednisolone
- Primary Outcome Measures
Name Time Method Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale 3 months The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
- Secondary Outcome Measures
Name Time Method DASH questionnaire 3 months Ultrasound measured medial nerve area in carpal tunnel 3 months Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale 3 months The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
Numeric Pain Rating Scale Baseline Pain during injection
Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel 3 months Ultrasound hypervascularisation of medial nerve in carpal tunnel 3 months Global Rating of Change 3 months The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada