Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection (STC-EI)

Université de Sherbrooke

Status: Unknown

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: methylprednisolone; Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02036125

13-143

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups

Ultrasound guided injection

Experimental group

Description:

Ultrasound guided injection of 40 mg of methylprednisolone

Treatment:

Drug: methylprednisolone

Device: Ultrasound

Blind injection

Active Comparator group

Description:

Blind injection of 40 mg of methylprednisolone

Treatment:

Drug: methylprednisolone