Carpal Tunnel Syndrome
Conditions
Keywords
Corticosteroid, Ultrasound, Guided injection
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.
Interventions
DEVICEUltrasound
Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.
DRUGmethylprednisolone
Subjects will receive a blind injection of 40 mg of methylprednisolone.
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| DASH questionnaire | 3 months | — |
| Numeric Pain Rating Scale | 3 months | Mean pain felt in the last 2 weeks |
| Ultrasound measured medial nerve area in 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. |
| Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trial group assignment - Patient | 3 months | Questionnaire to verify patient's beliefs regarding his group allocation at follow-up. |
| Trial group assignment - Assessor | 3 months | Questionnaire to verify assessor's beliefs regarding a patient group allocation at follow-up. |
Countries
Canada
Contacts
Primary ContactAlessandra Bruns, MD, FRCPC
Backup ContactAnne-Marie Pitre-Joyal, MD
Outcome results
None listed