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

Carpal Tunnel Syndrome Clinical Trial

— STC-EI  

Official title:

Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02036125
• Other study ID #: 13-143
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2014
• Last updated: December 13, 2014
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: Université de Sherbrooke
• Contact: Alessandra Bruns, MD, FRCPC
• Phone: 819 564 5261
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Ultrasound
Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.

Drug:
• methylprednisolone
Subjects will receive a blind injection of 40 mg of methylprednisolone.

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Trial group assignment - Patient	Questionnaire to verify patient's beliefs regarding his group allocation at follow-up.	3 months	No
Other	Trial group assignment - Assessor	Questionnaire to verify assessor's beliefs regarding a patient group allocation at follow-up.	3 months	No
Primary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	DASH questionnaire		3 months	No
Secondary	Numeric Pain Rating Scale	Mean pain felt in the last 2 weeks	3 months	No
Secondary	Ultrasound measured medial nerve area in carpal tunnel		3 months	No
Secondary	Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel		3 months	No
Secondary	Ultrasound hypervascularisation of medial nerve in carpal tunnel		3 months	No
Secondary	Numeric Pain Rating Scale	Pain during injection	Baseline	Yes
Secondary	Global Rating of Change	The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.	3 months	No