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

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

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

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Ultrasound; Drug: methylprednisolone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • Centre Hospitalier Universitaire de Sherbrooke
      • Contact: Alessandra Bruns, MD, FRCPC; Phone Number: 819 564 5261
      • Contact: Anne-Marie Pitre-Joyal, MD; Phone Number: 5751 418 649 0252

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guided injection; Ultrasound guided injection of 40 mg of methylprednisolone	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.
Active Comparator: Blind injection; Blind injection of 40 mg of methylprednisolone	Drug: methylprednisolone; Subjects will receive a blind injection of 40 mg of methylprednisolone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
DASH questionnaire		3 months
Numeric Pain Rating Scale	Mean pain felt in the last 2 weeks	3 months
Ultrasound measured medial nerve area in carpal tunnel		3 months
Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel		3 months
Ultrasound hypervascularisation of medial nerve in carpal tunnel		3 months
Numeric Pain Rating Scale	Pain during injection	Baseline
Global Rating of Change	The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial group assignment - Patient	Questionnaire to verify patient's beliefs regarding his group allocation at follow-up.	3 months
Trial group assignment - Assessor	Questionnaire to verify assessor's beliefs regarding a patient group allocation at follow-up.	3 months

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Alessandra Bruns, Md, FRCPC, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 11, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 13, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Ultrasound; Corticosteroid; Guided injection
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 13-143