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

NCT ID: NCT02036125

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Keywords

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Corticosteroid Ultrasound Guided injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ultrasound guided injection

Ultrasound guided injection of 40 mg of methylprednisolone

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.

methylprednisolone

Intervention Type DRUG

Subjects will receive a blind injection of 40 mg of methylprednisolone.

Blind injection

Blind injection of 40 mg of methylprednisolone

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

Subjects will receive a blind injection of 40 mg of methylprednisolone.

Interventions

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Ultrasound

Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.

Intervention Type DEVICE

methylprednisolone

Subjects will receive a blind injection of 40 mg of methylprednisolone.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Bruns

MD, FRCPC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Bruns, Md, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

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Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Alessandra Bruns, MD, FRCPC

Role: CONTACT

Phone: 819 564 5261

Anne-Marie Pitre-Joyal, MD

Role: CONTACT

Phone: 418 649 0252

Email: [email protected]

Facility Contacts

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Alessandra Bruns, MD, FRCPC

Role: primary

Anne-Marie Pitre-Joyal, MD

Role: backup

Other Identifiers

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13-143

Identifier Type: -

Identifier Source: org_study_id