Recruiting

Ultrasound

Sponsor:

Université de Sherbrooke

Code:

NCT02036125

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Ultrasound

methylprednisolone

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT02036125

Start date

Oct, 2013

Status verified date

Dec, 2014

Completion date

Dec, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ultrasound guided injection

Ultrasound guided injection of 40 mg of methylprednisolone

active comparator: Blind injection

Blind injection of 40 mg of methylprednisolone

Interventions

Ultrasound

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

methylprednisolone

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

Primary outcome measure

  • Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Alessandra Bruns, MD, FRCPC

819 564 5261

Locations

Centre Hospitalier Universitaire de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Alessandra Bruns, MD, FRCPC

819 564 5261

Anne-Marie Pitre-Joyal, MD

418 649 0252

More Information

Sponsor

Université de Sherbrooke

Last update posted

Dec 16, 2014

Last verified

Dec, 2014

Keywords

  • Corticosteroid
  • Ultrasound
  • Guided injection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2014-12-16.