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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Alessandra Bruns, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT02036125
First received: January 11, 2014
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Carpal Tunnel Syndrome
Device: Ultrasound
Drug: methylprednisolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.


Secondary Outcome Measures:
  • Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.

  • DASH questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Numeric Pain Rating Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean pain felt in the last 2 weeks

  • Ultrasound measured medial nerve area in carpal tunnel [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ultrasound hypervascularisation of medial nerve in carpal tunnel [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Numeric Pain Rating Scale [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Pain during injection

  • Global Rating of Change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.


Other Outcome Measures:
  • Trial group assignment - Patient [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire to verify patient's beliefs regarding his group allocation at follow-up.

  • Trial group assignment - Assessor [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Questionnaire to verify assessor's beliefs regarding a patient group allocation at follow-up.


Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036125

Contacts
Contact: Alessandra Bruns, MD, FRCPC 819 564 5261
Contact: Anne-Marie Pitre-Joyal, MD 418 649 0252 ext 5751 anne-marie.joyal.2@ulaval.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Alessandra Bruns, MD, FRCPC    819 564 5261      
Contact: Anne-Marie Pitre-Joyal, MD    418 649 0252 ext 5751      
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Alessandra Bruns, Md, FRCPC Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Alessandra Bruns, MD, FRCPC, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02036125     History of Changes
Other Study ID Numbers: 13-143
Study First Received: January 11, 2014
Last Updated: January 13, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Université de Sherbrooke:
Corticosteroid
Ultrasound
Guided injection

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Disease
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on September 16, 2014