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

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
methylprednisolone
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Corticosteroid, Ultrasound, Guided injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de SherbrookeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound guided injection

Blind injection

Arm Description

Ultrasound guided injection of 40 mg of methylprednisolone

Blind injection of 40 mg of methylprednisolone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2014
Last Updated
December 13, 2014
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT02036125
Brief Title
Carpal Tunnel Syndrome - Randomized Clinical Trial Evaluating Effectiveness of Ultrasound in Corticosteroid Injection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Corticosteroid, Ultrasound, Guided injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided injection
Arm Type
Experimental
Arm Description
Ultrasound guided injection of 40 mg of methylprednisolone
Arm Title
Blind injection
Arm Type
Active Comparator
Arm Description
Blind injection of 40 mg of methylprednisolone
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
Subjects will receive a blind injection of 40 mg of methylprednisolone.
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
Description
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale
Description
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
Time Frame
3 months
Title
DASH questionnaire
Time Frame
3 months
Title
Numeric Pain Rating Scale
Description
Mean pain felt in the last 2 weeks
Time Frame
3 months
Title
Ultrasound measured medial nerve area in carpal tunnel
Time Frame
3 months
Title
Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel
Time Frame
3 months
Title
Ultrasound hypervascularisation of medial nerve in carpal tunnel
Time Frame
3 months
Title
Numeric Pain Rating Scale
Description
Pain during injection
Time Frame
Baseline
Title
Global Rating of Change
Description
The Global Rating of Change scale is meant to quantify the improvement or deterioration perceived by the patient.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Trial group assignment - Patient
Description
Questionnaire to verify patient's beliefs regarding his group allocation at follow-up.
Time Frame
3 months
Title
Trial group assignment - Assessor
Description
Questionnaire to verify assessor's beliefs regarding a patient group allocation at follow-up.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Bruns, MD, FRCPC
Phone
819 564 5261
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Marie Pitre-Joyal, MD
Phone
418 649 0252
Ext
5751
Email
anne-marie.joyal.2@ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Bruns, Md, FRCPC
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Bruns, MD, FRCPC
Phone
819 564 5261
First Name & Middle Initial & Last Name & Degree
Anne-Marie Pitre-Joyal, MD
Phone
418 649 0252
Ext
5751

12. IPD Sharing Statement

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

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