NCT02036125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

January 11, 2014

Last Update Submit

December 13, 2014

Conditions

Carpal Tunnel Syndrome

Keywords

CorticosteroidUltrasoundGuided injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale

    3 months

  • DASH questionnaire

    3 months

  • Numeric Pain Rating Scale

    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

  • +3 more secondary outcomes

Other Outcomes (2)

  • Trial group assignment - Patient

    3 months

  • Trial group assignment - Assessor

    3 months

Study Arms (2)

Ultrasound guided injection

EXPERIMENTAL

Ultrasound guided injection of 40 mg of methylprednisolone

Device: UltrasoundDrug: methylprednisolone

Blind injection

ACTIVE COMPARATOR

Blind injection of 40 mg of methylprednisolone

Drug: methylprednisolone

Interventions

UltrasoundDEVICE

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

Ultrasound guided injection
methylprednisoloneDRUG

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

Blind injectionUltrasound guided injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

UltrasonographyMethylprednisolone

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Alessandra Bruns, Md, FRCPC

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Bruns, MD, FRCPC

CONTACT

819 564 5261

Anne-Marie Pitre-Joyal, MD

CONTACT

418 649 0252anne-marie.joyal.2@ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC

Study Record Dates

First Submitted

January 11, 2014

First Posted

January 14, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

CA(1)