NCT02514317

Brief Summary

The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 23, 2015

Last Update Submit

July 31, 2015

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (3)

  • Pain (visual analogic scale)

    visual analogic scale

    change between baseline and day 90 after surgery

  • paresthesia

    change between baseline and day 90 after surgery

  • muscle strength (dynamometer JAMARD)

    dynamometer JAMARD

    change between baseline and day 90 after surgery

Study Arms (1)

percutaneous treatment

EXPERIMENTAL

percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.

Procedure: percutaneous treatmentDevice: Ultrasound

Interventions

percutaneous treatmentPROCEDURE
percutaneous treatment
UltrasoundDEVICE
percutaneous treatment

Eligibility Criteria

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

You may qualify if:

  • Patient older than 18 years who signed the informed consent.
  • Patient with an Carpal Tunnel Syndrome

You may not qualify if:

  • patient has already undergone surgery of Carpal Tunnel Syndrome
  • Patient with contra-indications to anesthesia (heart failure, kidney, liver).
  • Pregnant women
  • alcoholics in weaning period
  • Patient whose consent is altered or unable to get a safety procedure
  • Patient with contra-indication to lidocaine
  • Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Caen, 14000, France

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography

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 ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 3, 2015

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

FR(1)