Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome

May 20, 2015 updated by: Schulthess Klinik
The purpose of this study is to determine how appropriate and practically is the EQ-5D questionnaire in use on patients with carpal tunnel syndrome undergoing surgery along the change of quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carpal Tunnel Syndrome (CTS) is one of the most indications in hand surgery. To rate surgery's outcome, hand-specific instruments like the Michigan Hand Questionnaire (MHQ) are used as well as questionnaires which refers to the quality of life (QOL). In clinical daily grind, the SF-12 or the EQ-5D are common instruments to gain information about the patient's QOL. At the time, there is no current evidence available while using standardized questionnaires like the EQ-5D to capture the change in QOL in patients with CTS undergoing surgery. It would be interesting to assert that the investigation offers results about the patient's QOL and its change. Therefore, the aim of the study is to investigate the psychometric properties of the EQ-5D on patients with CTS undergoing surgery.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the Schulthess Klinik (Zurich, Switzerland) with will be asked to participate on the study.

Description

Inclusion Criteria:

  • age over 18 years
  • diagnosed CTS
  • planned surgical decompression of the carpal tunnel
  • signed informed consent

Exclusion Criteria:

  • additional simultaneously performed hand surgery of the affected limb
  • recurrent surgery on the already involved hand
  • the other hand is already included in the study
  • disease, which do not allow appropriated analysis of data like central-neurological, psychiatric or metabolic disease
  • legal incompetence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured with the EQ5D
Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life measured with the SF 12
Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
Hand function measured with the MHQ
Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Investigators

  • Principal Investigator: Herren Daniel, Dr. med., Schulthess Klinik, Zurich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eq5d_val_cts

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe