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

Completed

• Conditions: Carpal Tunnel Syndrome

• Registration Number: NCT02276105
• Lead Sponsor: Schulthess Klinik

Brief Summary

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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life measured with the EQ5D	from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland