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

NCT ID: NCT02276105

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaires

On three time-points (Baseline, Retest, Follow-Up), each participant has to fill out the questionnaires: Michigan Hand Questionnaire, EuroQol EQ-5D-5L and the Short Form SF-12 Health Survey

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herren Daniel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik, Zurich, Switzerland

Locations

Schulthess Klinik

Zurich, , Switzerland

Countries

Switzerland

References

Marks M, Audige L, Herren DB, Schindele S, Nelissen RG, Vliet Vlieland TP. Measurement properties of the German Michigan Hand Outcomes Questionnaire in patients with trapeziometacarpal osteoarthritis. Arthritis Care Res (Hoboken). 2014 Feb;66(2):245-52. doi: 10.1002/acr.22124.

Reference Type: BACKGROUND

PMID: 23982906 (View on PubMed)

Assmus H, Antoniadis G, Bischoff C, Haussmann P, Martini AK, Mascharka Z, Scheglmann K, Schwerdtfeger K, Selbmann HK, Towfigh H, Vogt T, Wessels KD, Wustner-Hofmann M. [Diagnosis and therapy of carpal tunnel syndrome--guideline of the German Societies of Handsurgery, Neurosurgery, Neurology, Orthopaedics, Clinical Neurophysiology and Functional Imaging, Plastic, Reconstructive and Aesthetic Surgery, and Surgery for Traumatology]. Handchir Mikrochir Plast Chir. 2007 Aug;39(4):276-88. doi: 10.1055/s-2007-965464. German.

Reference Type: BACKGROUND

PMID: 17724650 (View on PubMed)

Changulani M, Okonkwo U, Keswani T, Kalairajah Y. Outcome evaluation measures for wrist and hand: which one to choose? Int Orthop. 2008 Feb;32(1):1-6. doi: 10.1007/s00264-007-0368-z. Epub 2007 May 30.

Reference Type: BACKGROUND

PMID: 17534619 (View on PubMed)

Other Identifiers

Eq5d_val_cts

Identifier Type: -

Identifier Source: org_study_id