Clinical trial NCT02276105: Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome
Official title: Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Quality of Life
EQ-5D
SF-12
Michigan Hand Questionnaire
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Schulthess Klinik (Zurich, Switzerland) with will be asked to participate on the study.

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.

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

Primary outcomes:
measure: Quality of life measured with the EQ5D
timeFrame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
Secondary outcomes:
measure: Quality of life measured with the SF 12
timeFrame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
measure: Hand function measured with the MHQ
timeFrame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik, Zurich, Switzerland
name: Herren Daniel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.