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

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ClinicalTrials.gov Identifier: NCT02276105
Recruitment Status : Completed
First Posted : October 27, 2014
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Schulthess Klinik

Study Description
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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.

Condition or disease Intervention/treatment
Carpal Tunnel Syndrome Other: Questionnaires

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Psychometric Properties of the EuroQoL EQ-5D-5L in Patients With Carpal Tunnel Syndrome
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Groups and Cohorts
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Intervention Details:
  • Other: 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

Outcome Measures
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Primary Outcome Measures :
  1. Quality of life measured with the EQ5D [ Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up) ]

Secondary Outcome Measures :
  1. Quality of life measured with the SF 12 [ Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up) ]
  2. Hand function measured with the MHQ [ Time Frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the Schulthess Klinik (Zurich, Switzerland) with will be asked to participate on the study.
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276105


Locations
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Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Investigators
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Principal Investigator: Herren Daniel, Dr. med. Schulthess Klinik, Zurich, Switzerland
More Information
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Publications:

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Responsible Party: Schulthess Klinik
ClinicalTrials.gov Identifier: NCT02276105    
Other Study ID Numbers: Eq5d_val_cts
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Schulthess Klinik:
Carpal Tunnel Syndrome
Quality of Life
EQ-5D
SF-12
Michigan Hand Questionnaire
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries