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Completed

NCT Number: NCT02276105

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Quality of life measured with the EQ5D

    Time frame: from two weeks before surgery (Baseline) to six weeks postoperative (Follow-Up)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2014
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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