NCT02276105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

October 16, 2014

Last Update Submit

May 20, 2015

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromeQuality of LifeEQ-5DSF-12Michigan Hand Questionnaire

Outcome Measures

Primary Outcomes (1)

  • Quality of life measured with the EQ5D

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

Secondary Outcomes (2)

  • 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)

Interventions

QuestionnairesOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Schulthess Klinik (Zurich, Switzerland) with will be asked to participate on the study.

You may qualify if:

  • age over 18 years
  • diagnosed CTS
  • planned surgical decompression of the carpal tunnel
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 23982906BACKGROUND

  • 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.

    PMID: 17724650BACKGROUND

  • 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.

    PMID: 17534619BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Herren Daniel, Dr. med.

    Schulthess Klinik, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 27, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

CH(1)