Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)

July 17, 2023 updated by: Miriam Marks

Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)

The German version of the Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire is tested for reliability, validity and responsiveness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this prospective study, patients with lateral epicondylitis will complete the PRTEE before ACP injection, 6 weeks after treatment and 2-11 days later.

The statistics will include analyses about reliability, validity and responsiveness.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Recruiting
        • Schulthess Klinik
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosed lateral epicondylitis
  • Receive a first ACP treatment at the Schulthess Klinik
  • Signed informed consent form

Exclusion Criteria:

  • Lack of German language skills, which make it impossible to complete the questionnaire
  • Diseases or conditions that would prevent accurate evaluation (e.g. central neurological, psychiatric or metabolic diseases)
  • Legal incompetence
  • Recent operations on the elbow or hand (less than three months ago)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with lateral epicondylitis
Patients with lateral epicondylitis who are treated with at least one ACP injection.
Other: Questionnaire Patient Rated Tennis Elbow Evaluation
Participants are asked to complete questionnaires at three measurement time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire Patient Rated Tennis Elbow Evaluation
Time Frame: Ten Weeks
Participants are asked to complete questionnaires at each of three measurement time points.
Ten Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data
Time Frame: Ten Weeks
The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data
Ten Weeks
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
Time Frame: Ten Weeks
The patient questionnaire measures impairment of the upper extremity
Ten Weeks
The Patient Rated Elbow Evaluation (PREE)
Time Frame: Ten Weeks
It measures the elbow specific pain and limitations
Ten Weeks
EQ-5D-5L
Time Frame: Ten Weeks
general measure of health for clinical and economic questions
Ten Weeks
Patient satisfaction Questionnaire
Time Frame: Ten Weeks
perceived change regarding their elbow condition
Ten Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miriam Marks

Investigators

  • Principal Investigator: Miriam Marks, PhD, Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OE-0141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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