Back to resultsValidation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)
Primary Purpose
Elbow Tendinitis, Elbow, Tennis
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Questionnaire Patient Rated Tennis Elbow Evaluation
Sponsored by
About this trial
This is an interventional other trial for Elbow Tendinitis focused on measuring Questionnaire, PRTEE
Eligibility Criteria
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)
Sites / Locations
- Schulthess KlinikRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with lateral epicondylitis
Arm Description
Patients with lateral epicondylitis who are treated with at least one ACP injection.
Outcomes
Primary Outcome Measures
Questionnaire Patient Rated Tennis Elbow Evaluation
Participants are asked to complete questionnaires at each of three measurement time points.
Secondary Outcome Measures
Sociodemographic data
The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
The patient questionnaire measures impairment of the upper extremity
The Patient Rated Elbow Evaluation (PREE)
It measures the elbow specific pain and limitations
EQ-5D-5L
general measure of health for clinical and economic questions
Patient satisfaction Questionnaire
perceived change regarding their elbow condition
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04911920
Brief Title
Validation of a German Version of the Patient Rated Tennis Elbow Evaluation
Acronym
PRTEE
Official Title
Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miriam Marks
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The German version of the Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire is tested for reliability, validity and responsiveness.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Tendinitis, Elbow, Tennis
Keywords
Questionnaire, PRTEE
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with lateral epicondylitis
Arm Type
Other
Arm Description
Patients with lateral epicondylitis who are treated with at least one ACP injection.
Intervention Type
Other
Intervention Name(s)
Questionnaire Patient Rated Tennis Elbow Evaluation
Intervention Description
Participants are asked to complete questionnaires at three measurement time points.
Primary Outcome Measure Information:
Title
Questionnaire Patient Rated Tennis Elbow Evaluation
Description
Participants are asked to complete questionnaires at each of three measurement time points.
Time Frame
Ten Weeks
Secondary Outcome Measure Information:
Title
Sociodemographic data
Description
The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data
Time Frame
Ten Weeks
Title
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
Description
The patient questionnaire measures impairment of the upper extremity
Time Frame
Ten Weeks
Title
The Patient Rated Elbow Evaluation (PREE)
Description
It measures the elbow specific pain and limitations
Time Frame
Ten Weeks
Title
EQ-5D-5L
Description
general measure of health for clinical and economic questions
Time Frame
Ten Weeks
Title
Patient satisfaction Questionnaire
Description
perceived change regarding their elbow condition
Time Frame
Ten Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Marks, PhD
Phone
+41 44 385 75 81
Email
Miriam.Marks@kws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Marks, PhD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulthess Klinik
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Marks, PhD
Phone
+41 44 385 75 81
Email
miriam.marks@kws.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of a German Version of the Patient Rated Tennis Elbow Evaluation
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