Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04911920
Other study ID # OE-0141
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 4, 2021
Est. completion date April 1, 2024

Study information

Verified date July 2023
Source Schulthess Klinik
Contact Miriam Marks, PhD
Phone +41 44 385 75 81
Email Miriam.Marks@kws.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire Patient Rated Tennis Elbow Evaluation
Participants are asked to complete questionnaires at three measurement time points.

Locations

Country Name City State
Switzerland Schulthess Klinik Zurich

Sponsors (1)

Lead Sponsor Collaborator
Miriam Marks

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire Patient Rated Tennis Elbow Evaluation Participants are asked to complete questionnaires at each of three measurement time points. Ten Weeks
Secondary Sociodemographic data The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data Ten Weeks
Secondary The Disabilities of Arm Shoulder and Hand (DASH) questionnaire The patient questionnaire measures impairment of the upper extremity Ten Weeks
Secondary The Patient Rated Elbow Evaluation (PREE) It measures the elbow specific pain and limitations Ten Weeks
Secondary EQ-5D-5L general measure of health for clinical and economic questions Ten Weeks
Secondary Patient satisfaction Questionnaire perceived change regarding their elbow condition Ten Weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03504111 - PRINT Trial (Platelet Rich Injection vs Needle Tenotomy) N/A
Completed NCT03487250 - Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System