NCT04911920

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 21, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4.7 years

First QC Date

May 21, 2021

Last Update Submit

May 31, 2024

Conditions

Keywords

QuestionnairePRTEE

Outcome Measures

Primary Outcomes (1)

  • Questionnaire Patient Rated Tennis Elbow Evaluation

    Participants are asked to complete questionnaires at each of three measurement time points.

    Ten Weeks

Secondary Outcomes (5)

  • Sociodemographic data

    Ten Weeks

  • The Disabilities of Arm Shoulder and Hand (DASH) questionnaire

    Ten Weeks

  • The Patient Rated Elbow Evaluation (PREE)

    Ten Weeks

  • EQ-5D-5L

    Ten Weeks

  • Patient satisfaction Questionnaire

    Ten Weeks

Study Arms (1)

Patients with lateral epicondylitis

OTHER

Patients with lateral epicondylitis who are treated with at least one ACP injection.

Other: Questionnaire Patient Rated Tennis Elbow Evaluation

Interventions

Participants are asked to complete questionnaires at three measurement time points.

Patients with lateral epicondylitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Miriam Marks, PhD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Marks, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

May 21, 2021

First Posted

June 3, 2021

Study Start

August 4, 2021

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations