Elbow TendinitisPRTEENCT04911920
Validation of a German Version of the Patient Rated Tennis Elbow Evaluation
A study testing Questionnaire Patient Rated Tennis Elbow Evaluation in people with Elbow Tendinitis and Elbow, Tennis, run by Miriam Marks at 1 site in Switzerland.
Trial summary
The German version of the Patient Rated Tennis Elbow Evaluation (PRTEE) questionnaire is tested for reliability, validity and responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Tendinitis, Elbow, Tennis
- What is being tested?
- Questionnaire Patient Rated Tennis Elbow Evaluation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Aug 2021to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Diagnosed lateral epicondylitis
- Receive a first ACP treatment at the Schulthess Klinik
- Signed informed consent form
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Schulthess Klinik
Zurich, 8008
Miriam Marks, PhD, +41 44 385 75 81, miriam.marks@kws.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Elbow Tendinitis, Elbow, Tennis
- Being tested
- Questionnaire Patient Rated Tennis Elbow Evaluation
- Keywords
- Questionnaire, PRTEE
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire Patient Rated Tennis Elbow EvaluationOther
Participants are asked to complete questionnaires at three measurement time points.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lateral epicondylitis | Other | Patients with lateral epicondylitis who are treated with at least one ACP injection. Receives: Other: Questionnaire Patient Rated Tennis Elbow Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Patient Rated Tennis Elbow Evaluation
Participants are asked to complete questionnaires at each of three measurement time points.
Measured: Ten Weeks
Secondary outcomes (5)
Sociodemographic data
The socio-demographic data includes the patient's age, sex, duration of symptoms, handedness and disease-related data
Measured: Ten Weeks
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
The patient questionnaire measures impairment of the upper extremity
Measured: Ten Weeks
The Patient Rated Elbow Evaluation (PREE)
It measures the elbow specific pain and limitations
Measured: Ten Weeks
EQ-5D-5L
general measure of health for clinical and economic questions
Measured: Ten Weeks
Patient satisfaction Questionnaire
perceived change regarding their elbow condition
Measured: Ten Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start4 Aug 2021
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miriam Marks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miriam Marks, Schulthess Klinik
- Investigators
- Miriam Marks, PhD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911920
- Sponsor's protocol ID
- OE-0141
- Acronym
- PRTEE
- Status last verified
- May 2024
- First submitted
- 21 May 2021
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a German Version of the Patient Rated Tennis Elbow Evaluation (PRTEE)
- ClinicalTrials.gov ID
- NCT04911920
- Acronym / sponsor ID
- PRTEE / OE-0141
- Conditions
- Elbow Tendinitis, Elbow, Tennis
- Keywords
- Questionnaire, PRTEE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Miriam MarksUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lateral epicondylitis | Other | Other: Questionnaire Patient Rated Tennis Elbow EvaluationPatients with lateral epicondylitis who are treated with at least one ACP injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Diagnosed lateral epicondylitis
- Receive a first ACP treatment at the Schulthess Klinik
- Signed informed consent form
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire Patient Rated Tennis Elbow EvaluationParticipants are asked to complete questionnaires at three measurement time points. | Other | Patients with lateral epicondylitis |
Primary outcome
Questionnaire Patient Rated Tennis Elbow Evaluation
Time frame: Ten Weeks
Participants are asked to complete questionnaires at each of three measurement time points.
5 secondary outcomes
Sociodemographic data
Time frame: Ten Weeks
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire
Time frame: Ten Weeks
The Patient Rated Elbow Evaluation (PREE)
Time frame: Ten Weeks
EQ-5D-5L
Time frame: Ten Weeks
Patient satisfaction Questionnaire
Time frame: Ten Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Elbow Tendinitis
RecruitingObservational study
Embo Registry; National Registry for Artery Embolization
Chronic Pain, Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Marks, PhD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire Patient Rated Tennis Elbow Evaluation in people with Elbow Tendinitis and Elbow, Tennis, run by Miriam Marks at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Marks, PhD (+41 44 385 75 81, Miriam.Marks@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Patient Rated Tennis Elbow Evaluation (time frame: Ten Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.