Lateral EpicondylitisNCT06206109
The Effect of Tendon Tears on Lateral Epicondylitis
An observational study of Lateral Epicondylitis and Tennis Elbow, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Common extensor tendon (CET) tears that can be detected with ultrasonography (US) may be associated with worsening clinical and other ultrasonographic parameters in patients with LE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow, Tendon Tear
- How many people
- 227 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2023to 1 Nov 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The files of 227 patients with LE who met the inclusion and exclusion criteria were reviewed retrospectively.
Who may be able to join
- age between 18-65 years
- diagnosis of LE based on clinical parameters and US findings
- duration of symptoms ranging from 2 to 12 weeks
- agreement to participate in the study
Who cannot join
- LE findings in the other extremity
- has received any treatment for lateral epicondylitis before
- previous elbow surgery
- history of elbow fracture
- upper extremity muscle weakness due to radiculopathy or neuropathy
- the presence of concurrent neurological, rheumatic, psychiatric, or malignant conditions
- pregnancy
- inability to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There a Relationship Between The Common Extensor Tendon Tears and Clinical-Ultrasonographic Changes in Lateral Epicondylitis?
Common extensor tendon (CET) tears that can be detected with ultrasonography (US) may be associated with worsening clinical and other ultrasonographic parameters in patients with LE. In this retrospective evaluation of patients with lateral epicondylitis (LE), the effect of common extensor tendon (CET) tears revealed by ultrasonography (US) with demographic, clinical, and other US findings was investigated.
Read the detailed description
The files of 227 patients with LE who applied to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic and met the inclusion and exclusion criteria were reviewed retrospectively.
The demographic characteristics of the patients were recorded.
First of all, common extensor tendon tears, if it existed, were demonstrated with ultrasonography. Then, primary and secondary outcome measures were performed.
Maximum tendon thickness measurements (capitellar - radiocapitellar) and the presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus.
The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at night (VAS-night), and during ADL (VAS-ADL).
Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®) to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt pain and the average value in kg/cm2 (repeated three times) were recorded.
PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used
The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position between supination and pronation. The average value in kilogram-force (repeated three times). Between repeated measures 1-minute resting, periods were given.
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendon Tear
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Extensor Tendon, Tendon Tear, Ultrasonography
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with common extensor tendon tears | the participants who have common extensor tendon tears demonstrated with ultrasonography. | |
| without common extensor tendon tears | the participants who do not have common extensor tendon tears demonstrated with ultrasonography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Tennis Elbow Evaluation (PRTEE)
PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used. PRTEE total score will be evaluated between 0-100. A higher score is associated with worse clinical outcome and function.
Measured: Day 1
Secondary outcomes (5)
Maximum tendon thickness measurements (capitellar - radiocapitellar)
Maximum tendon thickness measurements (capitellar - radiocapitellar) were detected with ultrasonography of the lateral epicondyle region of the humerus
Measured: Day 1
Presence of bone abnormality
The presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus
Measured: Day 1
Visual Analog Scale (VAS)
The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at night (VAS-night), and during ADL (VAS-ADL). The VAS score will be evaluated between 0-10. A higher score is consistent with more severe pain.
Measured: All patients were evaluated for one time.
Hand Grip Strength
The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position between supination and pronation. The average value in kilogram-force (repeated three times). Between repeated measures 1-minute resting, periods were given.
Measured: Day 1
Pain Sensitivity
Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®) to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt pain and the average value in kg/cm2 (repeated three times) were recorded.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start13 Sep 2023
- Primary completion25 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
- Investigators
- Banu Dilek, Assoc Prof, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206109
- Sponsor's protocol ID
- LEtendontears
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between The Common Extensor Tendon Tears and Clinical-Ultrasonographic Changes in Lateral Epicondylitis?
- ClinicalTrials.gov ID
- NCT06206109
- Acronym / sponsor ID
- LEtendontears
- Conditions
- Lateral Epicondylitis, Tennis Elbow, Tendon Tear
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Extensor Tendon, Tendon Tear, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 16 Jan 2024 (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.
Common extensor tendon (CET) tears that can be detected with ultrasonography (US) may be associated with worsening clinical and other ultrasonographic parameters in patients with LE. In this retrospective evaluation of patients with lateral epicondylitis (LE), the effect of common extensor tendon (CET) tears revealed by ultrasonography (US) with demographic, clinical, and other US findings was investigated.
Detailed description
The files of 227 patients with LE who applied to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic and met the inclusion and exclusion criteria were reviewed retrospectively.
The demographic characteristics of the patients were recorded.
First of all, common extensor tendon tears, if it existed, were demonstrated with ultrasonography. Then, primary and secondary outcome measures were performed.
Maximum tendon thickness measurements (capitellar - radiocapitellar) and the presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus.
The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at night (VAS-night), and during ADL (VAS-ADL).
Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®) to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt pain and the average value in kg/cm2 (repeated three times) were recorded.
PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used
The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position between supination and pronation. The average value in kilogram-force (repeated three times). Between repeated measures 1-minute resting, periods were given.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with common extensor tendon tears | – | –the participants who have common extensor tendon tears demonstrated with ultrasonography. |
| without common extensor tendon tears | – | –the participants who do not have common extensor tendon tears demonstrated with ultrasonography. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The files of 227 patients with LE who met the inclusion and exclusion criteria were reviewed retrospectively.
Key inclusion criteria (4 listed)
- age between 18-65 years
- diagnosis of LE based on clinical parameters and US findings
- duration of symptoms ranging from 2 to 12 weeks
- agreement to participate in the study
Key exclusion criteria (8 listed)
- LE findings in the other extremity
- has received any treatment for lateral epicondylitis before
- previous elbow surgery
- history of elbow fracture
- upper extremity muscle weakness due to radiculopathy or neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Day 1
PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used. PRTEE total score will be evaluated between 0-100. A higher score is associated with worse clinical outcome and function.
5 secondary outcomes
Maximum tendon thickness measurements (capitellar - radiocapitellar)
Time frame: Day 1
Presence of bone abnormality
Time frame: Day 1
Visual Analog Scale (VAS)
Time frame: All patients were evaluated for one time.
Hand Grip Strength
Time frame: Day 1
Pain Sensitivity
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
Banu Dilek, Assoc Prof study chair
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis and Tennis Elbow, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 8 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: finished, as of the sponsor's last update on 18 Jan 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: Day 1). 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 18 Jan 2024.