Lateral EpicondylitisNCT05809622
Upper Extremity-based Exercises and Elbow-focused Exercises in LET
A study testing Elbow focused rehabilitation and Scapular and rotator cuff muscles strengthening in people with Lateral Epicondylitis and Elbow Tendinopathy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Elbow Tendinopathy
- What is being tested?
- Elbow focused rehabilitation and Scapular and rotator cuff muscles strengthening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Cases are between the ages of 18-65
- Getting a diagnosis of unilateral lateral elbow tendinopathy
- At least two positive Thomsen, Maudsley's Mill's and Cozen tests on clinical examination
- Continuing symptoms for at least 3 months
- The absence of any chronic disease that would prevent participation in the treatment program
Who cannot join
- History of trauma or surgery in the involved elbow joint
- Having orthopedic problems in the cervical spine, shoulder joint or wrist
- To have participated in the rehabilitation program in the last 3 months
- Corticosteroid injection application in the last 3 months
- Systemic arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpaşa
Istanbul
Pelin Tiryaki, 902124040300, ptpelintiryaki@gmail.com
About this study
Official title: Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow TendiNopathy
The aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program.
- Conditions
- Lateral Epicondylitis, Elbow Tendinopathy
- Being tested
- Elbow focused rehabilitation, Scapular and rotator cuff muscles strengthening
- Keywords
- tendinopathy, elbow
- Medical subject headings
- Tennis Elbow, Elbow Tendinopathy, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow focused rehabilitationBehavioural
- Patient education
- Activity modification
- 2 days/week, 8 weeks in total
- Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening)
Scapular and rotator cuff muscles strengtheningBehavioural
- Patient education
- Activity modification
- 2 days/week, 8 weeks in total
- Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening)
- Scapular stabilizer muscle + rotator cuff (RM) strengthening
| Study group | Role | What they receive |
|---|---|---|
| Shoulder and scapular strengthening group | Experimental | Not described Receives: Behavioral: Scapular and rotator cuff muscles strengthening |
| Control group | Active comparator | Not described Receives: Behavioral: Elbow focused rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Measured: Baseline
Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Measured: 8th week
Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Measured: 16th week
Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Measured: 6th month
Numeric Pain Rating Scale (NPRS)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Measured: Baseline
Numeric Pain Rating Scale (NPRS)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Measured: 8th week
Numeric Pain Rating Scale (NPRS)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Measured: 16th week
Numeric Pain Rating Scale (NPRS)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Measured: 6th month
Secondary outcomes (12)
Pain Pressure Threshold (PPT)
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
Measured: Baseline
Pain Pressure Threshold (PPT)
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
Measured: 8th week
Pain Pressure Threshold (PPT)
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
Measured: 16th week
Pain Pressure Threshold (PPT)
PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.
Measured: 6th month
Hand Grip Strength
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: Baseline
Hand Grip Strength
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 8th week
Hand Grip Strength
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 16th week
Hand Grip Strength
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength. To assess grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 6th month
Pain-free Hand Grip Strength
Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: Baseline
Pain-free Hand Grip Strength
Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 8th week
Pain-free Hand Grip Strength
Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 16th week
Pain-free Hand Grip Strength
Pain-free grip strength is an important outcome measure in lateral elbow tendinopathy (LET). To assess pain-free grip strength, the Jamar dynamometer will be used which is recommended by the American Society for Surgery of the Hand and the American Society of Hand Therapists.
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start10 Apr 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Tiryaki, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809622
- Sponsor's protocol ID
- 2022-05
- Status last verified
- Nov 2024
- First submitted
- 6 Jun 2022
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow TendiNopathy
- ClinicalTrials.gov ID
- NCT05809622
- Acronym / sponsor ID
- 2022-05
- Conditions
- Lateral Epicondylitis, Elbow Tendinopathy
- Keywords
- tendinopathy, elbow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 12 Apr 2023 (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 aim of the study is to investigate the effects of rotator cuff and scapular muscle strengthening exercises applied in addition to the 8-week elbow focused rehabilitation program in lateral elbow tendinopathy, by comparing it with the elbow focused rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder and scapular strengthening group | Experimental | Behavioral: Scapular and rotator cuff muscles strengthening |
| Control group | Active comparator | Behavioral: Elbow focused rehabilitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cases are between the ages of 18-65
- Getting a diagnosis of unilateral lateral elbow tendinopathy
- At least two positive Thomsen, Maudsley's Mill's and Cozen tests on clinical examination
- Continuing symptoms for at least 3 months
- The absence of any chronic disease that would prevent participation in the treatment program
Key exclusion criteria (5 listed)
- History of trauma or surgery in the involved elbow joint
- Having orthopedic problems in the cervical spine, shoulder joint or wrist
- To have participated in the rehabilitation program in the last 3 months
- Corticosteroid injection application in the last 3 months
- Systemic arthritis
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 |
|---|---|---|
| Elbow focused rehabilitation* Patient education * Activity modification * 2 days/week, 8 weeks in total * Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening) | Behavioural | Control group |
| Scapular and rotator cuff muscles strengthening* Patient education * Activity modification * 2 days/week, 8 weeks in total * Exercises for the wrist extensor tendon, especially the extensor carpi radialis brevis (EKRB) (stretching + strengthening) * Scapular stabilizer muscle + rotator cuff (RM) strengthening | Behavioural | Shoulder and scapular strengthening group |
Primary outcome
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 8th week
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 16th week
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 6th month
The Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE) is a specific questionnaire available for assessing the health status of patients with lateral epicondylitis.
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Numeric Pain Rating Scale (NPRS)
Time frame: 8th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Numeric Pain Rating Scale (NPRS)
Time frame: 16th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Numeric Pain Rating Scale (NPRS)
Time frame: 6th month
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
12 secondary outcomes
Pain Pressure Threshold (PPT)
Time frame: Baseline
Pain Pressure Threshold (PPT)
Time frame: 8th week
Pain Pressure Threshold (PPT)
Time frame: 16th week
Pain Pressure Threshold (PPT)
Time frame: 6th month
Hand Grip Strength
Time frame: Baseline
Hand Grip Strength
Time frame: 8th week
Hand Grip Strength
Time frame: 16th week
Hand Grip Strength
Time frame: 6th month
Pain-free Hand Grip Strength
Time frame: Baseline
Pain-free Hand Grip Strength
Time frame: 8th week
Pain-free Hand Grip Strength
Time frame: 16th week
Pain-free Hand Grip Strength
Time frame: 6th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow focused rehabilitation and Scapular and rotator cuff muscles strengthening in people with Lateral Epicondylitis and Elbow Tendinopathy, run by Istanbul University - Cerrahpasa 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Tennis Elbow Evaluation (PRTEE) (time frame: Baseline). The study lists 8 primary outcomes in all. 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 8 Nov 2024.