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RecruitingNCT05809622Updated Nov 8, 2024

Upper Extremity-based Exercises and Elbow-focused Exercises in LET

An interventional study of Elbow focused rehabilitation and Scapular and rotator cuff muscles strengthening in Lateral Epicondylitis and Elbow Tendinopathy, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lateral Epicondylitis
  • Elbow Tendinopathy

Keywords

  • tendinopathy
  • elbow
03

In context

Tennis Elbow

296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.

This study's planned enrollment of 46 is close to the median of 50 across 262 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • injection application in the last 3 months
  • Systemic arthritis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Shoulder and scapular strengthening group

    Behavioral: Scapular and rotator cuff muscles strengthening

  • Active comparator
    Control group

    Behavioral: Elbow focused rehabilitation

Interventions

  • BehavioralElbow 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)

  • BehavioralScapular 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 8th week

  3. 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.

    Time frame: 16th week

  4. 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.

    Time frame: 6th month

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: 8th week

  7. 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.

    Time frame: 16th week

  8. 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.

    Time frame: 6th month

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 8th week

  3. 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.

    Time frame: 16th week

  4. 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.

    Time frame: 6th month

  5. 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.

    Time frame: Baseline

  6. 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.

    Time frame: 8th week

  7. 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.

    Time frame: 16th week

  8. 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.

    Time frame: 6th month

  9. 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.

    Time frame: Baseline

  10. 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.

    Time frame: 8th week

  11. 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.

    Time frame: 16th week

  12. 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.

    Time frame: 6th month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Dec 2024, 20 months after the start.

Of 152 non-industry interventional studies with no phase under Tennis Elbow, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 20 months is above that.

Counting every sponsor, half of 154 studies reached it within 8 months; a quarter within 5 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2022
First posted
Apr 12, 2023
StartActual
Apr 10, 2023
Primary completionEst.
Dec 30, 2024
CompletionEst.
Jun 1, 2025
Last update
Nov 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05809622
Responsible party
Pelin Tiryaki (Physical Therapist, MSc, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Apr 12, 2023
Start date
Apr 10, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Nov 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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