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

Lateral Epicondylitis Clinical Trial

Official title:

Comparison of the Effectiveness of Upper Extremity-based Exercises and Elbow-focused Exercises in Lateral Elbow tendiNopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05809622
• Other study ID #: 2022-05
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Elbow Tendinopathy
• Lateral Epicondylitis
• Tendinopathy
• Tennis Elbow

Intervention

Behavioral:
• 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)
• 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

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	8th week
Primary	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.	16th week
Primary	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.	6th month
Primary	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.	Baseline
Primary	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.	8th week
Primary	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.	16th week
Primary	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.	6th month
Secondary	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.	Baseline
Secondary	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.	8th week
Secondary	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.	16th week
Secondary	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.	6th month
Secondary	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.	Baseline
Secondary	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.	8th week
Secondary	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.	16th week
Secondary	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.	6th month
Secondary	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.	Baseline
Secondary	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.	8th week
Secondary	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.	16th week
Secondary	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.	6th month