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

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.

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis; Elbow Tendinopathy
• Intervention / Treatment: Behavioral: Scapular and rotator cuff muscles strengthening; Behavioral: Elbow focused rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Istanbul University Cerrahpasa
    • Contact: Pelin Tiryaki; Phone Number: 902124040300; Email: ptpelintiryaki@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	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)
Experimental: Shoulder and scapular strengthening group	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: tendinopathy; elbow
• Additional Relevant MeSH Terms: Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Elbow Tendinopathy; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 2022-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No