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NCT Number: NCT05809622

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

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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Pelin Tiryaki

CONTACT

[email protected]

902124040300

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elbow focused rehabilitation

Behavioral
  • 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

Behavioral
  • 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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Pain Pressure Threshold (PPT)

    Time frame: Baseline

    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.

  2. Pain Pressure Threshold (PPT)

    Time frame: 8th week

    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.

  3. Pain Pressure Threshold (PPT)

    Time frame: 16th week

    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.

  4. Pain Pressure Threshold (PPT)

    Time frame: 6th month

    PPT measurement will be made using an algometer. It will be evaluated with an digital algometer over the lateral epicondyle in both upper extremities.

  5. Hand Grip Strength

    Time frame: Baseline

    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.

  6. Hand Grip Strength

    Time frame: 8th week

    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.

  7. Hand Grip Strength

    Time frame: 16th week

    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.

  8. Hand Grip Strength

    Time frame: 6th month

    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.

  9. Pain-free Hand Grip Strength

    Time frame: Baseline

    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.

  10. Pain-free Hand Grip Strength

    Time frame: 8th week

    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.

  11. Pain-free Hand Grip Strength

    Time frame: 16th week

    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.

  12. Pain-free Hand Grip Strength

    Time frame: 6th month

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 12, 2023
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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