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NCT Number: NCT06206109

The Effect of Tendon Tears on Lateral Epicondylitis

Common extensor tendon (CET) tears that can be detected with ultrasonography (US) may be associated with worsening clinical and other ultrasonographic parameters in patients with LE. In this retrospective evaluation of patients with lateral epicondylitis (LE), the effect of common extensor tendon (CET) tears revealed by ultrasonography (US) with demographic, clinical, and other US findings was investigated.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

About this study

The files of 227 patients with LE who applied to Dokuz Eylül University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Clinic and met the inclusion and exclusion criteria were reviewed retrospectively.

The demographic characteristics of the patients were recorded.

First of all, common extensor tendon tears, if it existed, were demonstrated with ultrasonography. Then, primary and secondary outcome measures were performed.

Maximum tendon thickness measurements (capitellar - radiocapitellar) and the presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus.

The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at night (VAS-night), and during ADL (VAS-ADL).

Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®) to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt pain and the average value in kg/cm2 (repeated three times) were recorded.

PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used

The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position between supination and pronation. The average value in kilogram-force (repeated three times). Between repeated measures 1-minute resting, periods were given.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 18-65 years
  • diagnosis of LE based on clinical parameters and US findings
  • duration of symptoms ranging from 2 to 12 weeks
  • agreement to participate in the study

Exclusion criteria

  • LE findings in the other extremity
  • has received any treatment for lateral epicondylitis before
  • previous elbow surgery
  • history of elbow fracture
  • upper extremity muscle weakness due to radiculopathy or neuropathy
  • the presence of concurrent neurological, rheumatic, psychiatric, or malignant conditions
  • pregnancy
  • inability to comply with the study requirements

Treatment and study plan

Primary outcomes

  1. Patient Rated Tennis Elbow Evaluation (PRTEE)

    Time frame: Day 1

    PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and functional deficiencies. The Turkish version of the PRTEE questionnaire was used. PRTEE total score will be evaluated between 0-100. A higher score is associated with worse clinical outcome and function.

Secondary outcomes

  1. Maximum tendon thickness measurements (capitellar - radiocapitellar)

    Time frame: Day 1

    Maximum tendon thickness measurements (capitellar - radiocapitellar) were detected with ultrasonography of the lateral epicondyle region of the humerus

  2. Presence of bone abnormality

    Time frame: Day 1

    The presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus

  3. Visual Analog Scale (VAS)

    Time frame: All patients were evaluated for one time.

    The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at night (VAS-night), and during ADL (VAS-ADL). The VAS score will be evaluated between 0-10. A higher score is consistent with more severe pain.

  4. Hand Grip Strength

    Time frame: Day 1

    The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position between supination and pronation. The average value in kilogram-force (repeated three times). Between repeated measures 1-minute resting, periods were given.

  5. Pain Sensitivity

    Time frame: Day 1

    Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®) to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt pain and the average value in kg/cm2 (repeated three times) were recorded.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Is There a Relationship Between The Common Extensor Tendon Tears and Clinical-Ultrasonographic Changes in Lateral Epicondylitis?

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2024
Registry last updated
Jan 18, 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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