The Effect of Tendon Tears on Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06206109
• Other study ID #: LEtendontears
• Status: Completed
• Start date: September 13, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 1, 2023
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tendon Tear
• Tennis Elbow

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rated Tennis Elbow Evaluation (PRTEE)	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.	Day 1
Secondary	Maximum tendon thickness measurements (capitellar - radiocapitellar)	Maximum tendon thickness measurements (capitellar - radiocapitellar) were detected with ultrasonography of the lateral epicondyle region of the humerus	Day 1
Secondary	Presence of bone abnormality	The presence of bone abnormality were detected with ultrasonography of the lateral epicondyle region of the humerus	Day 1
Secondary	Visual Analog Scale (VAS)	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.	All patients were evaluated for one time.
Secondary	Hand Grip Strength	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.	Day 1
Secondary	Pain Sensitivity	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.	Day 1