NCT06206109

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

January 4, 2024

Last Update Submit

January 17, 2024

Conditions

Keywords

Lateral EpicondylitisTennis ElbowExtensor TendonTendon TearUltrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Maximum tendon thickness measurements (capitellar - radiocapitellar)

    Day 1

  • Presence of bone abnormality

    Day 1

  • Visual Analog Scale (VAS)

    All patients were evaluated for one time.

  • Hand Grip Strength

    Day 1

  • Pain Sensitivity

    Day 1

Study Arms (2)

with common extensor tendon tears

the participants who have common extensor tendon tears demonstrated with ultrasonography.

without common extensor tendon tears

the participants who do not have common extensor tendon tears demonstrated with ultrasonography.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The files of 227 patients with LE who met the inclusion and exclusion criteria were reviewed retrospectively.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Banu Dilek, Assoc Prof

    Dokuz Eylul University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

September 13, 2023

Primary Completion

October 25, 2023

Study Completion

November 1, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations