NCT07347873

Brief Summary

Lateral elbow tendinopathy (LET) is the most common cause of elbow pain. Even though provocation tests such as Cozen's test, Mill's test or Maudsley test; musculoskeletal ultrasound or magnetic resonance imaging can be used for diagnosis, gold standard method is yet to be determined. Purpose of this study is to determine the sensitivity and specificity of clinical tests and ultrasonography in diagnosis of LET.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 24, 2025

Last Update Submit

January 11, 2026

Conditions

Lateral Elbow Tendinopathy (Tennis Elbow)

Keywords

Elbow painLateral epicondylitisCozenElastography

Outcome Measures

Primary Outcomes (1)

  • Elastography

    Both shear wave and strain elastography will be applied. Stiffness and shear wave velocity will be calculated on shear wave elastography and strain ratio will be calculated on strain elastography.

    At enrollment

Secondary Outcomes (7)

  • Musculoskeletal ultrasound

    At enrollment

  • Cozen's test

    At enrollment

  • Maudsley's Test

    At enrollment

  • Mill's test

    At enrollment

  • Hand Grip Strength

    At enrollment

  • +2 more secondary outcomes

Study Arms (2)

Lateral elbow tendinopathy

Patients with lateral epicondylitis will be included in this group.

Control

Healthy volunteers with similar demographic characteristics will be enrolled to this group.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients presented to the outpatient clinic of Physical Medicine and Rehabilitation of Marmara University with elbow pain and diagnosed with lateral epicondylitis will be informed about the study. Willing patients will be enrolled after written consent is taken. Control group will be chosen with volunteers, which have similar demographic characteristics.

You may qualify if:

  • Patients aged 18-60 with unilateral elbow pain
  • Tenderness with palpation at the lateral epicondyle
  • Pain triggered with pressure compared to the opposite lateral epicondyle with algometer.

You may not qualify if:

  • History of rheumatologic diseases
  • History of e corticosteroid injections on lateral epicondyle
  • History of elbow surgery or infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34844, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Krogh TP, Fredberg U, Ammitzboll C, Ellingsen T. Clinical Value of Ultrasonographic Assessment in Lateral Epicondylitis Versus Asymptomatic Healthy Controls. Am J Sports Med. 2020 Jul;48(8):1873-1883. doi: 10.1177/0363546520921949. Epub 2020 Jun 2.

    PMID: 32484714BACKGROUND

  • Hong S, Hahn S, Yi J, Park EJ, Bang JY. Comparing the clinical application of strain elastography and shear wave elastography for the evaluation of lateral epicondylitis. J Clin Ultrasound. 2023 Jan;51(1):123-130. doi: 10.1002/jcu.23356. Epub 2022 Sep 28.

    PMID: 36169174BACKGROUND

  • Karanasios S, Korakakis V, Moutzouri M, Drakonaki E, Koci K, Pantazopoulou V, Tsepis E, Gioftsos G. Diagnostic accuracy of examination tests for lateral elbow tendinopathy (LET) - A systematic review. J Hand Ther. 2022 Oct-Dec;35(4):541-551. doi: 10.1016/j.jht.2021.02.002. Epub 2021 Feb 27.

    PMID: 33814224BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • İlker Yağcı, Prof. M.D.

    Acıbadem Ataşehir Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arda Can Kasap, M.D.

CONTACT

+902166254545drardakasap@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.D.

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 16, 2026

Study Start

October 17, 2025

Primary Completion

January 31, 2026

Study Completion

March 26, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Due to legal restrictions, all data will be anonymized. Individual participant data won't be shared to third parties.

Locations

TU(1)