NCT07314840

Brief Summary

Lateral epicondylitis (LE) is the tendinopathy of the common extensor tendon. Although exact etiology remains unclear, it is believed to be caused by overuse. Even though, genetics factor related to tendinopathies were defined accompanying tendinopathies in patients with LE is yet to be studied. Madrid sonographic enthesitis index (MASEI) is an ultrasound based scoring system, developed for the evaluation of the enthesitis. Initially developed for ankylosing spondylitis, its usage has also become widespread in other musculoskeletal diseases. The aim of this study is to calculate the MASEI score in patients diagnosed with LE, and compare it to healthy volunteers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 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 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Lateral EpicondylitisLateral Elbow TendinopathyTennis ElbowEnthesitisMadrid Sonographic Enthesitis IndexMASEI

Outcome Measures

Primary Outcomes (1)

  • Madrid Sonographic Enthesitis Index

    Patients will be evaluated with ultrasound at 6 different locations on each side, for total of 12 locations. At each location; structure and thickness of the tendon, the presence of calcifications or enthesophytes, erosions in the bone, regional bursitis, and the presence of power-Doppler signal will be noted. Each parameter has a point of its own. Points obtained from each parameter will be added and total MASEI score (0-136) will be calculated. Higher scores indicate the presence of enthesitis.

    At enrollment

Study Arms (2)

Lateral Epicondylitis

Patients with lateral epicondylitis will be included in this group.

Diagnostic Test: Madrid Sonographic Enthesitis Index

Control

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

Diagnostic Test: Madrid Sonographic Enthesitis Index

Interventions

Patients will be evaluated with ultrasound at 6 different locations on each side, for total of 12 locations. These will be insertion points of triceps brachii tendon, quadriceps tendon, proximal and distal patellar tendons, achilles tendon and the plantar fascia. Evaluation parameters are the structure and thickness of the tendon, the presence of calcifications or enthesophytes, erosions in the bone, regional bursitis, and the presence of power-Doppler signal in the entheses.

Also known as: MASEI
ControlLateral Epicondylitis

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:

  • Tenderness with palpation at the lateral epicondyle
  • Pain aggravated with resisted wrist extension

You may not qualify if:

  • History of rheumatologic diseases
  • History of elbow, knee or ankle surgery
  • History of corticosteroid injections on elbow, knee or ankle
  • History of peripheral neuropathy
  • Acute trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34844, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Ozsoy-Unubol T, Yagci I. Is ultrasonographic enthesitis evaluation helpful for diagnosis of non-radiographic axial spondyloarthritis? Rheumatol Int. 2018 Nov;38(11):2053-2061. doi: 10.1007/s00296-018-4164-4. Epub 2018 Oct 9.

    PMID: 30302556BACKGROUND
  • de Miguel E, Cobo T, Munoz-Fernandez S, Naredo E, Uson J, Acebes JC, Andreu JL, Martin-Mola E. Validity of enthesis ultrasound assessment in spondyloarthropathy. Ann Rheum Dis. 2009 Feb;68(2):169-74. doi: 10.1136/ard.2007.084251. Epub 2008 Apr 7.

    PMID: 18390909BACKGROUND
  • Okur SC, Dogan YP, Mert M, Aksu O, Burnaz O, Caglar NS. Ultrasonographic Evaluation of Lower Extremity Entheseal Sites in Diabetic Patients Using Glasgow Ultrasound Enthesitis Scoring System Score. J Med Ultrasound. 2017 Jul-Sep;25(3):150-156. doi: 10.1016/j.jmu.2017.03.011. Epub 2017 May 6.

    PMID: 30065480BACKGROUND
  • Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.

    PMID: 33123709BACKGROUND
  • 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. Dr.

    Acıbadem Ataşehir Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arda Can Kasap, MD

CONTACT

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 18, 2025

First Posted

January 2, 2026

Study Start

October 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

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