Central Sensitization and Ultrasound in Lateral Epicondylitis

NCT07827898 | Recruiting

• 1 other identifier: 34/2026
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (LE) is a common musculoskeletal disorder characterized by pain and tenderness over the lateral elbow and may become chronic despite conservative treatment. Although LE is primarily associated with local tendon pathology, central sensitization, radial nerve involvement, and psychosocial factors may contribute to persistent pain and disability. This cross-sectional case-control study aims primarily to compare remote pressure pain thresholds between individuals with chronic LE and healthy controls. Secondary objectives are to compare clinical, functional, psychosocial, and ultrasonographic findings between the groups and to investigate the factors associated with functional impairment in individuals with chronic LE.

Conditions

Central Sensitization; Lateral Epicondylitis

Keywords

lateral epicondylitis; central sensitization; radial nerve

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold (PPT)

  The pressure pain threshold is defined as the lowest pressure level that causes pain. The measurement will be taken from the anterior-medial region of the tibia (a distant, painless, and irrelevant area) using a Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb). The measurement will be applied twice at 1-minute intervals, and the average of these applications will be recorded. A trial test will be conducted on the patient before the actual test. Pressure will be applied to the selected points with a pressure algometer until pain is induced, and the test in that area will be terminated when the patient feels pain.

  Baseline

Secondary Outcomes (10)

• Central Sensitization Inventory

  Baseline

• Tampa Scale for Kinesiophobia (TSK)

  Baseline

• Pain Catastrophizing Scale (PCS)

  Baseline

• Patient-Rated Tennis Elbow Evaluation

  Baseline

• Hospital Anxiety and Depression Scale

  Baseline

Study Arms (2)

lateral epicondylitis

individuals with lateral epicondylitis

Other: Pressure pain threshold; Other: Ultrasonography

Control Group

Healthy people

Other: Pressure pain threshold; Other: Ultrasonography

Interventions

Pressure pain threshold OTHER

Pressure pain threshold is defined as the minimal pressure level that causes pain. The measurement will be applied twice for each region with a 1-minute interval, and the average of these applications will be recorded. A trial test will be conducted on the patient before the actual test. Pressure will be applied to selected points with a pressure algometer until pain is induced, and the test for that area will be terminated when the patient feels pain.

Also known as: evaluation of pain threshold with a pressure pain algometer

Control Group; lateral epicondylitis

Ultrasonography OTHER

The cross-sectional area of the radial nerve will be measured in the antecubital fossa and the spiral groove. Three measurements will be taken for the nerve cross-sectional area, and the average will be calculated. For the measurement of common extensor tendon thickness, the probe will be placed over the lateral epicondyle, and the evaluation will be conducted with the elbow in 90 degrees of flexion and the forearm in mid-supination. The Sonosite M-Turbo device will be used for ultrasonography and will be performed by a rehabilitation specialist with 10 years of experience.

Also known as: ultrasonographic evaluation

Control Group; lateral epicondylitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients applying to the Physical Medicine and Rehabilitation outpatient clinic of Derince Training and Research Hospital and the Physical Medicine and Rehabilitation outpatient clinic of Sultan Abdulhamid Han Training and Research Hospital will be evaluated. Those who volunteer to participate in the study and meet the inclusion criteria will have their measurements and surveys completed at Sultan Abdulhamid Han Training and Research Hospital.

You may qualify if:

• Have unilateral lateral elbow pain persisting for at least 3 months Have a visual analog scale score of 4/10 or higher Have tenderness upon palpation of the common extensor tendon and/or lateral epicondyle region Experience elbow pain that occurs or worsens with hand grip or lateral elbow pain that occurs with resistant static contraction or stretching of the wrist extensors Have read and signed the volunteer consent form (VCF)

You may not qualify if:

• Having undergone surgery on the upper extremity or cervical region before
• Presence of cervical or shoulder pathology
• Mechanical symptoms in the elbow (locking, limited range of motion) and other elbow pathologies
• History of trauma to the elbow
• Presence of upper extremity neurological deficit
• History of fibromyalgia, central nervous system disease, or rheumatic disease
• Last 1 month history of physical therapy or injection for lateral epicondylitis
• Pregnancy
• HEALTHY GROUP
• Not having experienced elbow pain before
• Having read and signed the volunteer agreement form (BGOF)
• Presence of upper extremity, shoulder, or neck pain within the last year
• History of upper extremity fractures
• Presence of neurological deficits

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Keating C, Puentedura E, Lucado A, Cleland J. Exploring the Relationship Between Central Sensitization, Pain Characteristics, and Function in a Cross-Sectional Study of Individuals With Lateral Elbow Tendinopathy. Clin J Pain. 2026 Jan 1;42(1):e1335. doi: 10.1097/AJP.0000000000001335.

  PMID: 41084876 BACKGROUND

• Abhimanyu V, Ritika P, Osama N, Srishti N, Gita H. Lateral epicondylitis: Are we missing out on radial nerve involvement? A cross-sectional study. J Bodyw Mov Ther. 2021 Jul;27:352-357. doi: 10.1016/j.jbmt.2021.01.014. Epub 2021 Jan 28.

  PMID: 34391257 BACKGROUND

• Cancela-Cilleruelo I, Rodriguez-Jimenez J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Pressure Pain Hypersensitivity and Ultrasound Changes in the Radial Nerve in Patients with Unilateral Lateral Epicondylalgia: A Case-Control Study. Diagnostics (Basel). 2023 Jul 26;13(15):2488. doi: 10.3390/diagnostics13152488.

  PMID: 37568851 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Mustafa Hüseyin Temel, Assoc. Prof.

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Hüseyin Temel, Assoc. Prof.

CONTACT

2165422000; mhuseyintemel@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: August 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

TU (1)