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Central Sensitization and Ultrasound in Lateral Epicondylitis

14 settembre 2026 aggiornato da: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Central Sensitization, Ultrasonographic Findings, Functional Status, and Psychosocial Factors in Lateral Epicondylitis

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Lateral epicondylitis (LE), commonly known as tennis elbow, is a prevalent musculoskeletal disorder characterized by pain and tenderness over the lateral epicondyle. It is generally associated with repetitive mechanical loading, microtrauma, and degenerative changes affecting the common extensor tendon origin. Because LE may impair upper-extremity function, daily activities, and work productivity, it represents an important clinical and socioeconomic problem. Although conservative treatment is generally effective, symptoms may persist or become chronic in some individuals.The pathophysiology of chronic LE may extend beyond local tendon pathology. Emerging evidence suggests that altered nociceptive processing and central sensitization may contribute to persistent pain. Pressure pain threshold (PPT) assessment at both local and remote sites may help identify localized and widespread pressure pain hypersensitivity. The radial nerve may also be relevant because radial nerve entrapment and LE can produce overlapping clinical findings and may coexist. Ultrasonographic evaluation of both the common extensor tendon and radial nerve may therefore provide additional information about the peripheral components of the condition.

Psychosocial factors, including pain catastrophizing, kinesiophobia, depressive symptoms, and anxiety, may also influence pain severity, functional impairment, and the development or maintenance of sensitization. Although these factors have been extensively investigated in chronic musculoskeletal pain, their combined relationships with pain sensitivity, functional status, and ultrasonographic findings in chronic LE remain insufficiently characterized.

The primary objective of this cross-sectional case-control study is to compare remote PPT values between individuals with chronic LE and healthy controls. The secondary objectives are to compare local PPT, central sensitization, pain catastrophizing, kinesiophobia, depression, anxiety, functional status, radial nerve cross-sectional area, and common extensor tendon thickness between the groups. In the patient group, the study will also examine the relationships of functional status with local and remote PPT values, central sensitization, psychosocial factors, and ultrasonographic findings.

Tipo di studio

Osservativo

Iscrizione (Stimato)

128

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye)
        • Reclutamento
        • Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

  1. CASE GROUP

    Inclusion Criteria:

    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)

    Exclusion Criteria:

    • 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
  2. HEALTHY GROUP

Inclusion Criteria:

  • Not having experienced elbow pain before

  • Having read and signed the volunteer agreement form (BGOF)

    2.Exclusion criteria

  • Presence of upper extremity, shoulder, or neck pain within the last year
  • History of upper extremity fractures
  • Presence of neurological deficits

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Gruppo di controllo
Persone sane
Altro: Pressure pain threshold
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.
Altri nomi:
  • evaluation of pain threshold with a pressure pain algometer
Altro: Ultrasonography
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.
Altri nomi:
  • ultrasonographic evaluation
lateral epicondylitis
individuals with lateral epicondylitis
Altro: Pressure pain threshold
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.
Altri nomi:
  • evaluation of pain threshold with a pressure pain algometer
Altro: Ultrasonography
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.
Altri nomi:
  • ultrasonographic evaluation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pressure Pain Threshold (PPT)
Lasso di tempo: Baseline
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Central Sensitization Inventory
Lasso di tempo: Baseline
CSI scores range from 0-100, with higher scores indicating greater severity of central sensitization-related symptoms.
Baseline
Tampa Scale for Kinesiophobia (TSK)
Lasso di tempo: Baseline
The TSK consists of a total of 17 items, and individuals evaluate each item using a 4-point Likert scale (1=strongly disagree, 4=strongly agree). The total score obtained from the scale reflects the individual's level of kinesiophobia. Increasing TSK scores indicate an increase in avoidance behaviors and fear related to pain.
Baseline
Pain Catastrophizing Scale (PCS)
Lasso di tempo: Baseline
The PCS consists of a total of 13 items, and each item is evaluated on a 5-point Likert scale (0=never, 4=always). The total and subscale scores obtained from the scale reflect the individual's level of catastrophic thinking toward pain. High PCS scores indicate an increase in negative cognitive and emotional responses to pain.
Baseline
Patient-Rated Tennis Elbow Evaluation
Lasso di tempo: Baseline
To evaluate upper extremity functionality, it is a questionnaire specifically designed for patients with lateral epicondylitis, providing patient follow-up and being condition-specific, with scoring ranging from 0 (no pain/disability) to 100 (possible worst pain and disability), and containing pain and function sub-scales. The total score is calculated out of 100 by summing the pain and function subscales. Low scores indicate better function.
Baseline
Hospital Anxiety and Depression Scale
Lasso di tempo: Baseline
It is a 14-item self-report scale that quickly, reliably, and independently of medical conditions assesses patients' anxiety and depression symptoms over the past week.
Baseline
short form-12
Lasso di tempo: Baseline
The health-related quality of life of the participants will be evaluated using the Short Form-12 (SF-12) Quality of Life Scale. SF-12 is a 12-item self-report scale that assesses individuals' physical function, physical role limitations, pain, general health perception, vitality, social function, emotional role limitations, and mental health status over the past four weeks. From the scale, the physical component score (Physical Component Summary, PCS) and the mental component score (Mental Component Summary, MCS) are obtained.
Baseline
Pressure Pain Threshold - Local
Lasso di tempo: Baseline
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 the selected point with a pressure algometer until pain is induced, and the test for that area will be terminated when the patient feels pain. The measurement will be taken from the symptomatic common extensor tendon area, and a Wagner manual pressure algometer (1 cm² probe-10 kg/20 lb) will be used.
Baseline
Radial Nerve CSA (in spiral groove and antecubital fossa)
Lasso di tempo: Baseline
The cross-sectional area of the radial nerve will be measured in the antecubital fossa and spiral groove. In the spiral groove, the measurement will be taken with the patient's arm resting on the table, the elbow bent at 90°, the forearm in a pronation position, and the hand loosely resting on the table, with the probe perpendicular to the arm axis and placed on the lateral side of the distal third of the humerus. If measuring from the antecubital fossa, the patient will have their arm resting on the table, elbow extended, and forearm in a supine position; the probe will be placed transversely to the arm axis at the front of the elbow flexion, observing the elbow joint space. The radial nerve, located between the brachioradialis muscle and the anterior brachialis muscle, will be visualized before it divides into two branches. Two measurements will be taken for the nerve cross-sectional area, and the average will be calculated.
Baseline
Common extansor tendon thickness
Lasso di tempo: Baseline
For the measurement of common extensor tendon thickness, the probe will be placed on the lateral epicondyle, and the evaluation will be conducted with the elbow in 90 degrees of flexion and the forearm in mid-supination. To determine the evaluation point, a horizontal line of 1 cm will be placed from the upper edge of the lateral epicondyle. At this point, a vertical line will be drawn from the upper edge of the tendon tissue to the hyperechoic line of the humerus for measurement. The Sonosite M-Turbo device will be used for ultrasonography and it will be performed by a physical therapy and rehabilitation specialist with 10 years of experience.
Baseline
Grip Strength Measurement
Lasso di tempo: Baseline
It will be measured using a modified sphygmomanometer test (MST). a manual aneroid sphygmomanometer (gauge manometer + inflation bulb + cuff) will be used. First, the blood pressure measurement device will be transformed into a cylinder that the patient can comfortably grasp while resting. then the cuff will be inflated to 20 mmHg and the patient will apply maximum grip strength to the cuff. Grip measurements will be taken while the participant sits in a chair without armrests, with their feet supported, shoulders internally rotated, forearms in a neutral position, and elbows flexed at 90°. Before the assessment, information about the procedures and a trial will be conducted. They will be instructed to perform maximum isometric contraction for 5 seconds, and the highest force value (mmHg) will be recorded. The measurement will be taken 3 times with a 15-second rest interval, and the average will be calculated.
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigatori

  • Investigatore principale: Mustafa Hüseyin Temel, Assoc. Prof., Saglik Bilimleri Universitesi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 agosto 2026

Completamento primario (Stimato)

15 dicembre 2026

Completamento dello studio (Stimato)

15 dicembre 2026

Date di iscrizione allo studio

Primo inviato

14 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

18 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 34/2026

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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