Central Sensitization and Ultrasound in Lateral Epicondylitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
CASE GROUP
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Pressure pain threshold
Other interventionPressure 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.
Ultrasonography
Other interventionThe 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: lateral epicondylitis2 interventions
Group B: Control Group2 interventions
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
Central Sensitization Inventory
CSI scores range from 0-100, with higher scores indicating greater severity of central sensitization-related symptoms.
Time frame
Baseline2
Tampa Scale for Kinesiophobia (TSK)
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.
Time frame
Baseline3
Pain Catastrophizing Scale (PCS)
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.
Time frame
Baseline4
Patient-Rated Tennis Elbow Evaluation
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov