Pain Pressure Threshold Algometry in Lateral Epicondylitis: Intra- and Inter-rater Reliability

Not Applicable

Recruiting

• Conditions: Lateral Epicondylitis; Lateral Epicondylitis, Unspecified Elbow
• Interventions: Device: Pain pressure threshold measurement

• Registration Number: NCT05771701
• Lead Sponsor: Uskudar State Hospital

Brief Summary

This clinical trial aims to investigate the intra- and inter-rater reliability of pain pressure threshold algometry in lateral epicondylitis patients.

Detailed Description

Tennis elbow, also known as lateral epicondylitis (or epicondylosis) of the elbow, was first described at the end of the 19th century. The community prevalence is 1% to 3%,38 with an even sex distribution and a peak incidence between 35 and 55 years of age.16 There is consensus that the mechanism of injury involves repetitive loads at the wrist and elbow, including supination and extension of the wrist.15 People affected by tennis elbow commonly have pain over the lateral humeral epicondyle, with flexion at the elbow also usually limited by pain, especially if the wrist is pronated and extended against resistance.

Assessment of reliability is a necessary first step in the validation procedures of clinical tests. The reliability of the PPT measurement is susceptible to the influence of rater behavior and judgment, such as the instructions to the participant, rate of force application, and reaction time of the rater.

We opted to investigate the intra- and inter-rater reliability of PPT in persons with lateral epicondylitis with three raters, rater blinding, and a pause of ≥20 seconds between each measurement. We hypothesized that clinicians with no former experience with the procedure can master it with good reliability after a single 30-min training session.

Study Timeline

• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-16
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-07
• Primary Completion: 2023-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Must be between 18 and 90 years of age
• Clinical diagnosis of lateral epicondylitis (point tenderness over the lateral epicondyle and exacerbation of pain with chair pick-up test and maximal hand grip)

Exclusion Criteria

• History of steroid injection for the treatment of lateral epicondylitis within six months
• History of oral steroid use for the treatment of lateral epicondylitis within six months
• History of elbow surgery
• History of elbow fracture
• History of elbow dislocation
• Cancer
• Rheumatoid arthritis
• Severe cognitive deficit
• Neurological deficits in the upper limb
• Inability to speak and understand English/Turkish.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lateral epicondylitis patients	Pain pressure threshold measurement	Patients that are diagnosed with lateral epicondylitis.

Primary Outcome Measures

Name	Time	Method
Inter-rater reliability	1 day	Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1
Intra-rater reliability	1 day	Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1

Trial Locations

Locations (1)

Başakşehir Çam ve Sakura City Hospital; 🇹🇷 Istanbul, Başakşehir, Turkey