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

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771701
• Other study ID #: LE1
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2023
• Source: Uskudar State Hospital
• Contact: Mustafa H Temel, M.D.
• Phone: +905342714872
• Email: mhuseyintemel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Lateral Epicondylitis, Unspecified Elbow
• Tennis Elbow

Intervention

Device:
• Pain pressure threshold measurement
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle. PPT has no standard protocol on administration and placement. Equipment used varies with many handheld electric algometers. PPT has been used on a wide variety of patients and conditions, including musculoskeletal and neuromuscular disorders (eg, Parkinson disease, tension headaches, pelvic pain, low back pain, myofascial trigger points, sacroiliac joint pain, knee osteoarthritis, skin humidity, shoulder pain, lateral epicondylitis).

Locations

Country	Name	City	State
Turkey	Basaksehir Çam ve Sakura City Hospital	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater reliability	Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1	1 day
Primary	Intra-rater reliability	Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1	1 day