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

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

Study Overview

• Status: Recruiting
• Conditions: Lateral Epicondylitis; Lateral Epicondylitis, Unspecified Elbow
• Intervention / Treatment: Device: Pain pressure threshold measurement

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa H Temel, M.D.; Phone Number: +905342714872; Email: mhuseyintemel@gmail.com
• Study Contact Backup: Name: Fatih Bağcıer, M.D.; Phone Number: +90 544 242 90 42; Email: bagcier_42@hotmail.com

Study Locations

• Turkey
  • Başakşehir
    • Istanbul, Başakşehir, Turkey, 34000
      • Recruiting
      • Basaksehir Cam ve Sakura City Hospital
      • Contact: Fatih Bağcıer, Assoc. Prof.
      • Sub-Investigator: Fatih Bağcıer, Assoc. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lateral epicondylitis patients; Patients that are diagnosed with lateral epicondylitis.

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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uskudar State Hospital
• Investigators: Principal Investigator: Mustafa H Temel, Uskudar State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Elbow Injuries; Tennis Elbow
• Other Study ID Numbers: LE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared by the corresponding author upon reasonable request.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Individual participant data will be shared by the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes