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

NCT05771701 | Unknown FDA Device

• 1 other identifier: LE1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lateral Epicondylitis; Lateral Epicondylitis, Unspecified Elbow

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Lateral epicondylitis patients

EXPERIMENTAL

Patients that are diagnosed with lateral epicondylitis.

Device: Pain pressure threshold measurement

Interventions

Pain pressure threshold measurement DEVICE

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).

Lateral epicondylitis patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar State Hospital: lead

Study Sites (1)

Başakşehir Çam ve Sakura City Hospital

Istanbul, Başakşehir, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Mustafa H Temel

  Uskudar State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

+905342714872; mhuseyintemel@gmail.com

Fatih Bağcıer, M.D.

CONTACT

+90 544 242 90 42; bagcier_42@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The raters will be unaware of each other's test results. Furthermore, the participants will not be informed of their results. Assessor and investigator will be blinded from the providers and participants.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Before starting the investigation, the raters will practice the procedure together in a 30-min training session on a person with lateral epicondylitis. The rater will stabilize the participant's elbow with one hand. The most tender spot in the joint line of each elbow identified by palpation will be assessed with PPT algometry three times with ≥20-second intervals by each rater in a single session. The rubber tip will be placed perpendicular to the skin. The participants will be instructed to give a verbal signal as soon as the sensation of pressure turns into pain, at which time the rater will immediately remove the algometer and record the score. The display of the algometer will face the floor during the testing to blind the raters and participants for the levels of force. There will only be one rater and participant present during the testing at a time. The pause between each rater will be approximately one minute, and the rater order will change randomly during the study period.

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 16, 2023
• Study Start: June 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 1 year
• Access Criteria: Individual participant data will be shared by the corresponding author upon reasonable request.

Locations

TU (1)