跳至主要内容
临床试验/NCT05771701
NCT05771701招募中不适用

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

Uskudar State Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Inter-rater reliability

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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
  • Rheumatoid arthritis
  • Severe cognitive deficit
  • Neurological deficits in the upper limb
  • Inability to speak and understand English/Turkish.

结局指标

主要结局

Inter-rater reliability

时间窗: 1 day

Inter-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1

Intra-rater reliability

时间窗: 1 day

Intra-rater reliability of pressure pain threshold measurements using Intraclass Correlation Coefficient (ICC) two-way random model 2.1

次要结局

未报告次要终点

研究者

发起方
Uskudar State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mustafa Hüseyin Temel

Principal Investigator

Uskudar State Hospital

研究点 (2)

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