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临床试验/NCT05781230
NCT05781230已完成不适用

The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia: Randomised Controlled Trial

Hacettepe University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Change of Pressure pain theshold

研究概览

简要总结

The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

详细描述

Background: The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity.

Methods : A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients were block-randomized based on intensity of exercises. The randomization sequence was produced by an external investigator using a computer-generated randomization sequence (Microsoft Excel, Microsoft, Redmond, WA, USA) to generate either a 0 or 1, corresponding with high intensity exercises or low intensity exercises, respectively

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients had undergone primary unilateral total knee replacement surgery
  • Patients hospitalized for at least seven days were enrolled in this study.

排除标准

  • Medically stable patients who used glucocorticoids or strong analgesic drugs
  • Patients had post-traumatic OA, rheumatoid arthritis (RA), psoriatic arthritis, cognitive, hearing and visual problems Patients were diagnosed chronic pain condition were excluded from the study.

结局指标

主要结局

Change of Pressure pain theshold

时间窗: admission to hospital service to discharge from hospital service, an average 5 days

Pressure pain threshold (PPTs) were assessed using a handheld pressure algo-meter

change of pain severity

时间窗: admission to hospital service to discharge from hospital service, an average 5 days

. The pain severity evaluated using a visual analogue scale (VAS; scored from 0, no pain, to 100, the worst pain ever).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MERVE KARAPINAR

Assistant Professor

Hacettepe University

研究点 (1)

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