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临床试验/NCT03582644
NCT03582644已完成不适用

Cryotherapy Effectiveness on Pain, Physical Function and Quality of Life in Individuals With End Stage Knee Osteoarthritis - a Case Series

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Visual Analogue Scale (Pain scale)

研究概览

简要总结

The purpose of this case series will be to provide a detailed description of a standardized short-term cryotherapy application protocol using validated functional outcome measures in individuals with end stage KOA

详细描述

There are no studies determining the efficacy of cryotherapy in pain, function and quality of life for patients with end stage Knee Osteoarthritis (KOA). This case series describes a standardized treatment program for end stage patients with KOA and outcomes over a 12-week period.

研究设计

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

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of American College of Rheumatology
  • Osteoarthritis signals in at least one of the compartments of the knee joint (tibiofemoral and / or the patellofemoral joint)
  • Do not perform regular physical activity
  • Grade 4 according to the criteria of Kellgren & Lawrence knee osteoarthritis radiographic examination scale.
  • Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
  • Body Mass Index less or equal to 40 kg/cm2

排除标准

  • Physical therapy within 3 months prior to the research project
  • Corticosteroid or Hyaluronic Acid injection in the knee (in the previous 6 months)
  • Cardiorespiratory, neurological or other rheumatic dysfunctions associated with the diagnosis of knee osteoarthritis.
  • Hip, knee or ankle surgery
  • Any other type of chronic condition that can lead to pain.

研究组 & 干预措施

CRYOTHERAPY INTERVENTION

Experimental

Patients with end stage knee osteoarthritis, both sexes, 60 years or higher

干预措施: Cryotherapy (Other)

结局指标

主要结局

Visual Analogue Scale (Pain scale)

时间窗: Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week)

VAS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be positioned in front of the individual and will have a range of 0 to 10 cm, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.

次要结局

  • Western Ontario & McMaster Universities Osteoarthritis (WOMAC)(Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))
  • 30-Second Chair to Stand Test(Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))
  • Short Form 36(Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))
  • Pain catastrophizing scale(Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))
  • 40m fast paced walk test(Change between the baseline assessments and the Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))
  • Stair climb test(Baseline assessment 1 (First week), Baseline assessment 2 (Second week), Baseline assessment 3 (Third Week), Post intervention (Sixth week), 3 week follow up (9th week), 6 week follow up (12th week))

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucas Ogura Dantas

Principal Investigator

Universidade Federal de Sao Carlos

研究点 (2)

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