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临床试验/NCT04830748
NCT04830748已完成不适用

Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis

Cairo University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年5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
40
试验地点
2
主要终点
Measurement of knee pain severity change after 4 weeks of intervention

研究概览

简要总结

The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance.

Hypotheses

  1. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis.
  2. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis.
  3. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis.
  4. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis.
  5. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis.
  6. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis.

详细描述

Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population.

Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping).

It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise.

Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement.

Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients.

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
Double (Participant, Outcomes Assessor)

盲法说明

Patients will be blinded to study hypotheses and informed only about comparing different programs of treatment of knee osteoarthritis. After randomization, participants will only be provided with details of the program they will be undertaking.

入排标准

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

入选标准

  • Patients will have grade II of primary knee osteoarthritis.
  • Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study.
  • Age of patients will range from 45 years to 65 years old.
  • Duration of illness will range from 3- 12 months.

排除标准

  • Malignancy
  • presence of skin lesions or infections at the treatment sites

结局指标

主要结局

Measurement of knee pain severity change after 4 weeks of intervention

时间窗: baseline, 4 weeks

Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain.

次要结局

  • Measurement of Functional Disability change after 4 weeks of intervention(baseline, 4 weeks)
  • Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention(baseline, 4 weeks)
  • Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test(baseline, 4 weeks)
  • Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test(baseline, 4 weeks)

研究者

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

moaaz ragab riyad amin

Teaching assistant at faculty of physical therapy

Cairo University

研究点 (2)

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