跳至主要内容
临床试验/NCT05636059
NCT05636059已完成不适用

Comparative Effects of Different Physiotherapy Methods on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis

Lithuanian Sports University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年3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
63
试验地点
1
主要终点
Change from baseline Pain at 18 days

研究概览

简要总结

Osteoarthritis symptoms can be managed with non-drug treatments such as patient education, exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce joint inflammation, pain and improve function. Another method is joint mobilization, which can also reduce pain and improve function. Based on this theory, it was hypothesized that cryotherapy will have better effect on pain and the quality of life, whereas joint mobilization will be more effective on knee function. The aim of the study was to compare the effects of different physiotherapy methods on pain, knee joint function and quality of life in individuals with osteoarthritis.

详细描述

Study included 63 participants with knee osteoarthritis. All subjects were randomly assigned to one of 3 groups: exercise group (n=21), exercise + cryotherapy group (n=21), or exercise + joint mobilization group (n=21). VAS scale was used to assess the pain, quality of life was evaluated with Short Form 36 Health Survey Questionnaire (SF-36) questionnaire, knee ranges of motion were measured using a goniometer, strength of the muscles was assessed on the Oxford 5 point scale, The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to evaluate knee osteoarthritis. All the participants received 30 intervention sessions.

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)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • stage II of the knee OA;
  • affected knee joint;
  • pain of at least 3 points on the VAS.

排除标准

  • Severe cardiovascular disease;
  • Oncological Disorders;
  • Allergy to cold / cold intolerance;
  • Impaired lower limbs blood circulation;
  • Fear of confined spaces;
  • Pregnancy or lactation.

结局指标

主要结局

Change from baseline Pain at 18 days

时间窗: Baseline and after 18 days

Pain was assessed using a visual analogue scale (VAS) that used a 10-cm line with end-point descriptors such as 'no pain' marked at the left end and 'worst pain imaginable' marked at the right end. Patients were asked to mark a point on the line that best represented their pain at the time of the evaluation. The distance from 'no pain' to the patient's mark was then measured and recorded as the VAS score: 0 cm was defined as no pain, 1-3 cm as mild pain, 4 or 5 cm as moderate pain, 6-8 cm as severe pain and 9 or 10 cm as the worst pain imaginable.

Change from baseline Knee Ranges of Motions at 18 days

时间窗: Baseline and after 18 days

Using goniometer the range of knee motions were evaluated: flexion, extension. Each motion was measured three times and averaged value was used.

Change from baseline Knee Health Status at 18 days

时间窗: Baseline and after 18 days

Self-administered Western Ontario and McMaster Universities (WOMAC) index was used to to quantify the health status of patients with knee osteoarthritis. It is the most common used clinical tools for evaluating patients with knee OA. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living.

Change from baseline Quality of Life at 18 days

时间窗: Baseline and after 18 days

The SF-36 quality of life questionnaire is used to assess health-related quality of life. The questionnaire consists of 36 questions and reflects 8 areas of life: physical activity, activity limitation due to physical ailments and/or emotional disorders, social relationships, emotional state, energy and vitality, pain, general health assessment. The questionnaire can be completed by the subject or by a specialist conducting the study. Answers are scored. Numerical value of each area from 0 to 100 points. The more points collected, the better the quality of life. Test reliability is 0.791.

Change from baseline Knee Muscle Strength at 18 days

时间窗: Baseline and after 18 days

The muscle strength of knee flexion and extension was evaluated using manual muscle testing technique (Oxford 5 point scale).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验