Effects of Hyaluronic Acid Injection and Exercise Therapies on Proprioception, Gait Analysis and Quality of Life in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale-pain,
研究概览
简要总结
Background: Osteoarthritis (OA) is one of the most common joint diseases that most often causes physical disability. Physical therapy modalities, exercise programs and intra-articular injections are widely used in the treatment of OA.
Purpose: The aim of this study is to investigate the effects of adding different exercise treatments to hyaluronan injection on proprioception, muscle strength and quality of life in patients with knee OA.
Methods: A total of 54 patients were included in the study and were randomized into three groups. Quadriceps strengthening exercises were applied to the patients in Group 1, a home exercise program was applied to the patients in Group 2, and no exercise program was applied to the patients in Group 3. Additionally, all patients received patient education and intra-articular hyaluronic acid injection into the symptomatic knee. Standard forms were filled out to evaluate the patients' pain, functional status and quality of life. Muscle strength and proprioception were evaluated with an isokinetic dynamometer. Changes in the patients' walking parameters were evaluated by gait analysis. Evaluations were made at the beginning of treatment, at the end of treatment, and at the 3rd and 6th months of treatment.
详细描述
Background: Osteoarthritis (OA) is one of the most common joint diseases that most often causes physical disability. The most common type of osteoarthritis with the highest incidence in the clinic is knee osteoarthritis. Physical therapy modalities, exercise programs and intra-articular injections are widely used in the treatment of knee OA.
Purpose: The aim of this study is to investigate the effects of adding different exercise treatments to hyaluronan injection on proprioception, muscle strength and quality of life in patients with knee OA.
Methods: A total of 54 patients with stage II and III primary knee OA were included in the study. The patients included in the study were divided into 3 groups by randomization. For randomization, envelopes containing the letters A, B and C were prepared for the patients included in the study. The patients included in the study randomly selected one of the envelopes. Patients who chose the envelope with the letter A were included in the 1st group, patients who chose the envelope with the letter B were included in the 2nd group, and patients who chose the envelope with the letter C were included in the 3rd group. The researchers who made the assessment measurements were unaware of which patient was in which group. Statistical analysis of the results was performed by a biostatistician who had no information about the therapies the patient groups received. Quadriceps strengthening exercises were applied to the patients in Group 1 with the isokinetic dynamometer device, a home exercise program was applied to the patients in Group 2, and no exercise program was applied to the patients in Group 3. Additionally, all patients received patient education and intra-articular hyaluronic acid injection (once a week, 3 times in total) into the symptomatic knee. Standard forms were filled out to evaluate the patients' pain, functional status and quality of life. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne knee index and The Health Assessment Questionnaire (HAQ) scales were used to evaluate the patients' functional status and quality of life. Visual Analogue Scale (VAS) was used to evaluate the pain conditions of the patients. Muscle strength and proprioception were evaluated with an isokinetic dynamometer. Changes in the patients' walking parameters were evaluated by gait analysis. Evaluations were made at the beginning of treatment, at the end of treatment, and at the 3rd and 6th months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Patients diagnosed with primary knee osteoarthritis according to American College of Rheumatology (ACR) diagnostic criteria
- •Patients with a radiological diagnosis of stage 2 and 3 primary knee osteoarthritis according to the Kellgren & Lawrence Scale
- •Patients with knee osteoarthritis between the ages of 45-65
- •Patients giving informed written consent
排除标准
- •Patients diagnosed with secondary knee osteoarthritis
- •Patients with decompensated organ failure that prevents them from exercising
- •Patients with lower extremity neurological deficits affecting gait and proprioception
- •Patients who had fracture affecting the knee joints, patients who underwent a surgical intervention, patients who underwent intraarticular injection for knees within the last 6 months,
- •Inflammatory rheumatic disorders
- •Patients using anticoagulant medication
- •Patients with bleeding disorders
- •Malignancy
- •Patients who are pregnant
- •Patients who are with diabetes
- •Patients who are with active vestibular disease
结局指标
主要结局
Visual Analogue Scale-pain,
时间窗: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Detection of changes in Visual Analogue Scale-pain. VAS consists of a 10 cm (or 100 mm) long line drawn on a horizontal axis. The distance from the lowest VAS value to the patient's mark is measured in mm (0-100). 0 no pain, 100 mm worst pain
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Detection of changes in Western Ontario and McMaster Universities Osteoarthritis Index. It consists of three parts: pain (5 items), stiffness (2 items) and physical function (17 items). It contains 24 items in total. The scoring of the items is based on the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4 which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Lequesne knee index
时间窗: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.
Detection of changes in Lequesne knee index. It is a 10-item scale consisting of 3 parts: pain/discomfort, activities of daily living and maximum walking distance.
The Health Assessment Questionnaire
时间窗: At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment
Detection of changes in The Health Assessment Questionnaire. The Health Assessment Questionnaire has a total of 20 questions covering 8 areas related to dressing, sitting up, eating, walking, hygiene, reaching, grasping and daily tasks. The test score is calculated by dividing the total score by the number of marked questions. Scoring is between 0 and 3 points. (0: Doing the activity without difficulty, 1: Doing it with some difficulty, 2: Performing it with great difficulty, 3: Not being able to do it at all)
次要结局
- Proprioception(At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment)
- Muscle strength(At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.)
- Walking parameters(At the beginning of treatment, at the 4th, 16th and 28th weeks after the start of treatment.)
研究者
Bilal Uysal
Assistant Professor
Balikesir University