Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
2026年6月24日 更新者：Mohammed Said ElSharkawy、Tanta University
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
研究概览
详细说明
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mohammed S Elsharkawy, MD
- 电话号码：00201148207870
- 邮箱：mselsharkawy@med.tanta.edu.eg
学习地点
-
-
El-Gharbia
-
Tanta、El-Gharbia、埃及、31527
- 招聘中
- Tanta University
-
接触：
- Mohammed S Elsharkawy, MD
- 电话号码：00201148207870
- 邮箱：mselsharkawy@med.tanta.edu.eg
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 50 years.
- Both genders.
- Chronic knee osteoarthritis (KOA) according to American College of Rheumatology criteria for the diagnosis of knee osteoarthritis.
- Third or fourth grade Kellgren and Lawrence system for classification of osteoarthritis based on radiological data, it is a common method of classifying the severity of osteoarthritis (OA) using five grades according to the following sites and projections.
Exclusion Criteria:
- History of intra-articular injection within the last 6 months,
- History of surgery on the knee joint or major trauma to the lower limb causing fracture.
- Body mass index (BMI) more than 40 kg/m2.
- Medical conditions affecting the joint or lower extremity function such as severe osteoporosis, rheumatoid arthritis, collagen vascular diseases, and gout.
- Diabetic patient.
- Any contraindication to intra-articular injections for instance immunodeficiency, coagulation defect or anticoagulation therapy taking or skin infection at the site of injection.
- Hypersensitivity to Botulinum toxin or hyaluronic acid.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group HA
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
|
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
|
|
实验性的：Group BTX
Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
|
Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Degree of pain
大体时间：3 months after the interventions
|
Each patient will be instructed about postoperative pain assessment with VAS.
VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
|
3 months after the interventions
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of quality of life
大体时间：3 months after the interventions
|
The Short form (SF)-36 generic quality of life questionnaire, which is composed of eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health.
|
3 months after the interventions
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
大体时间：3 months after the interventions
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) which is a specific functional questionnaire that assesses pain (5 subitems), stiffness (2 items), and function (17 items).
|
3 months after the interventions
|
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
大体时间：3 months after the interventions
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes, Pain (nine items); Symptoms (seven items); Activities of Daily Living Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
|
3 months after the interventions
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月24日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月18日
首先提交符合 QC 标准的
2026年6月18日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 36265PR78/5/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.