Extracorporeal Shockwave Versus Phonophoresis on Functional and Anatomical Changes Detected With Artificial Intelligence Technology in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Anatomical improvement
研究概览
简要总结
A parallel double blinded randomized controlled clinical trial (RCT) with a 1:1:1 allocation will be conducted in an orthopedic clinic in Cairo and Giza Governments - Egypt.
This RCT will evaluate the pain reduction, self-reported functional improvement, physical functional and anatomical improvement following the application of phonophoresis using chitosan-nanoparticles gel, ECSW therapy and traditional exercises compared to each other.
The treatment period will last for 4 weeks with a total of (12 sessions/ 3 sessions per week for the application of phonophoresis using chitosan-nanoparticles gel and traditional exercises program) and (5 sessions/ 1 every week for the application of ECSWT). The participants will be assessed at two different time-points (before-after treatment) with a sample size of 40 patients in each group (3 groups)
详细描述
Osteoarthritis (OA) is a common degenerative disease that is ranked as the 10th largest contributor to disabilities that has a link to higher comorbidity and excess mortality. One of most common degenerative diseases is knee osteoarthritis (KOA). KOA is a progressive, chronic degenerative condition that places a heavy socioeconomic burden on healthcare systems and society. The prevalence of knee OA has sharply increased to more than the double in the last 10 years as result of steady state in life expectancy.
KOA is a well-known as a cartilage disease that involves degradation and loss of articular cartilage. However, OA is usually accompanied by changes in the subchondral bone, with sclerosis, bone cyst, and osteophyte formation.
Recent studies reported that subchondral bone remodeling plays a very important role in KOA, mediating and preceding cartilage damage. The increase in subchondral bone stiffness decreases the ability to scatter the loading forces within the knee joint, which then increases the force loaded on articular cartilage. Therefore, the cartilage damage and progress of OA accelerated over time. The focus of treatment in early KOA have shifted from the articular cartilage to the subchondral bone and become a potential therapeutic target of various therapeutic methods.
Regarding KOA pain, accumulating evidence suggests that bottom-up vascularization from subchondral bone plays a larger role than top-down vessel invasion originating from synovial tissue or synovium during cartilage erosion in OA. As a result, it is a common complaint of orthopedists that osteoarthritis pain is not associated with the radiographic presentation. Recent work revealed a relatively weak relationship between cartilage loss and OA joint pain.
As different approaches aimed at articular cartilage or synovial components had inefficient results and the mechanism of bone cartilage crosstalk is gradually becoming clear, this study will try to confirm the critical role of subchondral bone in knee osteoarthritis and that subchondral bone could be an ideal outcome measure of osteoarthritis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded controlled randomized study (pretest-posttest measurement)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between ≥40 and ≤ 65 years old.
- •Both genders.
- •Patients should have OA of the knee, Kellgren-Lawrence scores of 2 and 3 on radiologic evaluation.
- •If both knees diagnosed as OA, the most affected one will be selected.
- •Diagnosis of KOA who had knee pain and functional disabilities for at least three months, according to American College of Rheumatology classification (ACR) at screening visit.
- •Visual Analogue Scale (VAS) at rest score of ≥40 mm.
- •Subjects have sufficient cognition that enables them to understand the requirements of the study, comply with the study procedures and visit schedule.
排除标准
- •Patients with any previous knee surgeries or lower limb fractures.
- •Chronic inflammatory diseases such as rheumatoid arthritis.
- •Any neurological disorders.
- •Moderate to significant knee synovitis.
- •Hot or red knee.
- •History and/or physical examination findings compatible with the internal derangement of knee.
- •Patients with BMI more than 35 (morbid obesity).
- •Absence of current physical therapy treatments for KOA.
- •Cognitive limitations or endocrine disease.
- •Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during previous 6 months.
- •Use of NSAIDs one week prior to screening visit.
- •Orthopedic diseases that may affect or interfere with the therapeutic effect.
- •Habitual use of psychotropic or narcotic analgesics for ≥1 week within 8 weeks prior to screening.
- •Participated in other intervention studies on the past 6 months to screening
- •Participants with congenital musculoskeletal deformity.
结局指标
主要结局
Anatomical improvement
时间窗: one month
subchondral bone improvement following the application of Phonophoresis using chitosan-nanoparticles gel, ECSW therapy and assessed by Artificial intelligence based texture analysis algorithm
次要结局
- level of knee pain(one month)
研究者
Athar Tarek Mohamed Fahmy Azab
principle Investigators
Cairo University