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
- 2
- 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.
研究组 & 干预措施
Group A: Ultrasound therapy combined with Chitosan nanoparticles gel and Exercises Program
In this group will receive ultrasound therapy coupled with chitosan-nanoparticles gel with an exercises program. The US protocol which will consist of pulsed ultrasound waves. The parameters that will be selected consists of; frequency of 1 MHz, 1 W/cm2 power delivered at an intensity of an intensity of 2.5W/ cm2 and with duty cycle of 25% and will be applied with a 5-cm diameter applicator.
The area of treatment will be cleaned to permit an effective skin applicator coupling. Each patient will be placed in a supine position for the application of ultrasound. A suitable palpation to locate the discomfort source and some passive motions to identify a range of motion restriction will be completed prior to the ultrasound application.
Ultrasound will be applied to the medial and lateral aspects of the knee in circular motions, with the probe at right angles to ensure maximum absorption of energy. Each session will last for 5 minutes.
干预措施: Ultrasound therapy combined with Chitosan nanoparticles gel (Combination Product)
Group B: Application of Extracorporeal Shockwave and Exercises Program:
This group will receive ESWT with an exercises program. Subjects will receive 5 sessions, one week apart. Before the treatment, subjects will be placed in supine to expose and prepare the treated area with the knee flexed at angle of 90° and the hip is abducted and externally rotated. The impulses will be applied on the subchondral bone at the medial and lateral tibia condyle at 2.0 cm below the joint line in anteroposterior view and 2.0 cm from the medial skin edge in lateral view. The treatment application will be as follows: 2000 impulses will be administered at (EFD) with an energy flux density ranging from 0.22-0.43 mJ / mm2 at 8 Hz. In which 0.22 mJ/mm²: likely corresponds to around 1.5-3 bars, while 0.43 mJ/mm² likely corresponds to around 3-5 bars. The probe was chosen effective treatment depth (5-20-mm focal depth), semi-movable technique of the shockwave applicator and 5 minutes duration.
干预措施: Ultrasound therapy combined with Chitosan nanoparticles gel (Combination Product)
Group C: Exercises Program
Patients in this group will receive only an exercises program for 3 times weekly for 4 weeks. This program includes:
(1) Warming-up (5 min); (2) strengthening exercises for the lower limbs: 3 sets of 15 repetitions: flexion SLR, abduction SLR, and extension SLR, standing knee flexion, quadriceps isometrics, 10 repetitions of 5 s, 0° and 30°; (3) aerobic exercise on a stationary bike (20 min), (4) and stretching (5 min) with a weekend break.
All patients in the three groups (A, B and C) will receive the same exercise program.
干预措施: Ultrasound therapy combined with Chitosan nanoparticles gel (Combination Product)
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