Influence of Honey Phonophoresis on Cartilage Thickness in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- cartilage thickness
研究概览
简要总结
Osteoarthritis (OA) is a progressive chronic disease with the loss of articular cartilage. It is now well recognized that the progression of the disease involves erosion of the cartilage, osteochondral inflammatory damage, and bone distortion. Many recent medical procedures provide treatment through improving symptoms through tissue regeneration and restoring homeostasis to local cells. Unlike bone, articular cartilage is rather recalcitrant to regenerate. Honey is a natural material contain 200 distinct chemical compounds in honey including a wide range of phenolic compounds that have antioxidant, bacteriostatic, antimicrobial, and anti-inflammatory properties. Honey was found to increase the printability and chondrogenic potential of a naturally derived bioink are the main formulations used as hydrogel for Articular Cartilage (AC) regeneration due to their similarity to chondral tissue in terms of morphological and mechanical properties. Design: Double blinded, Randomized control trial. Methods: 50 osteoarthritic patients will be evaluated to be allocated after they match the inclusion criteria then randomized to two groups, group A for Phonophoresis using Honey as coupling media with conventional physical therapy program, group B for ultrasound with regular gel as a coupling media with conventional physical therapy. Outcome measures: the primary outcome measure will be the thickness of the cartilage will be measured using diagnostic ultrasound, the secondary outcome measure will be knee pain measured by the visual analog scale (VAS) and Western Ontario and McMaster Universities OA Index (WOMAC) pain subscale, also functional mobility which will be measured using the stiffness and physical function subscales of the total WOMAC. All will be measured 1 day before starting the procedures and after 4 weeks of the intervention 3sessions/week.
详细描述
This study will be conducted on patients with bilateral medial tibiofemoral OA, Patients who will be diagnosed and referred by a physician according to the following criteria: bilateral mild-to-moderate medial tibiofemoral OA based on the American College of Rheumatology criteria, and a radiological image (Kellgren-Lawrence Grade II-III). All the patients will be informed about the study and consented to participate in it.
Patients will be excluded from the study if they have rheumatologic conditions such as rheumatoid arthritis, severe knee OA, thrombosis of the lower limbs, physiotherapy treatment of the knee in the previous 6 months, a history of injections in the knee joint during the last 6 months, balance disorders, neuropathy or sensory disorders, skin damage around the knee, previous surgery on the knee joint, or a previous fracture of the lower extremity with knee joint involvement. Patients will be also excluded if they have any contraindications or precautions for the use of ultrasound (e.g., infection, heart problems, pacemaker, metal implants, open epiphysis, pregnancy, thrombophlebitis, or impaired sensation).
Fifty patients with bilateral knee OA whose ages range from 40 to 65 years and body mass indexes between 25 to 35 kg/m2, who will meet the eligibility criteria and will be randomized into two treatment groups using computer-generated numbers in sealed envelopes. The patients will be blinded to the group allocation. Group A will receive phonophoresis with honey and conventional physical therapy treatment in the form of transcutaneous electrical nerve stimulation (TENS) current and exercise (study group). The parameters of the application of phonophoresis will be the continuous modality, 1 MHz frequency, intensity of 1 or 1.5 W/cm2, and an application time of 10 minutes. Group B will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group).
Evaluation procedure:
The evaluation process will be conducted within the Department of physical therapy, and Department of radiology of Jazan University, Jazan region, KSA.
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
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bilateral mild-to-moderate medial tibiofemoral Osteoarthritis
排除标准
- •rheumatologic conditions such as:
- •rheumatoid arthritis,
- •severe knee OA,
- •thrombosis of the lower limbs,
- •patients who had physiotherapy treatment of the knee in the previous 6 months,
- •a history of injections in the knee joint during the last 6 months,
- •balance disorders,
- •neuropathy or sensory disorders,
- •skin damage around the knee,
- •previous surgery on the knee joint, or a previous fracture of the lower extremity with knee joint involvement.
- •Patients will be also excluded if they have any contraindications or precautions for the use of ultrasound (e.g., infection, heart problems, pacemaker, metal implants, open epiphysis, pregnancy, thrombophlebitis, or impaired sensation)
研究组 & 干预措施
Control Group
will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group)
干预措施: Ultrasound (Device)
Honey Group
will receive phonophoresis with honey and conventional physical therapy treatment in the form of transcutaneous electrical nerve stimulation (TENS) current and exercise . The parameters of the application of phonophoresis will be the continuous modality, 1 MHz frequency, intensity of 1 or 1.5 W/cm2, and an application time of 10 minutes
干预措施: Phonophoresis (Device)
Honey Group
will receive phonophoresis with honey and conventional physical therapy treatment in the form of transcutaneous electrical nerve stimulation (TENS) current and exercise . The parameters of the application of phonophoresis will be the continuous modality, 1 MHz frequency, intensity of 1 or 1.5 W/cm2, and an application time of 10 minutes
干预措施: conventional physiotherapy (Procedure)
Control Group
will receive ultrasound therapy with gel media and the same conventional physical therapy treatment (control group)
干预措施: conventional physiotherapy (Procedure)
结局指标
主要结局
cartilage thickness
时间窗: 4 weeks
knee joint cartilage thickness
次要结局
- Pain severity(4 weeks)
- Functional mobility(4 weeks)
研究者
Mohamed Moustafa Mohamed Ahmed
Assistant professor
University of Jazan