Effect of Ultrasound With Simultaneous Hyaluronate Injection on Risk of Fall in Geriatric Women With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Berg balance scale
研究概览
简要总结
For many years' physiotherapists have been using ultrasound in treatment of knee osteoarthritis especially in geriatrics (people aged above 65 years) for its known therapeutic effect in relieving pain and improving knee function. Hyaluronan is used to treat osteoarthritis of the knee. Such treatments, called viscosupplementation, are administered as a course of injections into the knee joint, and are believed to supplement the viscosity of the joint fluid, thereby lubricating the joint, cushioning the joint, and producing an analgesic effect. Studies reveals the risk for falls increases with additional symptomatic OA lower limb joints and confirms in addition to gender factor; including female sex.
详细描述
It is hypothesized that physical therapy by ultrasound might add some extra benefit on risk of fall when applied after intra-articular hyaluronate of Knee OA in female geriatrics. So, forty female geriatrics with ages ranged from 65 to 75 years, randomly will be selected from Ahmed Maher Teaching Hospital, Kasr el einy hospital, Charity clinic and Outpatient clinic of Badr university, referred to physical therapy by an orthopedic surgeon. All will be diagnosed as chronic OA of one or both knees where conventional therapeutic measures failed. They will be assigned to begin HA intra-articular knee injection by the orthopedic surgeon once weekly for 3 weeks. These patients will be randomly divided into 2 groups equal in number, group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound, while group (2) served as the control group receiving only HA intra-articular knee injection.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients' ages above 65 years.
- •Patients diagnosed as chronic osteoarthritis of more than 5 years.
- •The OA diagnosed as grade (III to V)
- •Patients failed with conventional treatment.
- •All patients followed up with the same orthopedic surgeon, and they took the same type of HA intra-articular injection (HA of High MW 3000 kDa).
- •All patients were medically stable and do not suffer from any other diseases which may affect the trial results.
- •All patients were not treated with analgesics or any medication which may cause misleading results.
- •None of the patients received intra-articular hyaluronic acid injection for 1 year or intra-articular corticosteroid injection within the last 3 months.
- •All patients didn't take or oral glucosamine or chondroitin supplements or stopped these drugs 2-3 months before participating in this study.
- •Every patient signed a consent form.
排除标准
- •Young individuals (their age is below 65 years old).
- •Mild degree of OA (grade I & II).
- •Patients who had undergone knee arthroscopy, or any knee surgery.
- •Patients with OA secondary to trauma.
- •Patients with metal implants.
- •Patients with CNS dysfunction.
研究组 & 干预措施
Injection group
Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
干预措施: Therapeutic Ultrasonic (Device)
Injection group
Group (1) the study group, they will receive HA intra-articular injection in addition to 12 sessions of therapeutic ultrasound.
干预措施: Hyaluronan intra-articular injection (Drug)
Ultrasound group
Group (2) served as the control group, will receive only HA intra-articular knee injection.
干预措施: Hyaluronan intra-articular injection (Drug)
结局指标
主要结局
Berg balance scale
时间窗: At the beginning of study, we assess balance by Berg balance scale in patients in both groups then after one month to assess progression in balance in both groups.
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
6 min walk test
时间窗: At the beginning of study, we assess balance by 6 min walk test in patients in both groups then after one month to assess progression in balance in both groups.
The 6MWT required a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measured the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
ROM
时间窗: At the beginning of study, we measure range of motion in patients in both groups then after one month to assess progression of range of motion in both groups.
Range of motion by using OB Goniometer "Myrin"
次要结局
未报告次要终点
研究者
Hend Reda Sakr
Lecturer of Physical Therapy for Woman's Health
Badr University