Mechanical Knee Decompression With and Without Heating: Impact on Pain, Function, and Range of Motion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- active knee range of motion
研究概览
简要总结
a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.
详细描述
Osteoarthritis (OA) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. The knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of OA worldwide. Subjects having KOA demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (ROM), and declined functional status.
Except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. Medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability.
Interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. However, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This study will be double-blinded consequently neither the assessor nor the data analyzer will be aware of the allocation sequence. Each participant will be coded using special numbers that refer to the correct allocation. The interpretation of these code numbers will be kept with the senior author who will not be involved in the treatment or assessment. The therapist will only be allowed to get the code number interpretation after the end of the allocation process and at the beginning of the study. In this study, the participants and the therapist will be blind.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes
- •age between 45 to 60 years.
- •Normal and or overweight categories of BMI 19-30 kg/m2
- •Unilateral (grade 2 and 3) knee OA according to the Kellgren-Lawrence radiological rating scale
排除标准
- •lower limb deformities as genu varum, valgus, flat foot
- •leg length discrepancy
- •previous trauma and or surgery to the knee joint
- •Bone disease
- •Inability to refrain from analgesic/anti-inflammatory medications for 6 weeks
研究组 & 干预措施
Standard physical therapy program
All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks
干预措施: standard physical therapy (Other)
knee Decompression
The ACUTRAC AT270 Traction System device will be used for traction. The patient will assume the supine position with the hip of the treated limb in semi-flexion and the ipsilateral knee in 25-30º flexion. 15 minutes of continuous mechanical traction using 20% of the patient's weight will be used. The session will be 15 minutes, once a day, three-times a week for 6 weeks.
This group will receive decompression and standard physical therapy.
干预措施: standard physical therapy (Other)
knee Decompression
The ACUTRAC AT270 Traction System device will be used for traction. The patient will assume the supine position with the hip of the treated limb in semi-flexion and the ipsilateral knee in 25-30º flexion. 15 minutes of continuous mechanical traction using 20% of the patient's weight will be used. The session will be 15 minutes, once a day, three-times a week for 6 weeks.
This group will receive decompression and standard physical therapy.
干预措施: knee Decompression (Other)
Decompression plus heating
this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session
干预措施: standard physical therapy (Other)
Decompression plus heating
this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session
干预措施: knee Decompression (Other)
Decompression plus heating
this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session
干预措施: hot pack (Other)
结局指标
主要结局
active knee range of motion
时间窗: after the end of the treatment (after 6 weeks)
this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.
function
时间窗: after the end of the treatment (after 6 weeks)
It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability
pain intensity
时间窗: after the end of the treatment (after 6 weeks)
Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.
pain intensity
时间窗: at base line
Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line.
active knee range of motion
时间窗: at baseline
this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated.
function
时间窗: at baseline
It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability
次要结局
未报告次要终点
研究者
Hisham Mohamed Hussein
principal investigator
University of Hail