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临床试验/NCT04945759
NCT04945759已完成不适用

Comparison of the Efficacy of Russian and Aussie (Australian) Currents With Isokinetic Exercise in Individuals With Patellofemoral Pain Syndrome: A Randomized Controlled Study.

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Abduction/Adduction Measurement of Isokinetic Hip Strength:

研究概览

简要总结

Summary

Patellofemoral pain syndrome (PFPS) is defined as common anterior knee pain that occurs during non-traumatic activities such as squatting, running, climbing and climbing stairs.The effectiveness of electrotherapy in increasing muscle strength and endurance in PFPS has generally been investigated using low frequency electrical stimulation methods, and studies on the effectiveness of medium frequency burst module alternating currents are few in number. Since there are no studies in the literature comparing the efficacy of Russian and Aussie currents from mid-frequency burst modulated alternating currents with isokinetic exercise in patients with PFPS, the aim of this study is to examine the pain, functionality, daily living activities of Russian and Aussie currents with knee and hip Isokinetic Exercise (IE) in patients with PFPS and its effect on quality of life.

This study, which has a randomized controlled and single-blind design, is planned to be conducted on at least 60 volunteers who meet the inclusion criteria of patients with PFPS who came to Necmettin Erbakan University Sports Medicine Clinic. Participants' physical and socio-demographic information will be recorded; pain intensity Patellofemoral Syndrome Pain Severity Scale; functionality Kujala Patellofemoral Score, Timed Up and Go Test and stair climb test; activity levels Tegner Activity Level score; functional impairment Lysholm Knee Scoring Scale; activities of daily living Knee Test for Activities of Daily Living; quality of life Short Form SF-36; passive and painless active range of motion goniometer; Isokinetic forces of quadriceps, hamstring and gluteus medius muscles CYBEX (2009) device; The Q angle will be evaluated using a goniometer.

Participants will be randomized into four groups; The first group will receive knee and hip IE treatment for three weeks for 15 sessions, the second group will receive Aussie Current in addition to IE, the third group will receive Russian Current in addition to IE, and the fourth group will receive placebo electrical stimulation in addition to IE. Evaluations will be made at the beginning, immediately after the first treatment, at the end of three weeks of treatment and one month after the end of the treatment, in total four times. It is thought that the results of the study will be an important source of information about the place of medium frequency burst modulated alternating currents in physiotherapy programs of patients with PFPS.

详细描述

Patellofemoral pain syndrome (PFPS) is the most common pain syndrome of the knee arising around the patella due to knee overload during flexion and extension. It is defined as common anterior knee pain that occurs during non-traumatic activities such as squatting, running, climbing and climbing stairs. Risk factors for PFPS include dynamic valgus, female gender, foot abnormalities, overuse and sudden increase in physical activity, patellar instability, and quadriceps weakness .

In order to reveal effective treatment in PFPS, primary reasons that may cause the syndrome should be emphasized. The causes of PFPS are multifactorial and it is difficult to determine the actual effects that may cause the disease.However, when PFPS is considered from a biomechanical point of view, there is a strong relationship between the knee joint and the ankle and hip joint.

While rest, ice and analgesics are used in the early period in PFPS treatment, non-steroidal anti-inflammatory drugs (NSAIDs), patellar banding, patellofemoral knee and foot orthoses, biofeedback, running gait retraining, blood circulation restriction therapy are used in the treatment of PFPS in the early period. Dry needling, manual therapy, biophysical agents, patient education and combined therapies are used. In the treatment of patellofemoral pain syndrome, the treatment method that has been focused in recent years is conservative treatment. Among these, physiotherapy is the cornerstone of treatment.

Although the common treatment is quadriceps strengthening, in recent years, therapies have been emphasized to strengthen the gluteus medius and increase the stability of the core. At the 5th International Meeting of the Patellofemoral Pain Research Center (2018, Australia), combined strengthening programs with strengthening of the quadriceps and hip muscles were recommended in the treatment of PFPS.

Although a versatile treatment is generally performed, the rate of PFAS recurrence is 91%. Due to the high recurrence rate, more effective treatment options should be revealed. When the literature is reviewed, it has been reported that in PFPS cases, there is an increase in muscle strength and endurance with the isokinetic exercise (IE) program, and this provides dynamic knee stabilization.The IE program is mostly in the direction of knee flexion / extension, and it has been found that there are very few applications of IE programs in the direction of hip (gluteus medius) abduction / adduction, internal and external rotation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being in the age range of 18-55,
  • •Being able to read and write in Turkish,
  • •Having pain for more than a month,
  • •Having anterior knee pain without trauma,
  • •To have a pain intensity of three points and / or above according to the Visual Analogue Scale (VAS) in the peri or retropatellar region in the previous week.

排除标准

  • •Meniscus, cross and collateral ligament, iliotibial band lesion, Having pes anserin tendinitis, Osgood-Schlatter syndrome,
  • •Sinding-Larsen-Johansson Syndrome, previous patellar dislocation and previous knee surgery, having received knee injection treatment at least three months ago,
  • •Using Nonsteroidal Anti-inflammatory and Cortisone drugs frequently once a week or more,
  • •Trauma history and neurological disease,
  • •Having a patellar fracture, osteoarthritis or other intra-articular knee pathology,
  • •Having pain and knee effusion reflected from the hip and lumbar region (
  • •Those with contraindicated conditions for electrical stimulation (biomedical device implant, pregnant women, neuropathy, muscle abnormalities or hypersensitivity, malignancy, hemorrhagic area, skin damage, active infection in the area where the electrodes are placed) (3,59).
  • •Having had previous electrical stimulation therapy

研究组 & 干预措施

Isokinetic Exercise (İE) Group:

Experimental

Isokinetic Exercise (IE) Group:

(Knee Joint Flexion / Extension, Hip Joint Internal / External Rotation and Abduction / Adduction Strengthening Program)

Patients will be seated on the isokinetic Cybex-Humac Norm device in a 90° upright sitting position. It will be fixed to the seat with torso, pelvis and thigh straps. During this training, patients will be told that the dynamometer arm will bring the knee from extension to flexion. During this exercise, the patient will be advised to resist the dynamometer as much as possible while moving the knee in flexion/extension, internal/external rotation, and abduction/adduction with the dynamometer.

干预措施: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon (Device)

Isokinetic Exercise + Aussie Current (IE+AC)Group:

Active Comparator

Aussie Current and Isokinetic Exercise program will be applied to the patients. The distal electrode is placed on the anterior part of the thigh and superior to the patella. The proximal electrode will be placed on the thigh. One electrode will be placed between the anterior superior and posterior superior iliac spine of the PFPS(Patellofemoral Pain Syndrome) side and the other electrode will be placed in a triangle on the greater trochanter of the femur in the gluteus medius muscle. By contacting the Turkish authorities of the BTL 4825SPREMIUM device, the current was adjusted in the Aussie Current 1 kHz frequency, 400 ms phase time, 50 hz burst frequency, 4 ms duration device. This new burst modality medium frequency alternating current will be applied to the patient for 20 minutes.

干预措施: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon (Device)

Isokinetic Exercise + Russian Current (IE+RC) Group:

Active Comparator

Isokinetic Exercise program will be applied to the patients. Similarly, as with the Aussie Current, the Russian current will be applied to the vastus lateralis-medialis and gluteus medius muscles.

Russian current will be set as 2500 Hz sinusoidal current, 200 ms phase time, 50 hz burst frequency, 50% duty cycle, 10 ms duration.

The patient will be treated for 20 minutes.

干预措施: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon (Device)

Isokinetic Exercise + placebo Electrical Stimulation (IE+PES) Group:

Placebo Comparator

Isokinetic Exercise program will be applied to the patients. The appropriate modalities will be set on the electrical stimulation device, but the device will not operate. It will be applied for 20 minutes.

干预措施: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon (Device)

结局指标

主要结局

Abduction/Adduction Measurement of Isokinetic Hip Strength:

时间窗: 2 minute

The cases will be placed on the Cybex Humac Norm System. The non-tested knee and hip (table side) will be fixed with a tape. The pelvis will be fixed on the CYBEX system with a pelvic band. The axis of the extremity to be tested will be aligned 2 centimeters medial and below the anterior superior iliac crest. The lever arm of the dynamometer will be fastened just above the knee with the help of a belt. Gravity correction will be provided with extreme weight during the test. The test will be started in the full abduction position. In addition, hip abduction/adduction will be evaluated at 30°/60° second rates. Four submaximal repetitions at each speed and a fifth test will be performed. Peak torque, abduction/adduction force, abduction/adduction torque ratio will be calculated.

A)Measurement of Isokinetic Muscle Strength of Knee Flexion / Extension:

时间窗: 8 minute

Measurement of Isokinetic Muscle Strength: Before the test, patients will be warmed up for 10 minutes with an elliptical bicycle (the brand of the device). Isokinetic muscle strength of the quadriceps and Hamstring groups (at 60°/120°/180 °/second velocity) will be measured using Humac Norm System. To familiarize patients unfamiliar with the test, 3 sub-maximal contractions and 1 maximal contraction will be performed for each muscle group and at each speed. The affected extremity will be evaluated for testing. After the test, the flexor and extensor peak torques at 60°/120°/180° second angular velocities and the work done and hamstring/quadriceps (H/Q) ratios will be calculated in the computer environment. Peak torque values will be recorded.

Patellofemoral Syndrome Pain Severity Scale

时间窗: 3 minute

It is a scale consisting of 10 parameters that evaluates the pain in the activities of the individual during the last week with VAS. These activities include climbing stairs, crouching on the ground, walking, jogging, fast jogging, participation in a sport, sitting with bent knees, kneeling, resting and sleeping, resting after activity. Individuals will also mark activities they did not do in the last week as "I did not do". The maximum score is 100 and the evaluation results will be recorded in%.

Interna /External Rotation Measurement of Isokinetic Hip Strength:

时间窗: 5 minute

In addition, taking into account the points in the evaluation of hip flexion/extension using the Cybex Humac Norm System, the patient will be positioned in the sitting position with the knee and hip at 90° flexion, and the trunk at 30° extension. The hip on the tested side will be fixed over the thigh, and the leg area will be fixed with a band just above the ankle. The dynamometer axis will be aligned with the long axis of the patella. The test will begin from maximum active external rotation to internal rotation. Hip medial and lateral rotation will be applied at speeds of 30°/60° seconds. 30 seconds of rest will be given after each speed. The test will be performed after four submaximal repetitions at each rate. Peak torque, internal/external force, internal/external torque ratio will be calculated.

Kujala Patellofemoral Score

时间窗: 3 minute

The Turkish validity and reliability study was conducted by Kuru et al. KPS includes questions about patellar alignment and the position of the patella, and consists of 13 items that evaluate subjective responses to specific activities and symptoms thought to be associated with PFAS. It is scored from a minimum of 0 to a maximum of 100 points. A variation of 8-10 points constitutes the minimum significant difference in clinical practice. Lower scores indicate more pain and disability, while higher scores indicate fewer disabilities. In the guideline published by the American Physical Therapy Association, Orthopedic Physical Therapy Academy, it was stated that the use of KPS form in PFAS patients reveals high quality data.

Knee Test for Daily Living

时间窗: 3 minute

Symptoms and functional limitations of individuals in daily living activities will be evaluated with the Knee Test for Daily Living Activities (KOS-ADLS), which is a valid and reliable questionnaire that has been made in Turkish. The test includes six questions about symptoms: pain, stiffness, swelling, relaxation / flexion of the knee, weakness, and limping. It also includes eight questions about functional limitations, including walking, climbing stairs, descending stairs, standing, kneeling, crouching, sitting with bent knees, and getting up from a chair. The test is scored between 0-5. The patient's scores from each question are added up and the total score is divided by 70 and multiplied by 100.

次要结局

  • Q Angle Measurement:(3 minute)
  • Lysholm Knee Scoring Scale(2 minute)
  • Timed Get Up and Go Test(2 minute)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

MUSA ÇANKAYA MSc.PT

Master of Science (Lecturer)

Muğla Sıtkı Koçman University

研究点 (1)

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