Comparison of the Efficacy of Russian,Aussie Currents With Isokinetic Exercise Patellofemoral Pain Syndrome

NCT04945759 | Completed DMC

• 1 other identifier: 11.02.2020 V;1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral Pain Syndrome; Aussie Current

Outcome Measures

Primary Outcomes (6)

• Patellofemoral Syndrome Pain Severity Scale

  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%.

  3 minute

• Kujala Patellofemoral Score

  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.

  3 minute

• Knee Test for Daily Living

  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.

  3 minute

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

  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.

  8 minute

• Interna /External Rotation Measurement of Isokinetic Hip Strength:

  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.

  5 minute

• Abduction/Adduction Measurement of Isokinetic Hip Strength:

  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.

  2 minute

Secondary Outcomes (3)

• Timed Get Up and Go Test

  2 minute

• Lysholm Knee Scoring Scale

  2 minute

• Q Angle Measurement:

  3 minute

Study Arms (4)

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.

Device: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon

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.

Device: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon

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.

Device: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon

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.

Device: Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon

Interventions

Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon DEVICE

Evaluation and treatment will be done with the Cybex humac device.

Isokinetic Exercise (İE) Group:; Isokinetic Exercise + Aussie Current (IE+AC)Group:; Isokinetic Exercise + Russian Current (IE+RC) Group:; Isokinetic Exercise + placebo Electrical Stimulation (IE+PES) Group:

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Musa Çankaya

Konya, 0506295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• MUSA ÇANKAYA, Msc

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• İLKİM ÇITAK KARAKAYA, Professor

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• PELİN MELDA YARGIÇ, PhD

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science (Lecturer)

Model Details: Posttest and control grouped randomized controlled clinical trial.

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 30, 2021
• Study Start: August 28, 2021
• Primary Completion: September 20, 2022
• Study Completion: December 20, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: It will be published in a peer-reviewed journal within 6 months after the study is completed.
• Access Criteria: The protocol of the research will be published in an international congress as soon as possible. Broadcast link will be shared.

Locations

TU (1)