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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05075525
Other study ID # ozgeozlu
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 10, 2021
Est. completion date June 10, 2022

Study information

Verified date October 2021
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effectiveness of high-intensity laser therapy on pain and lower extremity function in the treatment of patellofemoral pain syndrome.


Description:

Participants between the ages of 25-45 who were diagnosed with Unilateral patellofemoral pain syndrome by the doctor will be included in the study. Also positive Clarke's test and patellar compression tests will be determined as inclusion criteria. The 45 participants will be randomly divided into three groups. Both groups will receive 2 weeks (5 sessions per week) of therapy. First group patients underwent High Intensity Laser Therapy (HILT) and exercises. Second group patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions. Also In the third group patients will be treated with ultrasound (US),interferential current stimulation and exercise. All groups receive the same exercise exercise protocol including muscle strengthening and flexibility training for 12 weeks. The outcomes will be pain intensity measured by visual analog scale (VAS) , knee flexion range of motion (FROM), timed up and go test (TUG),muscle strength measured with handheld dynamometer, Pressure Pain Threshold with an algometry and functionality of knee measured by the Lower extremity functional scale and Kujala patellofemoral questionnaire. Statistical analyzes will be performed to compare amounts at baseline, immediately after treatment, and after 12 weeks.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date June 10, 2022
Est. primary completion date March 10, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Unilateral patellofemoral pain syndrome diagnosed by a doctor - 25-45 years old - pain from prolonged sitting, climbing and descending stairs, running,knee bend more than 3 months - positive patellar compression and clarke's tests. Exclusion Criteria: - Previous knee pain, trauma, surgery and other joint diseases, - Knee ligament, bursa, meniscus and synovial fold injury or dysfunction - Osteoarthritis in the knee joint, - Neurological problems that may affect walking - Pregnancy - No chronic disease - Malignancy, - Presence of infection

Study Design


Intervention

Other:
High Intensity Laser Therapy Group
High Intensity Laser Therapy (HILT) and exercises will be used.
Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
Ultrasound and Interferential Current Stimulation Group
Ultrasound (US) ,interferential current stimulation and exercise will be used.

Locations

Country Name City State
Turkey Ozge Ozlu Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Nazari A, Moezy A, Nejati P, Mazaherinezhad A. Efficacy of high-intensity laser therapy in comparison with conventional physiotherapy and exercise therapy on pain and function of patients with knee osteoarthritis: a randomized controlled trial with 12-wee — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain status Pain intensity was evaluated with visual analog scale (VAS) in two conditions during activity and resting time. This method, which is developed to determine the intensity of pain to indicate by numbers. It begins with the absence of pain (0) on numerical scale and ends the level of unbearable pain 5 minutes
Primary Range of motion assesment Universal goniometer will used to measure the joint position and joint range of motion measurements based on Kendall and American Association of Orthopedic Surgeons. The participant will in the sitting position and asked to perform active cervical region flexion, extension, right and left rotation, right and left lateral flexion of the neck movements and performed degrees will recorded 10minutes
Primary Functionality The patients will asked to start from a sitting position in a chair, to get up at the command given, to walk the predetermined distance of 3 meters as fast as they could, and to return to their seats. The time from the time they got up from the chair and sat down again will recorded with a stopwatch. Measurements will be repeated 3 times and the average will be recorded in seconds (sec). 5 minutes
Primary Muscle stength assesment A myometer will be used to measure the strength of the hamstring and quadriceps muscle groups of all participants. Myometer is an evaluation method that objectively evaluates muscle strength and gives more sensitive results than manual muscle testing. 10 minutes
Primary Pain threshold assessment Pressure pain threshold measurement will be measured with an algometer device. Algometers are a device that can be used to define pressure and pressure pain threshold. 10 minutes
Primary Severity and function of patellofemoral pain It will be evaluated with the 'Kujala patellofemoral score' system. These scoring system values range from 100 (normal, pain-free, fully functional knee) to 0 (severe knee pain and dysfunction). 5 minutes
Primary Function of lower extremity A lower extremity function test will be used to measure lower extremity functionality. It is a test used to measure the functional status of the lower extremities. 10 minutes
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