EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME (Laser)

EFFECT OF HIGH INTENSITY LASER THERAPY ON PAIN AND LOWER EXTREMITY FUNCTION IN PATELLOFEMORAL PAIN SYNDROME

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Orthopedic Disorder; Physical Therapy
• Intervention / Treatment: Other: High Intensity Laser Therapy Group; Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group; Other: Ultrasound and Interferential Current Stimulation Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34820
      • Ozge Ozlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Laser Therapy Group; Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions	Other: High Intensity Laser Therapy Group; High Intensity Laser Therapy (HILT) and exercises will be used.
Experimental: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group; Patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions	Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group; Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
Experimental: Ultrasound and Interferential Current Stimulation Group; Patients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions	Other: Ultrasound and Interferential Current Stimulation Group; Ultrasound (US) ,interferential current stimulation and exercise will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: OZGE OZLU, Medipol University

Publications and helpful links

General Publications

• 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-week follow up. Lasers Med Sci. 2019 Apr;34(3):505-516. doi: 10.1007/s10103-018-2624-4. Epub 2018 Sep 3.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Anticipated): March 10, 2022
• Study Completion (Anticipated): June 10, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: High intensity laser therapy; Patellofemoral pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID Numbers: ozgeozlu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No