EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME (Laser)
Primary Purpose
Physical Therapy, Orthopedic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High Intensity Laser Therapy Group
Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Ultrasound and Interferential Current Stimulation Group
Sponsored by
About this trial
This is an interventional treatment trial for Physical Therapy focused on measuring Patellofemoral pain, High intensity laser therapy
Eligibility Criteria
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
Sites / Locations
- Ozge Ozlu
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
High Intensity Laser Therapy Group
Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Ultrasound and Interferential Current Stimulation Group
Arm Description
Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions
Patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions
Patients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions
Outcomes
Primary Outcome Measures
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
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
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).
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.
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.
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05075525
First Posted
September 29, 2021
Last Updated
October 11, 2021
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05075525
Brief Title
EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME
Acronym
Laser
Official Title
EFFECT OF HIGH INTENSITY LASER THERAPY ON PAIN AND LOWER EXTREMITY FUNCTION IN PATELLOFEMORAL PAIN SYNDROME
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Anticipated)
Study Completion Date
June 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy, Orthopedic Disorder
Keywords
Patellofemoral pain, High intensity laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are blinded to allocation and outcomes measures.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Laser Therapy Group
Arm Type
Experimental
Arm Description
Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions
Arm Title
Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Arm Type
Experimental
Arm Description
Patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions
Arm Title
Ultrasound and Interferential Current Stimulation Group
Arm Type
Experimental
Arm Description
Patients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions
Intervention Type
Other
Intervention Name(s)
High Intensity Laser Therapy Group
Intervention Description
High Intensity Laser Therapy (HILT) and exercises will be used.
Intervention Type
Other
Intervention Name(s)
Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Intervention Description
Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
Intervention Type
Other
Intervention Name(s)
Ultrasound and Interferential Current Stimulation Group
Intervention Description
Ultrasound (US) ,interferential current stimulation and exercise will be used.
Primary Outcome Measure Information:
Title
Pain status
Description
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
Time Frame
5 minutes
Title
Range of motion assesment
Description
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
Time Frame
10minutes
Title
Functionality
Description
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).
Time Frame
5 minutes
Title
Muscle stength assesment
Description
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.
Time Frame
10 minutes
Title
Pain threshold assessment
Description
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.
Time Frame
10 minutes
Title
Severity and function of patellofemoral pain
Description
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).
Time Frame
5 minutes
Title
Function of lower extremity
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OZGE OZLU
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozge Ozlu
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34820
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30178432
Citation
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.
Results Reference
result
Learn more about this trial
EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME
We'll reach out to this number within 24 hrs