Physical TherapyLaserNCT05075525
EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME
A study testing High Intensity Laser Therapy Group, Ultrasound and Transcutaneous Electrical Nerve Stimulation Group and Ultrasound and Interferential Current Stimulation Group in people with Physical Therapy and Orthopedic Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Physical Therapy, Orthopedic Disorder
- What is being tested?
- High Intensity Laser Therapy Group, Ultrasound and Transcutaneous Electrical Nerve Stimulation Group and Ultrasound and Interferential Current Stimulation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Therapy, Orthopedic Disorder
- Being tested
- High Intensity Laser Therapy Group, Ultrasound and Transcutaneous Electrical Nerve Stimulation Group, Ultrasound and Interferential Current Stimulation Group
- Keywords
- Patellofemoral pain, High intensity laser therapy
- Medical subject headings
- Musculoskeletal Diseases, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser Therapy GroupOther
High Intensity Laser Therapy (HILT) and exercises will be used.
Ultrasound and Transcutaneous Electrical Nerve Stimulation GroupOther
Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
Ultrasound and Interferential Current Stimulation GroupOther
Ultrasound (US) ,interferential current stimulation and exercise will be used.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Laser Therapy Group | Experimental | Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions Receives: Other: High Intensity Laser Therapy Group |
| Ultrasound and Transcutaneous Electrical Nerve Stimulation Group | Experimental | Patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions Receives: Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group |
| Ultrasound and Interferential Current Stimulation Group | Experimental | Patients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions Receives: Other: Ultrasound and Interferential Current Stimulation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start10 Sep 2021
- Primary completion10 Mar 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ozluozge, Istanbul Medipol University Hospital
- Investigators
- OZGE OZLU, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075525
- Sponsor's protocol ID
- ozgeozlu
- Acronym
- Laser
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.
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.
PubMed 30178432
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF HIGH INTENSITY LASER THERAPY ON PAIN AND LOWER EXTREMITY FUNCTION IN PATELLOFEMORAL PAIN SYNDROME
- ClinicalTrials.gov ID
- NCT05075525
- Acronym / sponsor ID
- Laser / ozgeozlu
- Conditions
- Physical Therapy, Orthopedic Disorder
- Keywords
- Patellofemoral pain, High intensity laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Mar 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Laser Therapy Group | Experimental | Other: High Intensity Laser Therapy GroupPatients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions |
| Ultrasound and Transcutaneous Electrical Nerve Stimulation Group | Experimental | Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation GroupPatients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions |
| Ultrasound and Interferential Current Stimulation Group | Experimental | Other: Ultrasound and Interferential Current Stimulation GroupPatients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Laser Therapy GroupHigh Intensity Laser Therapy (HILT) and exercises will be used. | Other | High Intensity Laser Therapy Group |
| Ultrasound and Transcutaneous Electrical Nerve Stimulation GroupTranscutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied. | Other | Ultrasound and Transcutaneous Electrical Nerve Stimulation Group |
| Ultrasound and Interferential Current Stimulation GroupUltrasound (US) ,interferential current stimulation and exercise will be used. | Other | Ultrasound and Interferential Current Stimulation Group |
Primary outcome
Pain status
Time frame: 5 minutes
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
Time frame: 10minutes
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
Time frame: 5 minutes
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
Time frame: 10 minutes
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
Time frame: 10 minutes
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
Time frame: 5 minutes
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
Time frame: 10 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 30178432Nazari 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.
- Individual participant dataSharing planned: No. When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OZGE OZLU principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Laser Therapy Group, Ultrasound and Transcutaneous Electrical Nerve Stimulation Group and Ultrasound and Interferential Current Stimulation Group in people with Physical Therapy and Orthopedic Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain status (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05075525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.