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Status unknownNCT05075525LaserUpdated Oct 12, 2021

EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME

An interventional study of High Intensity Laser Therapy Group and Ultrasound and Transcutaneous Electrical Nerve Stimulation Group in Physical Therapy and Orthopedic Disorder, sponsored by Istanbul Medipol University Hospital. Status unknown at 1 site in Turkey. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Physical Therapy
  • Orthopedic Disorder

Keywords

  • Patellofemoral pain
  • High intensity laser therapy
03

In context

Patellofemoral Pain Syndrome

295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.

This study's planned enrollment of 45 is close to the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    High Intensity Laser Therapy Group

    Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions

    Other: High Intensity Laser Therapy Group

  • 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

  • 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

Interventions

  • OtherHigh Intensity Laser Therapy Group

    High Intensity Laser Therapy (HILT) and exercises will be used.

  • OtherUltrasound and Transcutaneous Electrical Nerve Stimulation Group

    Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.

  • OtherUltrasound and Interferential Current Stimulation Group

    Ultrasound (US) ,interferential current stimulation and exercise will be used.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 minutes

  2. 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

    Time frame: 10minutes

  3. 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).

    Time frame: 5 minutes

  4. 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.

    Time frame: 10 minutes

  5. 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.

    Time frame: 10 minutes

  6. 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).

    Time frame: 5 minutes

  7. 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.

    Time frame: 10 minutes

07

Study locations

1 site
  • Ozge Ozlu
    Istanbul, Beykoz 34820, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: No — When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05075525
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
ozluozge (Principal Investigator, MSc, PT, Istanbul Medipol University Hospital) — Principal investigator
First posted
Oct 12, 2021
Start date
Sep 10, 2021
Primary completion
Mar 10, 2022 (estimated)
Completion
Jun 10, 2022 (estimated)
Last update
Oct 12, 2021

Study contacts

OZGE OZLU
principal investigator · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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