NCT05075525

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

September 29, 2021

Last Update Submit

October 11, 2021

Conditions

Keywords

Patellofemoral painHigh intensity laser therapy

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

High Intensity Laser Therapy Group

EXPERIMENTAL

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

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

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

Other: Ultrasound and Interferential Current Stimulation Group

Interventions

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

High Intensity Laser Therapy Group

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

Ultrasound and Transcutaneous Electrical Nerve Stimulation Group

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

Ultrasound and Interferential Current Stimulation Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral patellofemoral pain syndrome diagnosed by a doctor
  • years old
  • pain from prolonged sitting, climbing and descending stairs, running,knee bend more than 3 months
  • positive patellar compression and clarke's tests.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozge Ozlu

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

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

MeSH Terms

Conditions

Musculoskeletal DiseasesPatellofemoral Pain Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Joint Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • OZGE OZLU

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blinded to allocation and outcomes measures.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MSc, PT

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

September 10, 2021

Primary Completion

March 10, 2022

Study Completion

June 10, 2022

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.

Locations