Laser: EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05075525
Collaborator
(none)
45
1
3
9
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Intensity Laser Therapy Group
  • Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
  • Other: Ultrasound and Interferential Current Stimulation Group
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Participants are blinded to allocation and outcomes measures.
Primary Purpose:
Treatment
Official Title:
EFFECT OF HIGH INTENSITY LASER THERAPY ON PAIN AND LOWER EXTREMITY FUNCTION IN PATELLOFEMORAL PAIN SYNDROME
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Mar 10, 2022
Anticipated Study Completion Date :
Jun 10, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pain status [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

  2. Range of motion assesment [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

  3. Functionality [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).

  4. Muscle stength assesment [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.

  5. Pain threshold assessment [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.

  6. Severity and function of patellofemoral pain [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).

  7. Function of lower extremity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ozge Ozlu Istanbul Beykoz Turkey 34820

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: OZGE OZLU, Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ozluozge, Principal Investigator, MSc, PT, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05075525
Other Study ID Numbers:
  • ozgeozlu
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ozluozge, Principal Investigator, MSc, PT, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021