- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655258
High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome
June 12, 2026 updated by: Doaa Ayoub Elimy Mohammed, Cairo University
High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome: Impact on Pain, Function, and Patient Satisfaction
Patellofemoral pain syndrome (PFPS) is among the most prevalent forms of knee discomfort.
The main complaint is typically anterior knee pain, which gets worse while jumping, bending knee, going up or down stairs, or sitting for long periods of time with bent knee.
Teens and early adulthood are commonly affected by patellofemoral pain syndrome, with a higher frequency in females.
In healthy general populations, the prevalence of patellofemoral pain syndrome is 22.7%, and in teens, it is 28.9%.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Patellofemoral pain syndrome (PFPS) is a common cause of anterior knee pain that limits activities such as stair climbing, squatting, running, and prolonged sitting, leading to reduced function and participation (Crossley et al., 2016; Gaitonde et al., 2019).
Exercise therapy is considered a key conservative treatment, especially combined hip and knee exercises, but additional non-invasive modalities may help improve pain relief and recovery (Collins et al., 2018).
Laser acupuncture provides non-invasive stimulation of acupuncture points and may offer analgesic and functional benefits without needle insertion.
Recent studies suggest that laser acupuncture and high-intensity laser therapy may improve pain and function in patients with PFPS (Ozlu et al., 2024).
Therefore, this study aims to evaluate the effect of high-intensity laser acupuncture on pain, knee function, and patient satisfaction in patients with PFPS.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Doaa A Elimy, lecturer
- Phone Number: 00201066474654
- Email: do3aayoub25@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with patellofemoral pain syndrome (positive Clarkes sign and Waldron test)
- Age from 18 to 25 years
- Patients suffering from pain which aggravated by prolonged sitting, stair climbing, running, squatting, kneeling, hopping\jumping, overuse activities and relieved by rest for at least 3 months
- Visual analog scale (VAS) greater than 3 points in daily activity
- The ability to participate in the study and follow the treatment schedule.
Exclusion Criteria:
- Physiotherapy in the last 12 months
- Intra-articular injection in the last 3 months
- Other knee disorders such as: (osteoarthritis, previous knee surgery, history of knee arthroplasty, or traumatic injury related joint deformity)
- BMI greater than or equal 30
- Pregnancy
- Pacemaker insertion
- Photosensitivity
- History of using oral analgesic or NSAIDs in the previous 4 weeks,
- History of malignancy, psychiatric disorder, mental retardation, neurologic dysfunction, diabetes mellitus, or uncontrolled hypertension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: high-intensity laser acupuncture and exercise therapy program.
The patients will receive high-intensity laser acupuncture and exercise therapy program.three
times a week for four weeks.
|
The experimental group will receive high-intensity lasers and the treatment will be applied at over six points (ST34, ST 35, GB34, EX-LE4, SP9, and SP10) Exercise therapy program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 3 times /week for 4 weeks
Other Names:
|
|
Sham Comparator: sham laser acupuncture and exercise therapy program.
The patients will receive sham acupuncture laser and exercise therapy program three times a week for four weeks.
|
Sham laser acupuncture and exercise therapy Program.
Exercise therapy program consisted of stretching for hamstring, gastrocnemius and iliotibial band, and strengthening exercises, which include isometric quadriceps exercises, straight leg raising, lateral straight leg raise, isometric hip adduction and squat to 30° knee flexion, 3 times /week for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 4 weeks
|
The visual analogue scale represents the pain range that a patient thinks they might experience.
The line is typically 10 centimetres long, with or without markings at each centimetre serves as a representation of the range.
The worst pain the patient could possibly envision is represented by one end, while; no pain; is represented by the other.
The patient marks the scale by drawing a line on it to indicate the amount of discomfort they are experiencing from 0-10.
Higher scores represent worse pain.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function of knee joint
Time Frame: 4 weeks
|
A scale known as Kujala patellofemoral score will be used for assessment of the function of the patellofemoral pain syndrome.
The scores of this rating system vary from 100 (a normal, painless, totally functional knee) to 0 (severe pain and dysfunction in the knee).
Haddad et al. conducted research on the validity and reliability of the Arabic version of the scale.
The greater the scores, the better the results.
|
4 weeks
|
|
patient Satisfaction
Time Frame: 4 weeks
|
The satisfaction VAS will be used to measure patient satisfaction.
The patient will be by placing an indicator at 0 to100 milliliters line.
Zero usually represents 'no satisfaction at all' whereas the upper limit represents 'the best satisfaction ever'.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 20, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT.BU.EC.42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome
-
University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
-
Lauren EricksonAmerican College of Sports MedicineCompleted
-
Beijing Sport UniversityCompletedPatellofemoral PainChina
-
Boston Children's HospitalEnrolling by invitationPatellofemoral PainUnited States
-
Beijing Sport UniversityNot yet recruitingPatellofemoral Pain, PFP
-
Beijing Sport UniversityNot yet recruiting
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Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Ahram Canadian UniversityNot yet recruitingPatellofemoral Pain (PFPS)Egypt
-
Beijing Sport UniversityCompletedPatellofemoral Pain, PFPChina
-
Istanbul University - CerrahpasaRecruitingPatellofemoral Pain, PFPTurkey (Türkiye)
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