Patellofemoral Pain SyndromeNCT07655258
High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome
A study testing high-intensity laser acupuncture and Exercise therapy program in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- high-intensity laser acupuncture and Exercise therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2026to 31 Aug 2026
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- high-intensity laser acupuncture and Exercise therapy program, Sham laser acupuncture
- Keywords
- Patellofemoral pain syndrome, high-intensity laser acupuncture, Function, patient satisfaction
- Medical subject headings
- Patellofemoral Pain Syndrome, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity laser acupuncture and Exercise therapy programDevice
Also called high-power laser acupuncture
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
Sham laser acupunctureOther
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
| Study group | Role | What they receive |
|---|---|---|
| high-intensity laser acupuncture and exercise therapy program. | Experimental | The patients will receive high-intensity laser acupuncture and exercise therapy program.three times a week for four weeks. Receives: Device: high-intensity laser acupuncture and Exercise therapy program |
| sham laser acupuncture and exercise therapy program. | Sham comparator | The patients will receive sham acupuncture laser and exercise therapy program three times a week for four weeks. Receives: Other: Sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
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.
Measured: 4 weeks
Secondary outcomes (2)
Function of knee joint
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.
Measured: 4 weeks
patient Satisfaction
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'.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start20 Jun 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- high-intensity laser acupuncture and exercise therapy program
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655258
- Sponsor's protocol ID
- PT.BU.EC.42
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Laser Acupuncture for Treating Patellofemoral Pain Syndrome: Impact on Pain, Function, and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07655258
- Acronym / sponsor ID
- PT.BU.EC.42
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral pain syndrome, high-intensity laser acupuncture, Function, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 17 Jun 2026 (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.
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%.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- high-intensity laser acupuncture and exercise therapy program
| Arm | Type | Receives |
|---|---|---|
| high-intensity laser acupuncture and exercise therapy program. | Experimental | Device: high-intensity laser acupuncture and Exercise therapy programThe patients will receive high-intensity laser acupuncture and exercise therapy program.three times a week for four weeks. |
| sham laser acupuncture and exercise therapy program. | Sham comparator | Other: Sham laser acupunctureThe patients will receive sham acupuncture laser and exercise therapy program three times a week for four weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 acupuncture and Exercise therapy programAlso: high-power laser acupunctureThe 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 | Device | high-intensity laser acupuncture and exercise therapy program. |
| Sham laser acupunctureSham 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 | Other | sham laser acupuncture and exercise therapy program. |
Primary outcome
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.
2 secondary outcomes
Function of knee joint
Time frame: 4 weeks
patient Satisfaction
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 acupuncture and Exercise therapy program in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 25 Sep 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.