Patellofemoral Pain SyndromeNCT06610981
Laser Acupuncture on Pain, Range of Motion and Function in Patients With Patellofemoral Pain Syndrome
A study testing Laser acupuncture and traditional physical therapy 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?
- Laser acupuncture and traditional physical therapy
- 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
- 1 Oct 2024to 1 May 2025
- 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: Impact of Laser Acupuncture on Pain, Range of Motion and Function in Patients With Patellofemoral Pain Syndrome: A Randomized Sham-Controlled Trial
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
The treatment goals of patellofemoral pain syndrome are to reduce pain, increase muscle strength, increase flexibility, and correct the patellar movement tract. Conservative methods should be used before invasive methods when treating PFPS. One of the ways that people with PFPS may benefit from improved knee function and long-term pain reduction is by strengthening their quadriceps muscles, which primarily reduce force in the patellofemoral joint. Conservative methods described in the literature include the following: modifying activities; electrophysical modalities like biofeedback; therapeutic ultrasound; neuromuscular electrical stimulation; thermotherapy; interferential current; transcutaneous electrical nerve stimulation (TENS); knee braces; strengthening the hamstring, anterior tibialis, and gluteal muscles; stretching for iliotibial band and lateral retinaculum.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Laser acupuncture, traditional physical therapy, Sham laser acupuncture
- Keywords
- laser acuouncture, function, pain, range of motion
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureDevice
Laser acupuncture will be used in this study with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks
traditional physical therapyOther
exercise 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, 2 times /week for 4 weeks
Sham laser acupunctureDevice
Participants will receive laser acupuncture while the device is turned off.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Laser acupuncture group) | Experimental | Participants will receive Laser acupuncture with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks. Additionally, traditional physical therapy program will be conducted to participants in the study group. Receives: Device: Laser acupuncture; Other: traditional physical therapy |
| Group B (Sham-laser acupuncture group) | Sham comparator | Participants will receive the same intervention while the device turned off, in addition to the exercise 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, 2 times /week for 4 weeks. Receives: Other: traditional physical therapy; Device: Sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
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 (3)
Range of motion for knee flexion
A universal goniometer was used to assess knee flexion while the subject was lying prone. It is an accurate and trustworthy measuring device. It was assessed while resting prone and with the knee extended. While keeping the other foot in touch with the plinth, the patient was instructed to bring the heel of the leg being tested as near to the buttock as feasible. With one arm aligned with the lateral malleolus and the other with the greater trochanter, the fulcrum of the goniometry is situated on the lateral epicondyle of the examined knee. A range of motion of knee flexion ranged from 0-135°. The higher the range, the better the results.
Measured: 4 weeks
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
Range of motion for knee extension
The dominant limbs hip and knee were bent to a 90-degree angle for the first assessment, while the foot was kept in a relaxed position. Knee extension, as demonstrated by Norkin \&White with the universal goniometer. The normal ROM for knee extension is 135- 0º. Each person\'s knee extension range of motion was assessed three times, and the computations employed the arithmetic mean of the three measures. The lower the range, the better the results.
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 posted24 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Zeinab Ali Hamada, PhD, Study director, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610981
- Sponsor's protocol ID
- IRB Approval No. 2024-82
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allam NM, Alsirhani H, Alruwaili MB, Dosh DM, Alruwaili HM, Almazyad WH, Toson RA, Elimy DA, El-Sherbiny M, Ibrahim AM, Ebrahim HA, Nosseir N, Eladl MA, Ali ZA. Effect of laser acupuncture on pain, range of motion, and function in patellofemoral pain syndrome: a randomised controlled trial. Front Med (Lausanne). 2025 Jul 15;12:1613197. doi: 10.3389/fmed.2025.1613197. eCollection 2025.
PubMed 40735438
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Laser Acupuncture on Pain, Range of Motion and Function in Patients With Patellofemoral Pain Syndrome: A Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT06610981
- Acronym / sponsor ID
- IRB Approval No. 2024-82
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- laser acuouncture, function, pain, range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 24 Sep 2024 (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
The treatment goals of patellofemoral pain syndrome are to reduce pain, increase muscle strength, increase flexibility, and correct the patellar movement tract. Conservative methods should be used before invasive methods when treating PFPS. One of the ways that people with PFPS may benefit from improved knee function and long-term pain reduction is by strengthening their quadriceps muscles, which primarily reduce force in the patellofemoral joint. Conservative methods described in the literature include the following: modifying activities; electrophysical modalities like biofeedback; therapeutic ultrasound; neuromuscular electrical stimulation; thermotherapy; interferential current; transcutaneous electrical nerve stimulation (TENS); knee braces; strengthening the hamstring, anterior tibialis, and gluteal muscles; stretching for iliotibial band and lateral retinaculum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Laser acupuncture group) | Experimental | Device: Laser acupuncture, Other: traditional physical therapyParticipants will receive Laser acupuncture with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks. Additionally, traditional physical therapy program will be conducted to participants in the study group. |
| Group B (Sham-laser acupuncture group) | Sham comparator | Other: traditional physical therapy, Device: Sham laser acupunctureParticipants will receive the same intervention while the device turned off, in addition to the exercise 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, 2 times /week for 4 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 |
|---|---|---|
| Laser acupunctureLaser acupuncture will be used in this study with energy of 4 J per point for 80 s, with a total dosage of 24 J in each session, 2 times /week for 4 weeks | Device | Group A (Laser acupuncture group) |
| traditional physical therapyexercise 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, 2 times /week for 4 weeks | Other | Group A (Laser acupuncture group), Group B (Sham-laser acupuncture group) |
| Sham laser acupunctureParticipants will receive laser acupuncture while the device is turned off. | Device | Group B (Sham-laser acupuncture group) |
Primary outcome
Visual analogue scale
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.
3 secondary outcomes
Range of motion for knee flexion
Time frame: 4 weeks
Function of knee joint
Time frame: 4 weeks
Range of motion for knee extension
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 13 May 2025.
- Derived from this study: PubMed 40735438Allam NM, Alsirhani H, Alruwaili MB, Dosh DM, Alruwaili HM, Almazyad WH, Toson RA, Elimy DA, El-Sherbiny M, Ibrahim AM, Ebrahim HA, Nosseir N, Eladl MA, Ali ZA. Effect of laser acupuncture on pain, range of motion, and function in patellofemoral pain syndrome: a randomised controlled trial. Front Med (Lausanne). 2025 Jul 15;12:1613197. doi: 10.3389/fmed.2025.1613197. eCollection 2025.
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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.
Zeinab Ali Hamada, PhD study director
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and traditional physical therapy 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 13 May 2025. 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?
Visual analogue scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06610981, which also lists 1 linked publication.
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 13 May 2025.