Laser-assisted exercise for adolescent with patellofemoral pain syndrome
| ISRCTN | ISRCTN78783043 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78783043 |
| Sponsor | Prince Sattam Bin Abdulaziz University |
| Funder | Deanship of Scientific Research, Prince Sattam bin Abdulaziz University |
- Submission date
- 21/11/2025
- Registration date
- 25/11/2025
- Last edited
- 24/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Patellofemoral Pain Syndrome (PFPS) is a common knee condition in adolescents, causing pain around the kneecap. This pain is often made worse by activities like running or squatting and can lead to a fear of movement, reduced physical function, and a lower quality of life. This study aimed at investigating the synergetic effects of low-energy laser therapy and a standard exercise program. This study aims to see if the combined approach is more effective at reducing pain, overcoming fear of movement, improving knee function, and enhancing quality of life in adolescents with PFPS compared to exercise alone.
Who can participate?
Adolescents aged 10 to 18 years, of either sex, who have been diagnosed with PFPS by an orthopedic physician. Eligible participants had knee pain for more than three months, with a pain level greater than 3 on a 10-point scale, which gets worse with activity and improves with rest.
What does the study involve?
In this study, participants were be randomly allocated into different groups. The groups received different combinations of the two main treatments:
• Low-energy laser therapy: A non-invasive, painless light therapy applied to the knee.
• Exercise program: A series of specific exercises tailored to the individual, focusing on strengthening and improving movement.
All treatments were supervised by a physical therapist. Before and after the intervention period, participants completed assessments, including:
• Pain intensity
• Kinesophobia
• Disability
• Quality of life
What are the possible benefits and risks of participating?
Benefits:
Participants may experience improvements in their knee pain, find it easier to perform daily activities and sports, and have a better overall quality of life. Their participation will also help researchers design better treatment plans for other young people with similar knee pain.
Risks:
The risks are minimal. The laser therapy is very safe, with the main precaution being the use of protective goggles. The exercises may cause temporary muscle soreness or a short-term increase in knee pain. All sessions are closely supervised by a qualified therapist to ensure safety and adjust the program as needed.
Where is the study run from?
The study was conducted at the Physical Therapy Clinic, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, in Al-Kharj, Kingdom of Saudi Arabia.
When is the study starting and how long is it expected to run for?
August 2022 to July 2023.
Who is funding the study?
The Deanship of Scientific Research at PSAU, Kingdom of Saudi Arabia
Who is the main contact?
Prof. Ragab K. Elnaggar, rke_pt2001@yahoo.com; r.elnaggar@psau.edu.sa
Contact information
Principal investigator, Scientific, Public
Prince Sattam Bin Abdulaziz University
Abdullah Ibn Amer St.
Al-Kharj
11942
Saudi Arabia
| Phone | +96611588631 |
|---|---|
| r.elnaggar@psau.edu.sa |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Participant information sheet | 48537_PIS.pdf | |
| Scientific title | Synergetic effects of low-energy laser and exercise on pain, kinesophobia, disability, and quality of life in adolescents with patellofemoral pain syndrome: A randomized clinical trial | |
| Study objectives | This study aimed to determine if integrating low-energy laser therapy (LELT) with exercises is more effective than exercises alone for improving pain, kinesophobia, disability, and quality of life in adolescents with patellofemoral pain syndrome. | |
| Ethics approval(s) |
Approved 21/08/2022, Physical Therapy Research Ethics Committee (College of Applied Medical Science, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia; +96615886301; a.osailan@psau.edu.sa), ref: RHPT/0022/0029 | |
| Health condition(s) or problem(s) studied | Patellofemoral Pain Syndrome | |
| Intervention | This investigation recruited 64 children with a confirmed patellofemoral pain syndrome. Randomization Method: The study employed stratified randomization method to balance the study groups. Four homogenous strata were created considering age and gender as relevant stratification factors. An independent researcher, not involved in recruitment or assessment, generated the randomization sequence using a web-based random number generator. This sequence was concealed from the investigators enrolling participants and administering the interventions to ensure blinding was maintained. Participants were randomized into three cohorts: A low energy laser group (received exercise + low energy laser therapy). A control group; received exercise only Participants in both groups performed a standardized 35-minute core exercise program focused on lower limb strengthening, flexibility, and balance/proprioceptive training. Each session was framed by a 5-minute warm-up and a 5-minute cool-down, incorporating dynamic and static stretching, respectively, resulting in a total session time of approximately 45 minutes. Participants in the “low energy laser therapy group” underwent an additional active laser treatment applied to eight specific points around the kneecap for 30 seconds per point, totaling 8 minutes per session. The treatment used an infrared laser with a wavelength of 903 nm, delivering a dose of 1.5 J per point and a total of 24 J per session, accumulating to 864 J over the full 36-session intervention. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 27/07/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 64 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Age of 10-18 years 2. Verified asthma diagnosis of patellofemoral pain syndrome based on the ICD classification system (ICD-10 code for PFPS: M22.2X9) 3. Pain more than 3 on (0-10 pain scale). 4. Persistent pain more than 3 months 5. Pain get worse with activities and get better with rest. |
| Key exclusion criteria | 1. History of knee surgery 2. Recent trauma 3. Corticosteroids or anti-inflammatory medications in the past 6 months 4. Patellar subluxation or dislocation 5. Contraindications to low-energy laser therapy (e.g., local infection, malignancy, photosensitizing drug use) |
| Date of first enrolment | 28/08/2022 |
| Date of final enrolment | 27/11/2022 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 24/11/2025 | No | No | ||
| Other files | 24/11/2025 | No | No | ||
| Participant information sheet | 24/11/2025 | No | Yes | ||
| Statistical Analysis Plan | 24/11/2025 | No | No |
Additional files
- 48537_PIS.pdf
- Participant information sheet
- 48537_Data Collection Sheet.pdf
- Other files
- 48537_Intervention Follow-up Form.pdf
- Other files
- 48537_SAP.pdf
- Statistical Analysis Plan
Editorial Notes
24/11/2025: Study’s existence confirmed by the Physical Therapy Research Ethics Committee at Prince Sattam bin Abdulaziz University, Kingdom of Saudi Arabia.
