Patellofemoral Pain SyndromeNCT05959148
Adjuvant Effects of Monochromatic Infrared Energy in Rehabilitation of Adolescents With Patellofemoral Pain Syndrome
A study testing Monochromatic infrared energy and Traditional physical therapy in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study assessed if integrating monochromatic infrared energy (MIRE) would affect pain, dynamic postural control, functional status, and health-related quality of life in adolescents with patellofemoral pain syndrome (PFPS). Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Monochromatic infrared energy and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Oct 2021to 29 Sep 2022
- 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between15 and18 years.
- Anterior-knee or retro-patellar pain that increases with activities like squatting, running, prolonged sitting, or stair climbing.
- PFPS with insidious onset for more than 6 weeks without any traumatic incidence.
- Not participating in a regular exercise program within the last three months.
Who cannot join
- Meniscal tears
- Collateral/cruciate ligament injury
- Knee arthritis
- History of hip/knee surgery
- Previous patellar subluxation/dislocation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Would Integrating Monochromatic Infrared Energy Into the Physical Rehabilitation of Adolescents With Patellofemoral Pain Syndrome Have Any Advantageous Effects? a Randomized Controlled Trial
This study assessed if integrating monochromatic infrared energy (MIRE) would affect pain, dynamic postural control, functional status, and health-related quality of life in adolescents with patellofemoral pain syndrome (PFPS). Forty-six patients with PFPS were randomly allocated to the MIRE group (n = 23, received the received MIRE in addition to the traditional physical therapy program) or the control group (n = 23, received the traditional physical therapy program only). Both groups were assessed for pain, dynamic postural control, functional status, and health-related quality before and after intervention.
Read the detailed description
Forty-six adolescents with PFPS were recruited from the university's outpatient orthopedic and physical therapy clinics and two referral hospitals in AlKharj, Saudi Arabia. The study included patients who were 15-18 years old, had anterior-knee or retro-patellar pain that increase with activities like squatting, running, prolonged sitting, or stair climbing, had PFPS with insidious onset for more than 6 weeks without any traumatic incidence, and were not participating in a regular exercise program in the past 3 months. Patients who had meniscal tears, collateral/cruciate ligament injury, knee arthritis, a history of knee/hip surgery, or previous patellar subluxation/dislocation were excluded.
Outcome measures
Pain: Pain during rest and/or movement was assessed using the Numerical Pain Rating Scale.
Dynamic postural control: The dynamic postural control was assessed through the modified star excursion balance test (mSEBT).
Functional status: The functional status was evaluated using the Arabic version of the Anterior Knee Pain Questionnaire (Kujala Questionnaire).
Quality of life: The quality of life was assessed through the self-report Pediatric Quality of Life Inventory.
Interventions
The MIRE group underwent MIRE application on the affected knee for 40 minutes, 3 times a week for 3 consecutive months. The MIRE was delivered using an Anodyne Therapy Professional Infrared Therapy System (parameter: a wavelength of 890 nm and radiant power at a rate of 6.24 W). Participants in the MIRE group further received the traditional physical therapy program (60 minutes/session) that consisted of stretching and strengthening exercises for the muscles surrounding the hip and knee, balance exercises, as well as other electrotherapeutic modalities (ultrasound and hot application). The control group received the traditional physical therapy program only.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Monochromatic infrared energy, Traditional physical therapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monochromatic infrared energyOther
The monochromatic infrared energy was delivered through an Anodyne Therapy Professional Infrared Therapy System. Light energy (parameter: a wavelength of 890 nm and radiant power at a rate of 6.24 W) was produced through 8 array diode therapy pads applied on both knees (on the medial, lateral, anterior, and posterior aspects of each knee), each including 60 super-luminescent gallium-aluminum arsenide diodes. The MIRE was applied for 40 minutes/session, three times a week, for three successive months.
Traditional physical therapyOther
The traditional physical therapy program consisted of stretching and strengthening exercises for the muscles surrounding the hip and knee, balance exercises, as well as other electrotherapeutic modalities (ultrasound and hot application).
| Study group | Role | What they receive |
|---|---|---|
| MIRE group | Experimental | Participants in this group underwent MIRE application in addition to the traditional physical therapy program Receives: Other: Monochromatic infrared energy |
| Control | Active comparator | Participants in this group received the traditional physical therapy program only. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Participants reported how much they feel pain during rest and/or movement on the 0-10 Visual Analogue Scale, where 0 represents "no pain" and 10 indicates the "worst possible pain".
Measured: 3 months
Dynamic postural control
The dynamic postural control was assessed through the modified star excursion balance test (mSEBT). Participants stood in the middle of a floor grid with three reach lines creating a Y shape. They were told to stand on one limb and extend as far as they could with the distal end of the reaching limb pointed in each anterior, posteromedial, and posterolateral direction. The distance from the center to the point of the foot reach was then measured with a measuring tape (in/cm), and the reaching limb was restored to the starting position. The composite reach distance of the three directions was calculated and normalized to the length of the leg and used for data analysis. The higher the normalized mSEBT score the better the postural control.
Measured: 3 months
Secondary outcomes (2)
Functional status
To evaluate functional status, the Arabic version of the Anterior Knee Pain Questionnaire (Kujala Questionnaire) was utilized. It measures the functional limitations imposed on by patellofemoral pain with 13 self-reported items. Six physical activities-sitting, squatting, walking, climbing stairs, leaping, and running-were chosen to assess pain, abnormal patellar movement, edema, limited knee flexion, and quadriceps atrophy. The score is 0 to 100, with 100 representing no discomfort or functional impairment and 0 representing total functional incapacity.
Measured: 3 months
Life quality
To evaluate the quality of life, the self-report Pediatric Quality of Life Inventory (PedsQL) was utilized. It is a 23-item multidimensional assessment of children's and adolescents' health-related quality of life that is broken down into four domains: physical (8 items), emotional (5 items), social (5 items), and school-related (3 items). Scores range from 0 (never) to 4 (almost always) for each item. The scale for the items is linear reversed on a 0-100 scale, with 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores denotes better quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start3 Oct 2021
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
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
- A prospective, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K. Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959148
- Sponsor's protocol ID
- RHPT/0021/0026
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Would Integrating Monochromatic Infrared Energy Into the Physical Rehabilitation of Adolescents With Patellofemoral Pain Syndrome Have Any Advantageous Effects? a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05959148
- Acronym / sponsor ID
- RHPT/0021/0026
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 25 Jul 2023 (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.
This study assessed if integrating monochromatic infrared energy (MIRE) would affect pain, dynamic postural control, functional status, and health-related quality of life in adolescents with patellofemoral pain syndrome (PFPS). Forty-six patients with PFPS were randomly allocated to the MIRE group (n = 23, received the received MIRE in addition to the traditional physical therapy program) or the control group (n = 23, received the traditional physical therapy program only). Both groups were assessed for pain, dynamic postural control, functional status, and health-related quality before and after intervention.
Detailed description
Forty-six adolescents with PFPS were recruited from the university's outpatient orthopedic and physical therapy clinics and two referral hospitals in AlKharj, Saudi Arabia. The study included patients who were 15-18 years old, had anterior-knee or retro-patellar pain that increase with activities like squatting, running, prolonged sitting, or stair climbing, had PFPS with insidious onset for more than 6 weeks without any traumatic incidence, and were not participating in a regular exercise program in the past 3 months. Patients who had meniscal tears, collateral/cruciate ligament injury, knee arthritis, a history of knee/hip surgery, or previous patellar subluxation/dislocation were excluded.
Outcome measures
Pain: Pain during rest and/or movement was assessed using the Numerical Pain Rating Scale.
Dynamic postural control: The dynamic postural control was assessed through the modified star excursion balance test (mSEBT).
Functional status: The functional status was evaluated using the Arabic version of the Anterior Knee Pain Questionnaire (Kujala Questionnaire).
Quality of life: The quality of life was assessed through the self-report Pediatric Quality of Life Inventory.
Interventions
The MIRE group underwent MIRE application on the affected knee for 40 minutes, 3 times a week for 3 consecutive months. The MIRE was delivered using an Anodyne Therapy Professional Infrared Therapy System (parameter: a wavelength of 890 nm and radiant power at a rate of 6.24 W). Participants in the MIRE group further received the traditional physical therapy program (60 minutes/session) that consisted of stretching and strengthening exercises for the muscles surrounding the hip and knee, balance exercises, as well as other electrotherapeutic modalities (ultrasound and hot application). The control group received the traditional physical therapy program only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| MIRE group | Experimental | Other: Monochromatic infrared energyParticipants in this group underwent MIRE application in addition to the traditional physical therapy program |
| Control | Active comparator | Other: Traditional physical therapyParticipants in this group received the traditional physical therapy program only. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between15 and18 years.
- Anterior-knee or retro-patellar pain that increases with activities like squatting, running, prolonged sitting, or stair climbing.
- PFPS with insidious onset for more than 6 weeks without any traumatic incidence.
- Not participating in a regular exercise program within the last three months.
Key exclusion criteria (5 listed)
- Meniscal tears
- Collateral/cruciate ligament injury
- Knee arthritis
- History of hip/knee surgery
- Previous patellar subluxation/dislocation
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 |
|---|---|---|
| Monochromatic infrared energyThe monochromatic infrared energy was delivered through an Anodyne Therapy Professional Infrared Therapy System. Light energy (parameter: a wavelength of 890 nm and radiant power at a rate of 6.24 W) was produced through 8 array diode therapy pads applied on both knees (on the medial, lateral, anterior, and posterior aspects of each knee), each including 60 super-luminescent gallium-aluminum arsenide diodes. The MIRE was applied for 40 minutes/session, three times a week, for three successive months. | Other | MIRE group |
| Traditional physical therapyThe traditional physical therapy program consisted of stretching and strengthening exercises for the muscles surrounding the hip and knee, balance exercises, as well as other electrotherapeutic modalities (ultrasound and hot application). | Other | Control |
Primary outcome
Pain intensity
Time frame: 3 months
Participants reported how much they feel pain during rest and/or movement on the 0-10 Visual Analogue Scale, where 0 represents "no pain" and 10 indicates the "worst possible pain".
Dynamic postural control
Time frame: 3 months
The dynamic postural control was assessed through the modified star excursion balance test (mSEBT). Participants stood in the middle of a floor grid with three reach lines creating a Y shape. They were told to stand on one limb and extend as far as they could with the distal end of the reaching limb pointed in each anterior, posteromedial, and posterolateral direction. The distance from the center to the point of the foot reach was then measured with a measuring tape (in/cm), and the reaching limb was restored to the starting position. The composite reach distance of the three directions was calculated and normalized to the length of the leg and used for data analysis. The higher the normalized mSEBT score the better the postural control.
2 secondary outcomes
Functional status
Time frame: 3 months
Life quality
Time frame: 3 months
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 Jul 2023.
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Ragab K. Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monochromatic infrared energy and Traditional physical therapy in people with Patellofemoral Pain Syndrome, run by Cairo University at 1 site in Saudi Arabia.
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 4 inclusion and 5 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 Jul 2023. 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 Saudi Arabia. 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. 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: 3 months). The study lists 2 primary outcomes in all. 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 Jul 2023.