Clinical trial NCT05959148: Adjuvant Effects of Monochromatic Infrared Energy in Rehabilitation of Adolescents With Patellofemoral Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Meniscal tears
* Collateral/cruciate ligament injury
* Knee arthritis
* History of hip/knee surgery
* Previous patellar subluxation/dislocation

Primary outcomes:
measure: Pain intensity
timeFrame: 3 months
measure: Dynamic postural control
timeFrame: 3 months
Secondary outcomes:
measure: Functional status
timeFrame: 3 months
measure: Life quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K. Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: