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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05959148
Other study ID # RHPT/0021/0026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2021
Est. completion date September 29, 2022

Study information

Verified date July 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 29, 2022
Est. primary completion date September 29, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 18 Years
Eligibility 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

Study Design


Intervention

Other:
Monochromatic infrared energy
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 therapy
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).

Locations

Country Name City State
Saudi Arabia Ragab K. Elnaggar Al Kharj Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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". 3 months
Primary 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. 3 months
Secondary 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. 3 months
Secondary 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. 3 months
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