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Adjuvant Effects of Monochromatic Infrared Energy in Rehabilitation of Adolescents With Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Monochromatic infrared energy
Traditional physical therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ragab K. Elnaggar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MIRE group

Control

Arm Description

Participants in this group underwent MIRE application in addition to the traditional physical therapy program

Participants in this group received the traditional physical therapy program only.

Outcomes

Primary Outcome Measures

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".
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 15, 2023
Last Updated
July 15, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05959148
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The outcome assessor was blinded to the treatment assignment.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRE group
Arm Type
Experimental
Arm Description
Participants in this group underwent MIRE application in addition to the traditional physical therapy program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in this group received the traditional physical therapy program only.
Intervention Type
Other
Intervention Name(s)
Monochromatic infrared energy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain intensity
Description
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".
Time Frame
3 months
Title
Dynamic postural control
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional status
Description
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.
Time Frame
3 months
Title
Life quality
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K. Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

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Adjuvant Effects of Monochromatic Infrared Energy in Rehabilitation of Adolescents With Patellofemoral Pain Syndrome

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