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

NCT05959148 | Completed

• 1 other identifier: RHPT/0021/0026
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Functional status

  3 months

• Life quality

  3 months

Study Arms (2)

MIRE group

EXPERIMENTAL

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

Other: Monochromatic infrared energy

Control

ACTIVE COMPARATOR

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

Other: Traditional physical therapy

Interventions

Monochromatic infrared energy OTHER

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.

MIRE group

Traditional physical therapy OTHER

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).

Control

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ragab K. Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The outcome assessor was blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: July 25, 2023
• Study Start: October 3, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

SA (1)