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Optimal High-Intensity Laser Therapy (HILT) Parameters for Pain and Function in Patients With Moderate Knee Osteoarthritis: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to find the best settings (dose) for High-Intensity Laser Therapy (HILT) to reduce pain and improve function in people with moderate knee osteoarthritis. Participants will be randomly assigned to receive one of three different doses of HILT (low, medium, or high) or a sham (placebo) laser treatment, three times a week for four weeks. The main outcomes measured will be changes in knee pain (using a pain scale) and knee function (using a questionnaire) from the beginning to the end of the 4-week treatment period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age between 45 and 75 years, inclusive. Clinical diagnosis of knee osteoarthritis according to American College of Rheumatology (ACR) criteria (knee pain plus at least 3 of 6: age \>50, morning stiffness \<30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth).

• Radiographic evidence of knee osteoarthritis corresponding to Kellgren-Lawrence grade II or III in the target knee.

• Average knee pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) during weight-bearing activities in the past week.

• Willingness and ability to attend 3 sessions per week for 4 weeks and attend all assessment sessions.

Locations
Other Locations
Egypt
Faculty of Physical Therapy, Al Hayah University
RECRUITING
Cairo
Contact Information
Primary
Ibrahim Zoheiry, Ph.D
ibrahim.alzoheiry@hotmail.com
01277774949
Backup
Mohamed ElMeligie, Ph.D
mohamed.elmeligie@ahuc.edu.eg
01159880001
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 140
Treatments
Experimental: Low-Dose HILT (10 J/cm²)
Participants receive High-Intensity Laser Therapy at a dosage of 10 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).
Experimental: Medium-Dose HILT (15 J/cm²)
Participants receive High-Intensity Laser Therapy at a dosage of 15 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).
Experimental: High-Dose HILT (20 J/cm²)
Participants receive High-Intensity Laser Therapy at a dosage of 20 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).
Sham_comparator: Sham HILT
Participants receive a sham High-Intensity Laser Therapy procedure using the same device and application technique, but with no energy delivered, 3 times per week for 4 weeks (12 sessions total).
Related Therapeutic Areas
Sponsors
Leads: Al Hayah University In Cairo

This content was sourced from clinicaltrials.gov