High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis

University of Rzeszow

Status: Not yet enrolling

Conditions: Knee Osteoarthritis (Knee OA)

Treatments: Device: High-Intensity Laser Therapy (HILT); Behavioral: Conventional Physiotherapy; Device: Sham High-Intensity Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07661407

41/03/2026

Details and patient eligibility

About

This randomized placebo-controlled trial aims to evaluate the effectiveness of High-Intensity Laser Therapy (HILT) as an adjunct to standard outpatient physiotherapy in patients with knee osteoarthritis. Seventy-two participants will be randomly assigned to receive either conventional physiotherapy combined with active HILT or conventional physiotherapy combined with sham HILT. Outcomes related to pain, knee function, physical performance, muscle strength, range of motion, psychosocial factors, quality of life and body composition will be assessed at baseline, after the intervention, and at 8-week follow-up.

Full description

Knee osteoarthritis is one of the leading causes of pain and disability among older adults. Although physiotherapy constitutes a cornerstone of conservative management, the clinical effectiveness of High-Intensity Laser Therapy remains uncertain due to methodological heterogeneity of available studies. This prospective randomized placebo-controlled trial will evaluate whether HILT provides additional benefits when combined with standard physiotherapy.

Participants aged 40-75 years with radiographically confirmed mild-to-moderate knee osteoarthritis and pain intensity of at least 4 points on the Visual Analogue Scale will be enrolled. Participants will be randomly assigned in a 1:1 ratio using block randomization. The intervention period will last two weeks. Both groups will receive the same physiotherapy programme consisting of aerobic, strengthening, balance, proprioceptive, stretching, gait and functional exercises. The experimental group will receive active HILT, whereas the control group will receive sham HILT.

Assessments will be performed at baseline, immediately after treatment and 8 weeks after treatment completion.

Enrollment: 72 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Radiographically confirmed knee osteoarthritis
• Mild-to-moderate disease severity
• Pain ≥4 on VAS for at least 3 months
• Ability to participate in physiotherapy
• Informed consent

Exclusion criteria

• Advanced OA requiring surgery
• Previous knee arthroplasty
• Knee instability
• Acute inflammation
• Neurological disorders affecting gait
• Neuropathies or myopathies
• Active inflammatory arthritis
• Recent lower-limb injury (<6 months)
• Intra-articular injections within 3 months
• Cancer, pregnancy, epilepsy
• Electronic implants or pacemaker
• Active local infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Conventional Physiotherapy + HILT

Experimental group

Treatment:

Behavioral: Conventional Physiotherapy

Device: High-Intensity Laser Therapy (HILT)

Conventional Physiotherapy + Sham HILT

Sham Comparator group

Treatment:

Device: Sham High-Intensity Laser Therapy

Behavioral: Conventional Physiotherapy