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High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

Additional Effect of High-Intensity Laser Therapy Over Conventional Physiotherapy Related to Pain and Function in Patients With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, 12-Week Follow-up Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06549543
Enrollment
43
Registered
2024-08-12
Start date
2022-04-01
Completion date
2024-02-01
Last updated
2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

high-intensity laser, rehabilitation, pain, osteoarthritis

Brief summary

The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).

Detailed description

The study was performed in Baskent University Physical Therapy and Rehabilitation Unit. 43 patients of both sexes, who were diagnosed clinical and radiographic knee osteoarthritis, with Kellgren Lawrence Grade 2 and 3, were randomly assigned in two groups. Group 1 (n = 21) received TENS, HP, exercises (EX), and High-Intensity Laser Therapy (HILT; Nd:yag laser, 10W). Group 2 (n = 22) received the same interventions but placebo HILT. All interventions were applied for 10 sessions. The Visual Analog Scale (VAS), Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC), and Lequesne Algofunctional Index (LAI) were performed before, after, and at 12-week follow-up.

Interventions

OTHERHigh Intensity Laser Therapy

HILT is applied per session, with a maximum of 10.0 W, a mean of 5.7 W, a dose of 99 J/cm², and a total energy flux of 2079 J were applied over 6 minutes and 5 seconds on a 21 cm² field on the medial aspect of the knee joint.

OTHERTranscutaneous Electrical Nerve Stimulation

TENS is an analgesic modality of physical therapy

OTHERHotpacks

Hotpacks is a thermoanalgesia modality of physical therapy

OTHERSHAM - High Intensity Laser Therapy

for control group, sham HILT was applied, with lights on but no laser beam

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Both the participants, investigators and outcomes assessors were blinded throughout the study.

Intervention model description

patients were assigned into two groups. Both groups received conventional physiotherapy and exercise therapy. Group 1 was the experimental group, and group 2 was the control group.

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* both sexes and age between 40 and 65; * pain at least 3 months on single or both knees * diagnosed as KOA with Kellgren Lawrence (KL) Grade 2 or 3 KOA on weight-bearing anteroposterior X-ray images * normal serum acute phase reactants and uric acid levels * had no major effusion in the joint.

Exclusion criteria

* therapeutic joint injection in the last 6 months * physical therapy and/or HILT in the last 3 months * any surgical invention for the knee joint * malignancy in the last 5 years.

Design outcomes

Primary

MeasureTime frameDescription
The Visual Analog Scale (VAS)12 weeksThe VAS was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Min score was 0 and max score was 100. Higher scores on the VAS indicate greater pain.

Secondary

MeasureTime frameDescription
Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)12 weeksThe WOMAC was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the WOMAC indicate poorer functional capacity and greater pain and stiffness.
Lequesne Algofunctional Index (LAI)12 weeksThe LAI was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the LAI indicate poorer functional capacity and greater pain and stiffness.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026