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NCT Number: NCT06549543

High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University Faculty of Medicine

Yüreğir, Adana, 01060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High intensity Laser therapy

Other

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.

Transcutaneous Electrical Nerve Stimulation

Other

TENS is an analgesic modality of physical therapy

Hotpacks

Other

Hotpacks is a thermoanalgesia modality of physical therapy

SHAM - High Intensity Laser Therapy

Other

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

Primary outcomes

  1. The Visual Analog Scale (VAS)

    Time frame: 12 weeks

    The 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 outcomes

  1. Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)

    Time frame: 12 weeks

    The 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.

  2. Lequesne Algofunctional Index (LAI)

    Time frame: 12 weeks

    The 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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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