High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

August 9, 2024 updated by: Selen Özgözen, Baskent University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Adana
      • Yüreğir, Adana, Turkey, 01060
        • Başkent University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Intensity Laser Therapy
This group (n = 21) received transcutaneous electrical nerve stimulation (TENS), hotpack (HP), exercises, and high-intensity laser therapy (HILT) for 10 consecutive sessions.
Other: High 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.
Other: Transcutaneous Electrical Nerve Stimulation
TENS is an analgesic modality of physical therapy
Other: Hotpacks
Hotpacks is a thermoanalgesia modality of physical therapy
Sham Comparator: Control
This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions.
Other: Transcutaneous Electrical Nerve Stimulation
TENS is an analgesic modality of physical therapy
Other: SHAM - High Intensity Laser Therapy
for control group, sham HILT was applied, with lights on but no laser beam
Other: Hotpacks
Hotpacks is a thermoanalgesia modality of physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

August 2, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA22/129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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