High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

NCT06549543 | Completed DMC

• 1 other identifier: KA22/129
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Keywords

high-intensity laser; rehabilitation; pain; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Visual Analog Scale (VAS)

  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 Outcomes (2)

• Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)

  12 weeks

• Lequesne Algofunctional Index (LAI)

  12 weeks

Study Arms (2)

High-Intensity Laser Therapy

EXPERIMENTAL

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; Other: Transcutaneous Electrical Nerve Stimulation; Other: Hotpacks

Control

SHAM COMPARATOR

This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions.

Other: Transcutaneous Electrical Nerve Stimulation; Other: Hotpacks; Other: SHAM - High Intensity Laser Therapy

Interventions

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.

High-Intensity Laser Therapy

Transcutaneous Electrical Nerve Stimulation OTHER

TENS is an analgesic modality of physical therapy

Control; High-Intensity Laser Therapy

Hotpacks OTHER

Hotpacks is a thermoanalgesia modality of physical therapy

Control; High-Intensity Laser Therapy

SHAM - High Intensity Laser Therapy OTHER

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

Control

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Başkent University Faculty of Medicine

Yüreğir, Adana, 01060, Turkey (Türkiye)

Location

Related Publications (4)

• Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.

  PMID: 33074393 BACKGROUND

• Ekici B, Ordahan B. Evaluation of the effect of high-intensity laser therapy (HILT) on function, muscle strength, range of motion, pain level, and femoral cartilage thickness in knee osteoarthritis: randomized controlled study. Lasers Med Sci. 2023 Sep 25;38(1):218. doi: 10.1007/s10103-023-03887-y.

  PMID: 37743421 BACKGROUND

• Hardie EM, Carlson CS, Richardson DC. Effect of Nd:YAG laser energy on articular cartilage healing in the dog. Lasers Surg Med. 1989;9(6):595-601. doi: 10.1002/lsm.1900090610.

  PMID: 2601554 BACKGROUND

• Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.

  PMID: 34654554 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the participants, investigators and outcomes assessors were blinded throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 12, 2024
• Study Start: April 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: February 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)