Clinical trial NCT06549543: High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: high-intensity laser
rehabilitation
pain
osteoarthritis
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Visual Analog Scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)
timeFrame: 12 weeks
measure: Lequesne Algofunctional Index (LAI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yüreğir
country: Turkey
facility: Başkent University Faculty of Medicine
state: Adana
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.