High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Transcutaneous Electrical Nerve Stimulation; Other: High Intensity Laser Therapy; Other: SHAM - High Intensity Laser Therapy; Other: Hotpacks

• Registration Number: NCT06549543
• Lead Sponsor: Baskent University

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	SHAM - High Intensity Laser Therapy	This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions.
Control	Transcutaneous Electrical Nerve Stimulation	This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions.
High-Intensity Laser Therapy	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.
High-Intensity Laser Therapy	Transcutaneous Electrical Nerve Stimulation	This group (n = 21) received transcutaneous electrical nerve stimulation (TENS), hotpack (HP), exercises, and high-intensity laser therapy (HILT) for 10 consecutive sessions.
High-Intensity Laser Therapy	Hotpacks	This group (n = 21) received transcutaneous electrical nerve stimulation (TENS), hotpack (HP), exercises, and high-intensity laser therapy (HILT) for 10 consecutive sessions.
Control	Hotpacks	This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions.

Primary Outcome Measures

Name	Time	Method
The Visual Analog Scale (VAS)	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 Outcome Measures

Name	Time	Method
Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)	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.
Lequesne Algofunctional Index (LAI)	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.

Trial Locations

Locations (1)

Başkent University Faculty of Medicine; 🇹🇷 Yüreğir, Adana, Turkey