Tokyo, Jan. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060248) titled 'Comparison of High- and Low-Energy Laser Therapy in Patients with Knee Osteoarthritis' on Jan. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Qufu Normal University, Qufu, Shandong, China

Condition: Condition - Knee osteoarthritis (KOA) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to compare the clinical effectiveness of high-energy laser therapy and low-energy laser therapy in individuals with knee osteoarthritis.

Secondary objectives include comparing their effects on neuromuscular function, including muscle stiffness, muscle co-activation, and balance control, as well as exploring the clinical applicability of high-energy laser therapy as a non-invasive physical treatment approach. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will receive high energy laser therapy targeting the painful knee region. The intervention will be delivered using a high energy laser device with a maximum output power of up to 30 W, employing combined multi wavelength laser emission. Treatment will be administered in continuous or pulsed modes, with pulse duty cycles adjustable between 1% and 99%, according to individual tolerance. A rolling massage style applicator with a treatment depth of >=15 mm will be used to address deep pain and inflammatory tissues. Each session will be conducted under standardized parameters for treatment duration and frequency, consistent with the study protocol. Interventions/Control_2 - Participants will receive low-level laser therapy applied to the same knee region. The intervention will be delivered using a conventional low-level laser device with substantially lower output power than the high-energy laser. Treatment will be administered in accordance with established low-level laser therapy parameters, including fixed wavelength, power density, and exposure duration. Sessions will be matched in frequency and overall treatment period to the high-energy laser group.

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - Adults aged 50 to 75 years.

Clinical diagnosis of knee osteoarthritis according to established criteria (e.g., American College of Rheumatology criteria).

Presence of chronic knee pain for at least 3 months, with a pain intensity >= 40 mm on a 0 to 100 mm Visual Analogue Scale (VAS) at baseline.

Radiographic evidence of knee osteoarthritis classified as Kellgren Lawrence grade II to III.

Ability to walk independently without assistive devices.

No participation in other physical therapy, laser therapy, or injection treatments for knee pain within the previous 3 months.

Willingness to comply with the intervention protocol and assessment schedule.

Provision of written informed consent prior to participation. Key exclusion criteria - Prior knee surgery, knee replacement, or major lower limb surgery within the past 12 months.

Inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic musculoskeletal or neurological disorders affecting lower limb function.

Severe knee osteoarthritis (Kellgren Lawrence grade IV).

Intra-articular injection, systemic corticosteroid use, or physical therapy for knee pain within the previous 3 months.

Contraindications to laser therapy, including malignancy, photosensitivity disorders, pregnancy, or implanted electronic medical devices.

Skin infection, open wound, or dermatological conditions at the treatment site.

Inability to comply with the intervention protocol or outcome assessments. Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 04 Month 01 Day Date of IRB - 2025 Year 04 Month 01 Day Anticipated trial start date - 2024 Year 06 Month 01 Day Last follow-up date - 2025 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068909

Disclaimer: Curated by HT Syndication.