Clinical Trial: High- versus Low-Level Laser Therapy Combined with Exercise Elicits Outcome- and Population-Specific Responses in Knee Osteoarthritis and Healthy Older Adults (Japan)

Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063107) titled 'High- versus Low-Level Laser Therapy Combined with Exercise Elicits Outcome- and Population-Specific Responses in Knee Osteoarthritis and Healthy Older Adults' on Sept. 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Qufu Normal University

Condition: Condition - Knee osteoarthritis (KOA) and healthy older adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the effects of high-intensity laser therapy (HILT) and low-level laser therapy (LLLT), combined with the same standardized exercise program, on muscle stiffness, muscle co-activation, balance, and pain-related outcomes in individuals with knee osteoarthritis and healthy older adults, and to determine whether treatment responses differ between the two populations. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - High-intensity laser therapy (HILT) combined with standardized functional exercise. HILT was delivered using a 1064-nm laser at five predefined muscle sites (rectus femoris, vastus medialis, vastus lateralis, biceps femoris, and semimembranosus). Each session lasted 30 minutes, with approximately 8970 J delivered per session. Laser treatment was administered three times per week for 12 weeks (36 sessions). Participants also received the same standardized functional exercise program once weekly for 12 weeks. Interventions/Control_2 - Low-level laser therapy (LLLT) combined with standardized functional exercise. LLLT was delivered using an 830-nm laser at the same five predefined muscle sites. Each session lasted 30 minutes, with approximately 717.6 J delivered per session. Laser treatment was administered three times per week for 12 weeks (36 sessions). Participants also received the same standardized functional exercise program once weekly for 12 weeks.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - Healthy older adults: 1. Aged 65-75 years. 2. Able to walk independently on level ground and negotiate stairs, with normal knee flexion and extension. 3. No history of hip, knee, or ankle pain, surgery, or trauma within the previous 6 months. 4. Willing to participate voluntarily and able to provide written informed consent.

Participants with knee osteoarthritis (KOA): 1. Aged 65-75 years and community-dwelling. 2. Diagnosed with KOA according to the American College of Rheumatology (ACR) criteria. 3. Radiographic KOA classified as Kellgren-Lawrence grade II-III. 4. KOA symptoms lasting more than 3 months. 5. Medically stable, without severe systemic or major organ disease. 6. No visual or language comprehension impairment preventing understanding of study instructions. 7. Able to stand independently and walk at least 10 m, with or without an assistive device. 8. Independent in basic activities of daily living. 9. Able and willing to provide written informed consent. Key exclusion criteria - For all participants: 1. Major neurological, musculoskeletal, cardiovascular, cerebrovascular, or psychiatric disorders that could interfere with participation or outcome assessment. 2. Severe systemic or major organ disease, or other medical conditions contraindicating exercise or preventing completion of the study procedures. 3. Inability to cooperate with or complete the intervention or assessment procedures. 4. Inability to provide informed consent. 5. Known allergy or intolerance to surface EMG electrodes. Additional exclusion criteria for participants with KOA: 6. Failure to meet the diagnostic criteria for KOA. 7. Severe lumbar disc herniation or other serious musculoskeletal conditions affecting lower-limb function. 8. Uncontrolled hypertension or diabetes. 9. Use of beta-blockers associated with exercise intolerance. 10. Recent smoking or alcohol abuse. 11. Inability to perform the required exercise tasks, including maintaining a low-level squat. 12. Severe visual impairment or visual-field defects that could interfere with testing. Target Size - 150

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 06 Month 01 Day Date of IRB - 2024 Year 06 Month 01 Day Anticipated trial start date - 2025 Year 01 Month 15 Day Last follow-up date - 2025 Year 06 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072231

Disclaimer: Curated by HT Syndication.