Optimizing laser therapy doses for knee osteoarthritis pain relief

Optimal High-Intensity Laser Therapy (HILT) Parameters for Pain and Function in Patients With Moderate Knee Osteoarthritis: A Randomized Controlled Trial

This study is testing different doses of laser therapy to see which one helps people aged 45 to 75 with knee osteoarthritis feel less pain and move better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Al Hayah University In Cairo (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06916676 on ClinicalTrials.gov

What this trial studies

This study aims to determine the most effective doses of High-Intensity Laser Therapy (HILT) for alleviating pain and enhancing function in individuals suffering from moderate knee osteoarthritis. Participants aged 45 to 75 will be randomly assigned to receive one of three different doses of HILT or a placebo treatment, administered three times a week over four weeks. The primary outcomes will focus on changes in knee pain levels and functional ability, assessed through a pain scale and a questionnaire. This approach seeks to identify the optimal therapeutic dose for improved patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 45 to 75 with a clinical diagnosis of knee osteoarthritis and moderate pain levels.

Not a fit: Patients with inflammatory arthritis or those who have had recent knee surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive treatment option that significantly reduces knee pain and improves function for patients with osteoarthritis.

How similar studies have performed: While there is ongoing research into laser therapies for pain management, this specific dose optimization approach is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Age between 45 and 75 years, inclusive. Clinical diagnosis of knee osteoarthritis according to American College of Rheumatology (ACR) criteria (knee pain plus at least 3 of 6: age \>50, morning stiffness \<30 min, crepitus, bony tenderness, bony enlargement, no palpable warmth).

Radiographic evidence of knee osteoarthritis corresponding to Kellgren-Lawrence grade II or III in the target knee.

Average knee pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) during weight-bearing activities in the past week.

Willingness and ability to attend 3 sessions per week for 4 weeks and attend all assessment sessions.

Exclusion Criteria:

Previous surgery on the index knee (including arthroscopy within the last year or joint replacement).

Diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, gout).

Intra-articular corticosteroid or hyaluronic acid injection in the index knee within the last 3 months.

Clinically significant comorbidities that could interfere with participation or assessment (e.g., severe uncontrolled cardiovascular disease, severe pulmonary disease, significant neurological deficits affecting the lower limb).

Presence of skin conditions (e.g., infection, open wounds, eczema, photosensitivity disorders) in the area designated for laser treatment.

Current use of anticoagulant medication (e.g., warfarin, DOACs) due to potential risk, unless stable and cleared by physician. (Consider if this is truly necessary based on HILT mechanism).

History of cancer in the treatment area or active malignancy elsewhere. Known photosensitivity or use of photosensitizing medications. Pregnancy, planning pregnancy, or breastfeeding. Participation in another interventional clinical trial within the last 30 days. Inability to understand or communicate in the study language.

Where this trial is running

Cairo

• Faculty of Physical Therapy, Al Hayah University — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Ibrahim Zoheiry, Ph.D

Conditions Knee Osteoarthritis