Clinical trial NCT06916676: HILT Dose Optimization for Knee Osteoarthritis Pain
Official title: Optimal High-Intensity Laser Therapy (HILT) Parameters for Pain and Function in Patients With Moderate Knee Osteoarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find the best settings (dose) for High-Intensity Laser Therapy (HILT) to reduce pain and improve function in people with moderate knee osteoarthritis. Participants will be randomly assigned to receive one of three different doses of HILT (low, medium, or high) or a sham (placebo) laser treatment, three times a week for four weeks. The main outcomes measured will be changes in knee pain (using a pain scale) and knee function (using a questionnaire) from the beginning to the end of the 4-week treatment period.


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.

Primary outcomes:
measure: Change in Knee Pain Intensity
timeFrame: Baseline (T0), Mid-treatment (T1 - after 6 sessions), Post-treatment (T2 - after 12 sessions), 3-month Follow-up (T3)
measure: Change in Knee Osteoarthritis Symptoms and Function
timeFrame: Baseline (T0), Mid-treatment (T1), Post-treatment (T2), 3-month Follow-up (T3)
Secondary outcomes:
measure: Change in Knee Range of Motion (Flexion and Extension)
timeFrame: Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
measure: Change in Functional Mobility
timeFrame: Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)
measure: Incidence of Adverse Events
timeFrame: Throughout study participation (up to 3-month follow-up)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References: