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Taking people in EgyptNo phase

HILT Dose Optimization for Knee Osteoarthritis Pain

Key facts

Who runs it
Al Hayah University In Cairo
Where
Cairo, EgyptSee the site
Trial code
Status
Recruiting
People taking part
140 people, planned
Started
23 Apr 2025
Expected to end
1 Jun 2027
Type of study
Interventional, 4 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Low-Dose High-Intensity Laser Therapy (10 J/cm²)
  • Medium-Dose High-Intensity Laser Therapy (15 J/cm²)
  • High-Dose High-Intensity Laser Therapy (20 J/cm²)
  • Sham High-Intensity Laser Therapy
Record updated
8 April 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous surgery on the index knee (including arthroscopy within the last year or joint replacement)
  • Intra-articular corticosteroid or hyaluronic acid injection in the index knee within the last 3 months
  • 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)
  • 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
  • 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
  • Diagnosis of inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis, gout)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Egypt

  • Faculty of Physical Therapy, Al Hayah UniversityCairo, EgyptContact: Mohamed ElMeligie, Ph.DTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Low-Dose HILT (10 J/cm²)Treatment being tested

    Participants receive High-Intensity Laser Therapy at a dosage of 10 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).

    Treatment: Low-Dose High-Intensity Laser Therapy (10 J/cm²)

  • Medium-Dose HILT (15 J/cm²)Treatment being tested

    Participants receive High-Intensity Laser Therapy at a dosage of 15 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).

    Treatment: Medium-Dose High-Intensity Laser Therapy (15 J/cm²)

  • High-Dose HILT (20 J/cm²)Treatment being tested

    Participants receive High-Intensity Laser Therapy at a dosage of 20 J/cm² per treatment zone, 3 times per week for 4 weeks (12 sessions total).

    Treatment: High-Dose High-Intensity Laser Therapy (20 J/cm²)

  • Sham HILTSham treatment, for comparison

    Participants receive a sham High-Intensity Laser Therapy procedure using the same device and application technique, but with no energy delivered, 3 times per week for 4 weeks (12 sessions total).

    Treatment: Sham High-Intensity Laser Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Optimal High-Intensity Laser Therapy (HILT) Parameters for Pain and Function in Patients With Moderate Knee Osteoarthritis: A Randomized Controlled Trial
Fit questions
Built from NCT06916676, who can take part
Record updated
8 April 2025