Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06916676

HILT Dose Optimization for Knee Osteoarthritis Pain

Led by Al Hayah University In Cairo · Updated on 2025-04-08

140

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HILT Dose Optimization for Knee Osteoarthritis Pain

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 45 and 75 years, inclusive
  • Clinical diagnosis of knee osteoarthritis according to American College of Rheumatology criteria
  • Radiographic evidence of knee osteoarthritis corresponding to Kellgren-Lawrence grade II or III in the target knee
  • Average knee pain intensity 4 or higher on a 10-cm Visual Analogue Scale 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
Not Eligible

You will not qualify if you...

  • Previous surgery on the index knee, including arthroscopy within the last year or joint replacement
  • Diagnosis of inflammatory arthritis such as rheumatoid arthritis, psoriatic arthritis, or gout
  • Intra-articular corticosteroid or hyaluronic acid injection in the index knee within the last 3 months
  • Clinically significant comorbidities that may interfere with participation or assessment, such as severe uncontrolled cardiovascular or pulmonary disease, or significant neurological deficits affecting the lower limb
  • Presence of skin conditions in the treatment area, including infection, open wounds, eczema, or photosensitivity disorders
  • Current use of anticoagulant medication unless stable and cleared by a physician
  • 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

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Trial Site Locations

Total: 1 location

1

Faculty of Physical Therapy, Al Hayah University

Cairo, Egypt, 12311

Actively Recruiting

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Research Team

I

Ibrahim Zoheiry, Ph.D

CONTACT

M

Mohamed ElMeligie, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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