HILT Dose Optimization for Knee Osteoarthritis Pain

NCT06916676 | Recruiting

• 1 other identifier: HILT-KOA-DOSE
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change in Knee Pain Intensity

  Visual Analogue Scale (VAS) for Pain: Change from baseline in average knee pain over the past week, measured on a 10 cm horizontal VAS, where 0 cm = no pain and 10 cm = worst imaginable pain. Higher scores indicate worse pain. Minimal Clinically Important Difference (MCID) estimated at 1.25 cm.

  Baseline (T0), Mid-treatment (T1 - after 6 sessions), Post-treatment (T2 - after 12 sessions), 3-month Follow-up (T3)

• Change in Knee Osteoarthritis Symptoms and Function

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change from baseline in the total WOMAC score (Likert scale version 3.1). The WOMAC assesses pain (5 items), stiffness (2 items), and physical function (17 items). Total score ranges from 0-96, with higher scores indicating worse symptoms/function.

  Baseline (T0), Mid-treatment (T1), Post-treatment (T2), 3-month Follow-up (T3)

Secondary Outcomes (3)

• Change in Knee Range of Motion (Flexion and Extension)

  Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)

• Change in Functional Mobility

  Baseline (T0), Post-treatment (T2), 3-month Follow-up (T3)

• Incidence of Adverse Events

  Throughout study participation (up to 3-month follow-up)

Study Arms (4)

Low-Dose HILT (10 J/cm²)

EXPERIMENTAL

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).

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

Medium-Dose HILT (15 J/cm²)

EXPERIMENTAL

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).

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

High-Dose HILT (20 J/cm²)

EXPERIMENTAL

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).

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

Sham HILT

SHAM COMPARATOR

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).

Device: Sham High-Intensity Laser Therapy

Interventions

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

Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 10 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.

Low-Dose HILT (10 J/cm²)

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

Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 15 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.

Medium-Dose HILT (15 J/cm²)

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

Application of HILT using an Nd:YAG laser (BTL-6000, 1064 nm). Delivered via continuous scanning technique (1 cm distance) to 5 zones (25 cm² each) covering anterior, medial, and lateral knee aspects. Target dose: 20 J/cm² per zone. Session frequency: 3x/week for 4 weeks (12 total). Session duration: 15-20 min. Administered by trained PTs in outpatient rehab. Skin temperature monitored.

High-Dose HILT (20 J/cm²)

Sham High-Intensity Laser Therapy DEVICE

Sham procedure mimicking active HILT using the same Nd:YAG laser device (BTL-6000). Same setup, patient positioning, scanning technique over identical zones, and session duration/frequency (3x/week, 4 weeks, 15-20 min). Device powered on with visual/auditory cues active, but no laser energy emitted. Administered by trained PTs in outpatient rehab. Skin temperature monitored.

Sham HILT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Hayah University In Cairo: lead

Study Sites (1)

Faculty of Physical Therapy, Al Hayah University

Cairo, 12311, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Ibrahim Zoheiry, Ph.D

CONTACT

01277774949; ibrahim.alzoheiry@hotmail.com

Mohamed ElMeligie, Ph.D

CONTACT

01159880001; mohamed.elmeligie@ahuc.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)