Knee Osteoarthritis Rehab: High-Intensity Laser vs Classical Modalities

NCT07551245 | Recruiting

• 1 other identifier: Erbil Polytechnic University
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness and safety of High-Intensity Laser Therapy (HILT) with conventional physical therapy treatments in patients with knee osteoarthritis. Knee osteoarthritis is a common condition, especially in older adults, causing pain, stiffness, reduced movement, and difficulty performing daily activities. Current treatments focus on reducing pain and improving joint function. In this study, 100 patients with knee osteoarthritis will be divided into two groups. One group will receive HILT combined with therapeutic exercises, while the other group will receive conventional physical therapy modalities along with the same exercises. The treatment outcomes will be evaluated over time. The main outcomes include pain reduction (measured by pain scales such as WOMAC and VAS), improvement in joint function, and structural changes in the knee assessed by MRI. In addition, laboratory tests will be used to measure inflammation, cartilage health markers, and oxidative stress before and after treatment. The goal is to determine whether HILT provides better pain relief, improves joint function, and is safe compared to standard therapy. The results may help improve rehabilitation strategies for patients with knee osteoarthritis.

Conditions

Knee Arthritis Osteoarthritis

Keywords

LASER; knee OA; classical modalities

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (WOMAC Pain Subscale)

  Pain intensity will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The WOMAC is a validated instrument that measures pain, stiffness, and physical function in patients with osteoarthritis. The pain subscale consists of 5 items scored on a 0-10 scale, with higher scores indicating more severe pain.

  Baseline to 4 weeks post-treatment initiation

Secondary Outcomes (1)

• Change in Pain Intensity (Visual Analog Scale - VAS)

  Baseline to 4 weeks post-treatment initiation

Study Arms (2)

Experimental Group (HILT)

EXPERIMENTAL

Patients will receive High-Intensity Laser Therapy (HILT) combined with a standardized therapeutic exercise program. HILT parameters include four-wavelength beam, continuous/modulating frequencies, and SuperPulse mode for deep penetration.

Device: High-Intensity Laser Therapy (HILT); Device: Conventional Physical Therapy Modalities

Classical Modalities

ACTIVE COMPARATOR

Patients will receive classical physical modalities (such as therapeutic ultrasound or TENS, as per standard local practice) combined with the same standardized therapeutic exercise program.

Device: High-Intensity Laser Therapy (HILT); Device: Conventional Physical Therapy Modalities

Interventions

High-Intensity Laser Therapy (HILT) DEVICE

High-Intensity Laser Therapy (HILT) combined with therapeutic exercise program. HILT Specifications: * Four-wavelength beam system for deep tissue penetration * Continuous and modulating frequencies to promote pain control and healing * SuperPulse mode for deeper therapeutic penetration * High power output delivering larger doses with shorter treatment times * Pre-programmed presets for consistent and safe treatment outcomes Mechanism of Action: HILT delivers high energy output into tissues, generating photochemical effects including: * Increased mitochondrial oxidation and ATP production * Enhanced blood circulation and metabolism * Fast absorption of edema and removal of exudates * Increased serotonin and endorphin levels * Anti-inflammatory effects through reduced prostaglandin synthesis * Decreased nerve cell membrane permeability for Na/K causing hyperpolarization * Increased lymphatic flow * Modulation of genetic markers: increased expression of cartilage protection biomarkers

Also known as: High Power Laser Therapy, Class IV Laser Therapy

Classical Modalities; Experimental Group (HILT)

Conventional Physical Therapy Modalities DEVICE

Classical Physical Modalities combined with therapeutic exercise program. Modalities Include: * Therapeutic Ultrasound and/or other conventional physical therapy modalities as per standard clinical practice for knee osteoarthritis * Evidence-based parameters for knee OA treatment Treatment Protocol: * Duration: 8 weeks * Combined with the same standardized therapeutic exercise program as the HILT group * Sessions will be conducted at rheumatology and rehabilitation units in Erbil, Iraq This represents the current standard of care for conservative management of knee osteoarthritis in physical medicine and rehabilitation settings.

Also known as: Therapeutic Ultrasound, Microwave diathermy, Transcutaneous Electrical Nerve Stimulation (TENS), Deep heat Therapy

Classical Modalities; Experimental Group (HILT)

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Knee Osteoarthritis: Patients must have a clinical and radiographic diagnosis of knee OA according to the American College of Rheumatology (ACR) criteria, including evidence of joint space narrowing, osteophyte formation, and other degenerative changes observed on X-rays or MRI.
• Age: Adults aged between 40 and 75 years. Willingness to Participate: Participants must provide informed consent and be willing to adhere to the study protocol, including attending all treatment sessions and follow-up assessments.
• Kellgren-Lawrence Grade: Patients with knee OA grades 1-3 (mild to moderate OA).

You may not qualify if:

• Contraindications to Laser Therapy:
• Active malignancy History of epilepsy Photosensitivity disorders Active infection in the treatment area
• Surgical History:
• Patients who have undergone knee surgery within the past 6 months Scheduled surgery during the study period
• Advanced Disease:
• Kellgren-Lawrence Grade 4 (severe OA) where surgical intervention is indicated
• Pregnancy or Lactation:
• Pregnant or lactating women
• Severe Comorbidities:
• Uncontrolled diabetes Severe cardiovascular disease Neurological disorders that might interfere with participation or affect treatment outcomes

Sponsors & Collaborators

• Erbil Polytechnic University: lead

Study Sites (1)

Aylan Center

Erbil, Erbil Governorate, 44001, Iraq

RECRUITING

Related Publications (2)

• 2. Igawa T, Katsuhira J: Biomechanical analysis of stair descent in patients with knee osteoarthritis. J Phys Ther Sci, 2014, 26: 629-631.

  RESULT

• 1. Manetta J, Franz LH, Moon C, et al.: Comparison of hip and knee muscle moments in subjects with and without knee pain. Gait Posture, 2002, 16: 249-254.

  RESULT

MeSH Terms

Interventions

Ultrasonic Therapy; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Ahmed Bapir, PhD

  EPU

  STUDY DIRECTOR

Central Study Contacts

Mahdi Qadir, PhD

CONTACT

+9647504631542; mahdiqader@epu.edu.iq

Shukur Smail, PhD

CONTACT

07504631542; shukur.smail@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A - This is an open-label study with no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This is a randomized, parallel-group, open-label comparative study. Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups using simple randomization. Group 1 will receive High-Intensity Laser Therapy (HILT) plus therapeutic exercise, and Group 2 will receive classical physical modalities (ultrasound/TENS) plus therapeutic exercise. The study is unblinded (open-label) as the nature of the interventions makes blinding of participants and therapists impractical. However, outcome assessors for MRI evaluation will be blinded to group allocation. Treatment duration is 8 weeks with follow-up assessments at baseline, 4 weeks, and 8 weeks.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)