Knee Osteoarthritis Rehab: High-Intensity Laser vs Classical Modalities (HILT-CM (KOA))

Rehabilitation of Knee Osteoarthritis by High Intensity Laser Therapy vs Classical Modalities

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthritis Osteoarthritis
• Intervention / Treatment: Device: High-Intensity Laser Therapy (HILT); Device: Conventional Physical Therapy Modalities

Detailed Description

Knee Osteoarthritis is a chronic degenerative joint disorder characterized by progressive cartilage loss, pain, stiffness, and functional limitation. It is a leading cause of disability, particularly among older adults, and its prevalence is increasing with population aging.

Non-surgical management is the first-line approach and includes exercise therapy and physical modalities aimed at reducing pain and improving joint function. High-Intensity Laser Therapy is a non-invasive modality that delivers high-energy light to tissues, promoting cellular activity, increasing adenosine triphosphate (ATP) production, enhancing microcirculation, and reducing inflammation and edema. In contrast, Low-Level Laser Therapy has been more extensively studied, while evidence regarding HILT remains limited.

This study is a randomized comparative trial designed to evaluate the efficacy and safety of HILT compared with conventional physical therapy modalities in patients with knee osteoarthritis. A total of 100 participants meeting the American College of Rheumatology criteria will be recruited from rheumatology and rehabilitation centers in Erbil, Iraq. Participants will be randomly assigned to one of two groups: (1) HILT combined with therapeutic exercise, or (2) conventional physical therapy modalities combined with therapeutic exercise.

The primary outcome is pain intensity at 4 weeks, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale or Visual Analogue Scale (VAS). Secondary outcomes include pain at 8 weeks and functional status. Structural joint changes will be evaluated using magnetic resonance imaging (MRI), including assessment of cartilage thickness, joint irregularity, effusion, and osteophyte formation.

Laboratory assessments will be conducted before and after intervention to evaluate biological effects. These include inflammatory markers (C-reactive protein), gene expression markers related to cartilage metabolism (TGFB1, FOXO1, COMP, and MMP3) measured by RT-PCR, and oxidative stress markers (malondialdehyde [MDA] and superoxide dismutase [SOD]) measured using ELISA.

Eligible participants are adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis who are able to provide informed consent and comply with study procedures. Exclusion criteria include contraindications to laser therapy (e.g., malignancy, epilepsy, photosensitivity, or local infection), recent knee surgery, advanced osteoarthritis requiring surgical intervention, pregnancy or lactation, and severe comorbid conditions that may affect participation or outcomes.

Data will be analyzed using Statistical Package for the Social Sciences (SPSS, version 21). Ethical approval will be obtained from the relevant institutional review bodies, and written informed consent will be obtained from all participants. Confidentiality will be maintained throughout the study.

This study aims to determine whether HILT provides superior clinical and biological outcomes compared with conventional physical therapy modalities in the management of knee osteoarthritis.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahdi Qadir, PhD; Phone Number: +9647504631542; Email: mahdiqader@epu.edu.iq
• Study Contact Backup: Name: Shukur Smail, PhD; Phone Number: 07504631542; Email: shukur.smail@gmail.com

Study Locations

• Iraq
  • Erbil Governorate
    • Erbil, Erbil Governorate, Iraq, 44001
      • Recruiting
      • Aylan Center
      • Contact: Mahdi Qadir, PhD; Phone Number: 07504631542; Email: mahdiqader@epu.edu.iq
      • Contact: Ahmed bapir, PhD; Phone Number: 07507580043; Email: ahmed.bapir@gmail.com
      • Principal Investigator: Mahdi Qadir, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (HILT); 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); 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; Other Names: High Power Laser Therapy; Class IV Laser Therapy; Device: Conventional Physical Therapy Modalities; 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.; Other Names: Transcutaneous Electrical Nerve Stimulation (TENS); Therapeutic Ultrasound; Microwave diathermy; Deep heat Therapy
Active Comparator: Classical Modalities; 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); 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; Other Names: High Power Laser Therapy; Class IV Laser Therapy; Device: Conventional Physical Therapy Modalities; 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.; Other Names: Transcutaneous Electrical Nerve Stimulation (TENS); Therapeutic Ultrasound; Microwave diathermy; Deep heat Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity (Visual Analog Scale - VAS)	Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS) for global pain or walking pain. Patients mark their pain level on a 100 mm line where 0 represents "no pain" and 100 represents "worst pain imaginable."	Baseline to 4 weeks post-treatment initiation

Collaborators and Investigators

• Sponsor: Erbil Polytechnic University
• Investigators: Study Director: Ahmed Bapir, PhD, EPU

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LASER; knee OA; classical modalities
• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Diathermy; Hyperthermia, Induced; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation; Ultrasonic Therapy
• Other Study ID Numbers: Erbil Polytechnic University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly. This decision is based on: (1) protection of participant privacy and confidentiality in accordance with Iraqi health research regulations and institutional ethical guidelines; (2) the need to protect data integrity for ongoing PhD thesis completion and future publications; (3) local institutional policies regarding data sharing. De-identified summary data may be available from the principal investigator upon reasonable request and with appropriate data use agreements after completion of the PhD program and primary publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No