Comparison of the Effectiveness of High-Intensity and Low-Intensity Laser Therapies in Primary Knee Osteoarthritis

Our primary goal is to investigate the advantages of low-intensity laser therapy (LLLT) and high-intensity laser therapy (HILT) over conventional therapy in patients with knee osteoarthritis (OA), our secondary goal is to investigate the advantages of HILT and LLLT; to compare its analgesic effects, its effects on functional status and quality of life, and its effects on femoral cartilage thickness.

Study Overview

• Status: Completed
• Conditions: Primary Knee Osteoarthritis
• Intervention / Treatment: Device: Conventional Treatment; Device: conventional treatment and high-intensity laser therapy(HILT); Device: conventional treatment and low-intensity laser therapy (LLLT)

Detailed Description

In the study, those who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital outpatient clinic between 01.10.2020-01.10.2021, were between the ages of 55-75, were diagnosed with primary knee OA according to the American Rheumatology Association, stage 2-3 knee according to Kellgren and Lawrence radiological classification. with OA; 72 volunteer patients with knee pain with a visual pain score of 4 and above for at least 3 months were included. The study was designed as a prospective, randomized, controlled, single-center. Patients were randomly divided into 3 treatment groups. Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients in the first group, conventional treatment and HILT were applied to 24 patients in the second group, and conventional treatment and LLLT were applied to 24 patients in the third group. All groups were evaluated clinically and ultrasonographically at the beginning of the treatment, at the end of the treatment and at the 3rd month after the treatment.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bilkent-Cankaya
    • Ankara, Bilkent-Cankaya, Turkey, 06800
      • Ankara Bilkent City Hospital Phisical Therapy and Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range of 55-75 years
• Primary knee OA diagnosis according to ACR (American College of Rheumatology) and Knee OA classified as stage 2-3 according to the KL (Kellgren-Lawrence) radiological classification
• Visual pain score of 4 or higher for knee pain lasting for at least 3 months

Exclusion Criteria:

• Patients with secondary knee OA
• Patients who have undergone surgical operations related to the knee joint
• Patients with pathology in the hip and/or ankle on the same side
• Patients who have received intra-articular corticosteroid, hyaluronic acid, or PRP injections in the knee joint in the last 6 months
• Patients who have received physical therapy for the knee region in the last 6 months
• Patients with serious systemic diseases such as malignancy, congestive heart failure, or chronic obstructive pulmonary disease
• Patients with insufficient cognitive function

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional treatment; Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients.	Device: Conventional Treatment; Conventional treatment including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg for 4 weeks, 3 days a week for 4 weeks in 24 patients
Active Comparator: conventional treatment and HILT(high-intensity laser therapy); Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients .	Device: conventional treatment and high-intensity laser therapy(HILT); Conventional treatment and HILT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and HILT for 4 weeks, 3 days a week for 4 weeks in 24 patients .
Active Comparator: conventional treatment and LLLT(low-intensity laser therapy); Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients.	Device: conventional treatment and low-intensity laser therapy (LLLT); Conventional treatment and LLLT including hotpack therapy, Transcutaneous Electrical Nerve Stimulation (TENS), joint range of motion exercises, straight leg lifting exercises, quadriceps strengthening exercises, pillow squeezing exercises, balance exercises on one leg and LLLT for 4 weeks, 3 days a week for 4 weeks in 24 patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	In the clinical evaluation, the range of motion of the patients in the affected extremity was determined by goniometry	Baseline, after 1 month and 3 month changes
visual pain score (VAS)	In the clinical evaluation, the pain score with movement and resting was determined by visual pain score (VAS).The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.	Baseline, after 1 month and 3 month changes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Western Ontario and McMaster Universities (WOMAC) index is the most common used clinical tools for evaluating patients with knee OA.It is consisted of 33 items which evaluates the health and function of the patient from various aspects including: clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions). Each question has five subscales where best situation scores as never or none and the worst one names as extreme or always. Here, higher scores are representative of better situation and less pain.	Baseline, after 1 month and 3 month changes
Lequesne Index	The Lequesne index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living . The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability	Baseline, after 1 month and 3 month changes
Short form SF-36 scale	The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions.	Baseline, after 1 month and 3 month changes
Femoral cartilage thickness	The femoral cartilage thickness measurements of the patients participating in the study were performed using a Logiq 9 (GE Medical Systems®) ultrasound device with a linear probe (7-12 MHz, "ZONARE"). The ultrasonographic measurement was performed in the supine position of the patient, with the knee in maximum flexion, at three different locations: the medial femoral intercondylar region, the median intercondylar region, and the lateral femoral intercondylar region. The probe was placed transversely on the thigh, perpendicular to the bone surface, immediately above the superior corner of the patella. The cartilage thickness was calculated by measuring the hypoechoic distance between the two hyperechoic lines: one showing the soft tissue-cartilage surface and the other showing the cartilage-bone surface. Three measurements were taken for each knee, and the average was calculated.	Baseline, after 1 month and 3 month changes

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: February 8, 2025
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis, Low level light therapy, high level light therapy,Muscle Skeletal; Ultrasonography
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: E1-20-1087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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