Osteoarthritis, Knee
Conditions
Keywords
Early Symptomatic Knee Osteoarthritis, High-Intensity Laser Therapy, Exercise Therapy, Sham-Controlled Trial
Brief summary
This randomized, double-blind, sham-controlled clinical trial evaluated the effectiveness of high-intensity laser therapy (HILT) in patients with early-stage symptomatic knee osteoarthritis. A total of 39 participants were randomly assigned to receive either HILT combined with a standardized home exercise program or sham laser therapy combined with the same exercise program. Laser or sham treatment was administered over 10 weekday sessions during a two-week period. Participants were assessed at baseline, immediately after treatment, and at the three-month follow-up. Assessments included pain intensity, physical function, health-related quality of life, walking performance, knee range of motion, and muscle strength. The aim was to determine whether adding HILT to exercise provides additional clinical benefits compared with sham laser therapy combined with exercise.
Interventions
DEVICESham Laser Therapy
Sham laser therapy was administered using the same treatment schedule and application procedure as the active HILT group, but without delivering therapeutic laser energy. Participants received 10 sham sessions over two consecutive weeks (five sessions per week), combined with the same standardized home exercise program.
High-intensity laser therapy (HILT) was administered using a 1064-nm laser at a frequency of 20 Hz, with an energy density of 1530 mJ/cm² and a total energy of 3000 J per session. Treatment consisted of 10 sessions administered on consecutive weekdays over a two-week period. HILT was combined with a standardized home exercise program.
Both groups received the same standardized home exercise program, including knee range-of-motion exercises (3 sets of 10-12 repetitions), static stretching exercises (3 repetitions with a 30-second hold), and isometric and isotonic strengthening exercises (3 sets of 10-12 repetitions). The exercise program was prescribed as a home-based intervention alongside the assigned laser or sham laser treatment.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Patients presenting to the Physical Medicine and Rehabilitation outpatient clinics of Ege University Faculty of Medicine Hospital with knee pain lasting no longer than 6 months and a Visual Analog Scale (VAS) pain score of at least 4. 2. Availability of bilateral weight-bearing knee radiographs in two views obtained within the preceding 6 months. 3. Diagnosis of early symptomatic knee osteoarthritis according to the Italian Society of Rheumatology International Initiative (ESKOA) criteria. 4. Ability to cooperate with the prescribed exercise program. 5. Willingness to participate in the study and provision of informed consent. 6. Age eligibility: * 40-49 years: Presence of at least one of the following risk factors for early symptomatic knee osteoarthritis. * 50-75 years: Eligible regardless of the presence of the listed risk factors. Risk factors: * Body mass index (BMI) greater than 25 kg/m². * Family history of knee osteoarthritis. * Previous knee injury. * Lower-limb alignment abnormality. * Lower-limb length discrepancy. * Osteoarthritis at other anatomical sites. * Metabolic syndrome. * Difficulty initiating brisk walking or running after a period of inactivity.
Exclusion criteria
1. Receipt of an intra-articular knee injection or physical therapy within the preceding 6 months, or use of natural health products such as glucosamine or chondroitin. 2. History of knee surgery. 3. Presence of inflammatory arthritis, including rheumatoid arthritis, psoriatic arthritis, or gouty arthritis. 4. History of trauma within the preceding 6 months. 5. Fixed knee flexion deformity greater than 10 degrees or varus/valgus deformity greater than 15 degrees. 6. Referred pain originating from the lumbar spine or hip. 7. Neurological deficits affecting the lower extremities. 8. Medical conditions that could prevent participation in the exercise program or completion of the study, including: * Myocardial infarction or cerebrovascular event within the preceding 3 months. * Congestive heart failure. * Severe chronic obstructive pulmonary disease. * History of myocardial ischemia during treadmill testing. * History of arterial or venous circulatory disorders. 9. Presence of a cardiac pacemaker or metal implants. 10. Pregnancy. 11. History of malignancy, knee osteonecrosis, infectious disease, psychiatric illness, or bleeding diathesis. 12. Epilepsy. 13. Conditions impairing cooperation or communication, including language barriers, aphasia, marked affective disorders, or a history of severe psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Assessed by Visual Analog Scale (VAS) | Baseline, immediately after the 2-week treatment period, and 3 months after baseline | Pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. |
| Knee Symptoms and Physical Function Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline, immediately after the 2-week treatment period, and 3 months after baseline | Knee osteoarthritis-related symptoms and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including pain, stiffness, and physical function subscales. Higher scores indicate greater symptom severity and functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status Assessed by Health Assessment Questionnaire (HAQ) | Baseline, immediately after the 2-week treatment period, and 3 months after baseline | Functional status and activities of daily living were assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI). Scores range from 0 to 3, with higher scores indicating greater disability and poorer functional status. |
| Health-Related Quality of Life Assessed by Short Form Health Survey (SF-12) Physical Component Summary (PCS) | Baseline, immediately after the 2-week treatment period, and 3 months after baseline | Physical health-related quality of life was assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better physical health-related quality of life. |
| Health-Related Quality of Life Assessed by Short Form Health Survey (SF-12) Mental Component Summary (MCS) | Baseline, immediately after the 2-week treatment period, and 3 months after baseline | Mental health-related quality of life was assessed using the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12). Higher scores indicate better mental health-related quality of life. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORA.Simin Hepgüler, MD
Ege University
Outcome results
None listed