Low-Level Laser Therapy in Knee Osteoarthritis: Effects on Clinical Outcomes, Femoral Cartilage Thickness and Regional Sarcopenia
NCT ID: NCT07078877
Last Updated: 2025-09-16
Study Results
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Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-07-14
2026-07-31
Brief Summary
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In addition to the conventional exercise program, patients in the first group will also receive low-level laser therapy (LLLT). If the laser group is found to be superior at the end of the study, the patients who only received the exercise program will be recalled and administered LLLT. Patients who meet the inclusion criteria will be enrolled in the study.
Sample size calculations were based on data from a previous study by Alghadir et al. Using a mean of 3.25 and a standard deviation of 2.61 for the WOMAC pain subscale, the number of participants was calculated with 95% power and a 5% significance level. As a result, it was determined that at least 29 patients would be included in each group. Written informed consent will be obtained from each patient before enrollment. Randomization will be performed according to the order of patient admissions. Patients will be evaluated before treatment, and at the 1st and 3rd months post-treatment.
The dosage of laser application was selected based on the recommendations of the World Association for Photobiomodulation Therapy (WALT). Patients will be treated 5 sessions per week for 2 weeks. The treatment will be applied using the BTL SMART 4000 laser device at a wavelength of 835 nm and a dose of 10 J/point.
The conventional home based exercise program includes: range of motion (ROM) exercises, stretching, strengthening, relaxation and aerobic exercises. The program will begin with ROM, stretching, relaxation, aerobic, and isometric strengthening exercises. After one week, concentric and eccentric strengthening exercises will be added using elastic bands. The home exercise program will be performed 3 days a week, each exercise in 3 sets of 10 repetitions and 2 minutes of rest between sets. Aerobic walking at a moderate pace for 30 minutes will be recommended. Each patient will be shown and taught the exercises to be performed at home, and will also be provided with illustrated instructions. The home based exercise program will continue for 12 weeks. Patients will be contacted by phone weekly during the first month, and then every two weeks thereafter, to assess their adherence to and continuation of the home based exercise program.
Before starting treatment, demographic information will be collected, medical history will be taken, and a physical examination will be performed. Pre-treatment evaluations include:
* Measurement of height, weight, and calculation of body mass index (BMI)
* Femoral cartilage thickness and quadriceps muscle thickness measurement via ultrasound
* Determination of the Sonographic Thigh Adjustment Ratio (STAR)
* Application of the SARC-F screening test; those scoring over 4 will undergo whole-body muscle mass measurement
* Handgrip strength (HGS) measurement using a Jamar hand dynamometer
* Five-times chair stand test (CST)
* Timed Up and Go (TUG) test
* Six-minute walk test
* Visual Analog Scale (VAS) for pain
* Western Ontario and McMaster Universities Arthritis Index (WOMAC)
* Short Form-36 (SF-36) quality of life questionnaire
Post-treatment evaluations (At the end of the 1st month and at the end of the 3rd month) include:
* Calculation of body mass index (BMI)
* Femoral cartilage thickness and quadriceps muscle thickness (USG)
* STAR index calculation
* Handgrip strength using Jamar dynamometer
* Five-times chair stand test
* Timed Up and Go test
* Six-minute walk test
* Visual Analog Scale (VAS) for pain
* WOMAC
* SF-36 Quality of Life Questionnaire
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Detailed Description
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In addition to the conventional treatment program, patients in the first group will also receive low-level laser therapy (LLLT). If the laser group is found to be superior at the end of the study, the patients who only received the exercise program will be recalled and administered LLLT. Patients who meet the inclusion criteria will be enrolled in the study.
Sample size calculations were based on data from a previous study by Alghadir et al. Using a mean of 3.25 and a standard deviation of 2.61 for the WOMAC pain subscale, the number of participants was calculated with 95% power and a 5% significance level. As a result, it was determined that at least 29 patients would be included in each group. Written informed consent will be obtained from each patient before enrollment. Randomization will be performed according to the order of patient admissions. Patients will be evaluated before treatment, and at the 1st and 3rd months post-treatment.
The dosage of laser application was selected based on the recommendations of the World Association for Photobiomodulation Therapy (WALT). Patients will be treated 5 sessions per week for 2 weeks. A total of 6 points will be treated, each for 60 seconds. The treatment will be applied using the BTL SMART 4000 laser device at a wavelength of 835 nm and a dose of 10 J/point.
The conventional home based exercise program includes: hip and knee range of motion (ROM) exercises; stretching exercises for the hamstring, calf, and quadriceps muscles; isometric, concentric, and eccentric strengthening exercises for the quadriceps, hamstrings, and hip adductors/abductors; relaxation exercises; and walking as aerobic exercises. The program will begin with ROM, stretching, relaxation, aerobic, and isometric strengthening exercises. After one week, concentric and eccentric strengthening exercises will be added using elastic bands. The home based exercise program will be performed 3 days a week, each exercise in 3 sets of 10 repetitions and 2 minutes of rest between sets. Aerobic walking at a moderate pace (as determined by the talk test: the patient can talk but not sing during exercise) for 30 minutes will be recommended. Each patient will be shown and taught the exercises to be performed at home, and will also be provided with illustrated instructions. The home based exercise program will continue for 12 weeks. Patients will be contacted by phone weekly during the first month, and then every two weeks thereafter, to assess their adherence to and continuation of the home based exercise program.
Before starting treatment, demographic information will be collected, medical history will be taken, and a physical examination will be performed. Pre-treatment evaluations include:
* Measurement of height, weight, and calculation of body mass index (BMI)
* Femoral cartilage thickness and quadriceps muscle thickness measurement via ultrasound
* Determination of the Sonographic Thigh Adjustment Ratio (STAR)
* Application of the SARC-F screening test; those scoring over 4 will undergo whole-body muscle mass measurement
* Handgrip strength (HGS) measurement using a Jamar hand dynamometer
* Five-times chair stand test (CST)
* Timed Up and Go (TUG) test
* Six-minute walk test
* Visual Analog Scale (VAS) for pain
* Western Ontario and McMaster Universities Arthritis Index (WOMAC)
* Short Form-36 (SF-36) quality of life questionnaire
Post-treatment evaluations (At the end of the 1st month and at the end of the 3rd month) include:
* Calculation of body mass index (BMI)
* Femoral cartilage thickness and quadriceps muscle thickness (USG)
* STAR index calculation
* Handgrip strength using Jamar dynamometer
* Five-times chair stand test
* Timed Up and Go test
* Six-minute walk test
* Visual Analog Scale (VAS) for pain
* WOMAC
* SF-36 Quality of Life Questionnaire
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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exercise group
The patients in this group will receive a conventional home-based exercise program.
home based exercise
The conventional home based exercise program includes: hip and knee range of motion (ROM) exercises; stretching exercises for the hamstring, calf, and quadriceps muscles; isometric, concentric, and eccentric strengthening exercises for the quadriceps, hamstrings, and hip adductors/abductors; relaxation exercises; and walking as aerobic exercises. The program will begin with ROM, stretching, relaxation, aerobic, and isometric strengthening exercises. After one week, concentric and eccentric strengthening exercises will be added using elastic bands. The home exercise program will be performed 3 days a week, each exercise in 3 sets of 10 repetitions and 2 minutes of rest between sets. Aerobic walking at a moderate pace (as determined by the talk test: the patient can talk but not sing during exercise) for 30 minutes will be recommended. Program will continue for 12 weeks.
exercise and LLLT group
This group of patients will receive LLLT treatment in addition to conventional home-based exercise program.
home based exercise
The conventional home based exercise program includes: hip and knee range of motion (ROM) exercises; stretching exercises for the hamstring, calf, and quadriceps muscles; isometric, concentric, and eccentric strengthening exercises for the quadriceps, hamstrings, and hip adductors/abductors; relaxation exercises; and walking as aerobic exercises. The program will begin with ROM, stretching, relaxation, aerobic, and isometric strengthening exercises. After one week, concentric and eccentric strengthening exercises will be added using elastic bands. The home exercise program will be performed 3 days a week, each exercise in 3 sets of 10 repetitions and 2 minutes of rest between sets. Aerobic walking at a moderate pace (as determined by the talk test: the patient can talk but not sing during exercise) for 30 minutes will be recommended. Program will continue for 12 weeks.
Low Level Laser Therapy
Patients will receive LLLT treatment, they will be treated in a supine position with the knee flexed to 30 degrees, 5 sessions per week for 2 weeks. A total of 6 points will be treated each for 60 seconds. The treatment will be applied using the BTL SMART 4000 laser device at a wavelength of 835 nm and a dose of 10 J/point.
Interventions
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home based exercise
The conventional home based exercise program includes: hip and knee range of motion (ROM) exercises; stretching exercises for the hamstring, calf, and quadriceps muscles; isometric, concentric, and eccentric strengthening exercises for the quadriceps, hamstrings, and hip adductors/abductors; relaxation exercises; and walking as aerobic exercises. The program will begin with ROM, stretching, relaxation, aerobic, and isometric strengthening exercises. After one week, concentric and eccentric strengthening exercises will be added using elastic bands. The home exercise program will be performed 3 days a week, each exercise in 3 sets of 10 repetitions and 2 minutes of rest between sets. Aerobic walking at a moderate pace (as determined by the talk test: the patient can talk but not sing during exercise) for 30 minutes will be recommended. Program will continue for 12 weeks.
Low Level Laser Therapy
Patients will receive LLLT treatment, they will be treated in a supine position with the knee flexed to 30 degrees, 5 sessions per week for 2 weeks. A total of 6 points will be treated each for 60 seconds. The treatment will be applied using the BTL SMART 4000 laser device at a wavelength of 835 nm and a dose of 10 J/point.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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IREM ADIGUZEL
Dr
Locations
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Ankara Etlik City Hospital
Ankara, YENIMAHALLE, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Ganjeh S, Rezaeian ZS, Mostamand J. Low Level Laser Therapy in Knee Osteoarthritis: A Narrative Review. Adv Ther. 2020 Aug;37(8):3433-3449. doi: 10.1007/s12325-020-01415-w. Epub 2020 Jul 3.
Chow R, Liebert A, Tilley S, Bennett G, Gabel CP, Laakso L. Guidelines versus evidence: what we can learn from the Australian guideline for low-level laser therapy in knee osteoarthritis? A narrative review. Lasers Med Sci. 2021 Mar;36(2):249-258. doi: 10.1007/s10103-020-03112-0. Epub 2020 Aug 8.
Stausholm MB, Naterstad IF, Joensen J, Lopes-Martins RAB, Saebo H, Lund H, Fersum KV, Bjordal JM. Efficacy of low-level laser therapy on pain and disability in knee osteoarthritis: systematic review and meta-analysis of randomised placebo-controlled trials. BMJ Open. 2019 Oct 28;9(10):e031142. doi: 10.1136/bmjopen-2019-031142.
Bennell KL, Hinman RS. A review of the clinical evidence for exercise in osteoarthritis of the hip and knee. J Sci Med Sport. 2011 Jan;14(1):4-9. doi: 10.1016/j.jsams.2010.08.002. Epub 2010 Sep 17.
Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
Kholvadia A, Constantinou D, Gradidge PJ. Exploring the efficacy of low-level laser therapy and exercise for knee osteoarthritis. S Afr J Sports Med. 2019 Jan 1;31(1):v31i1a6058. doi: 10.17159/2078-516X/2019/v31i1a6058. eCollection 2019.
Related Links
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World Association of Laser Therapy
Other Identifiers
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AEŞH-EK-2025-058
Identifier Type: -
Identifier Source: org_study_id
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