Knee OsteoarthritisNCT07078877
Low-Level Laser Therapy in Knee Osteoarthritis: Effects on Clinical Outcomes, Femoral Cartilage Thickness and Regional Sarcopenia
A study testing home based exercise and Low Level Laser Therapy in people with Knee Osteoarthritis and Low Level Laser Therapy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
It was designed as a single-center, prospective, randomized controlled study. The study consists of two groups. Both groups of patients will receive a conventional home based exercise program. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Low Level Laser Therapy, Regional Sarcopenia
- What is being tested?
- home based exercise and Low Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with knee osteoarthritis according to ACR criteria, Those at grade 2-3 according to the Kellgren-Lawrence scale, Individuals aged over 50 years
Who cannot join
- Individuals with a history of trauma or surgery to the knee joint, Those who have received intra-articular injection to the knee within the last 3 months, Those who have undergone physical therapy or exercise treatment in the past year, Individuals with a pacemaker, Patients with high cardiac risk, Those with active malignancy, Individuals with genetic bone or joint disease, Those with a BMI > 35 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, YENIMAHALLE, 06170
ETİK KURUL SEKRETERLİĞİ, 903127970000, etliksh.etikkurul@saglik.gov.tr
About this study
Official title: Investigation of Sarcopenia in Patients With Knee Osteoarthritis and the Effect of Low-Level Laser Therapy on Sonographically Measured Femoral Cartilage and Quadriceps Thickness, Clinical Outcomes, and Regional Sarcopenia
It was designed as a single-center, prospective, randomized controlled study. The study consists of two groups. Both groups of patients will receive a conventional home based exercise program.
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.
Read more
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
Read the detailed description
It was designed as a single-center, prospective, randomized controlled study. The study consists of two groups. Both groups of patients will receive a conventional treatment program. Within the scope of the conventional treatment program, an exercise program (including range of motion, stretching, relaxation, strengthening, and aerobic exercises) will be administered.
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
- Being tested
- home based exercise, Low Level Laser Therapy
- Keywords
- knee osteoarthritis, low level laser therapy, regional sarcopenia, Exercise Therapy, sarcopenia
- Medical subject headings
- Osteoarthritis, Knee, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home based exerciseOther
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Active comparator | The patients in this group will receive a conventional home-based exercise program. Receives: Other: home based exercise |
| exercise and LLLT group | Experimental | This group of patients will receive LLLT treatment in addition to conventional home-based exercise program. Receives: Other: home based exercise; Device: Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC consists of 24 questions divided into 3 subscales. Each question is scored on a scale from 0 to 4, with the scores corresponding to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed for each subscale.
Measured: The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.
Secondary outcomes (9)
Femoral cartilage thickness
The patient will be asked to bring their knee into full flexion while lying in the supine position. Medial, lateral, and intercondylar femoral cartilage thickness will be measured using ultrasound with a 5- to 12-MHz linear probe.
Measured: Ultrasound measurements will be performed on all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Quadriceps Muscle Thickness
The rectus femoris and vastus intermedius of the quadriceps femoris will be evaluated. Measurements will be performed as described in previous studies. While the patient lies in a relaxed supine position, a transverse image will be obtained with ultrasound using linear probe from the midpoint of the line between the anterior superior iliac spine (ASIS) and the superior border of the patella. The average of three measurements of the vastus intermedius and rectus femoris muscles will be recorded as the muscle thickness.
Measured: Ultrasound measurements will be performed on all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Determination Sonographic Thigh Adjustment Ratio (STAR) value
For the assessment of regional sarcopenia, the Sonographic Thigh Adjustment Ratio (STAR) value will be determined as described in previous studies. Anterior thigh muscle thickness will be measured using ultrasound, and the STAR value will be calculated by dividing the anterior thigh muscle thickness by the body mass index (BMI). In previous studies, STAR cutoff values for diagnosing sarcopenia were identified as 1.0 for women and 1.4 for men.
Measured: The STAR value will be measured to all patients before the start of the study, as well as at the 1st and 3rd months after the study begins.
Visual analog scale pain score
The patient will be shown the VAS pain scale and asked to select their pain level both at rest and during movement. The score will increase as the pain intensifies, and the results will be recorded.
Measured: The VAS pain score will be administered to all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Five times chair stand test (CST)
The patient is asked to cross their arms in front, stand up and sit down five times. The stopwatch is started as the patient begins to stand up and stopped after completing five repetitions. The duration is recorded in seconds.
Measured: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
Timed Up and Go (TUG)
The patient crosses their arms in front and stands up without support. The stopwatch is started as the patient begins to stand. The patient walks 3 meters, turns around, and returns to sit down. The stopwatch is stopped once the patient is seated again. The time is recorded in seconds.
Measured: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
Hand Grip Strength
Patients' hand grip strength will be measured using a Jamar hand dynamometer. The measurements will be taken While the patients are seated with their shoulders in adduction and neutral position, elbows flexed at 90 degrees, and forearms/wrists in a neutral position.
Measured: The measurment will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
6 minutes walk test
In the 6-minute walk test, the patient is instructed to walk as far as possible without running along a straight corridor of at least 30 meters. At the end of 6 minutes, the total distance walked is measured.
Measured: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
The Short Form 36 (SF-36)
The Short Form 36 (SF-36) is a health survey which includes 36 questions. It involves 8 different assessments.
Measured: The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start14 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, IREM ADIGUZEL, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078877
- Sponsor's protocol ID
- AEŞH-EK-2025-058
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30312372Ganjeh 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.
PubMed 32621270Chow 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.
PubMed 32770424Stausholm 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.
PubMed 31662383Bennell 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.
PubMed 20851051Raposo 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.
PubMed 33666347Alghadir 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.
PubMed 23912778Kara 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.
PubMed 32941253Kholvadia 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.
PubMed 36817986
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sarcopenia in Patients With Knee Osteoarthritis and the Effect of Low-Level Laser Therapy on Sonographically Measured Femoral Cartilage and Quadriceps Thickness, Clinical Outcomes, and Regional Sarcopenia
- ClinicalTrials.gov ID
- NCT07078877
- Acronym / sponsor ID
- AEŞH-EK-2025-058
- Keywords
- knee osteoarthritis, low level laser therapy, regional sarcopenia, Exercise Therapy, sarcopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It was designed as a single-center, prospective, randomized controlled study. The study consists of two groups. Both groups of patients will receive a conventional home based exercise program.
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
Detailed description
It was designed as a single-center, prospective, randomized controlled study. The study consists of two groups. Both groups of patients will receive a conventional treatment program. Within the scope of the conventional treatment program, an exercise program (including range of motion, stretching, relaxation, strengthening, and aerobic exercises) will be administered.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Active comparator | Other: home based exerciseThe patients in this group will receive a conventional home-based exercise program. |
| exercise and LLLT group | Experimental | Other: home based exercise, Device: Low Level Laser TherapyThis group of patients will receive LLLT treatment in addition to conventional home-based exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with knee osteoarthritis according to ACR criteria, Those at grade 2-3 according to the Kellgren-Lawrence scale, Individuals aged over 50 years
Key exclusion criteria (1 listed)
- Individuals with a history of trauma or surgery to the knee joint, Those who have received intra-articular injection to the knee within the last 3 months, Those who have undergone physical therapy or exercise treatment in the past year, Individuals with a pacemaker, Patients with high cardiac risk, Those with active malignancy, Individuals with genetic bone or joint disease, Those with a BMI > 35 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home based exerciseThe 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. | Other | exercise and LLLT group, exercise group |
| Low Level Laser TherapyPatients 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. | Device | exercise and LLLT group |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.
The WOMAC consists of 24 questions divided into 3 subscales. Each question is scored on a scale from 0 to 4, with the scores corresponding to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are summed for each subscale.
9 secondary outcomes
Femoral cartilage thickness
Time frame: Ultrasound measurements will be performed on all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Quadriceps Muscle Thickness
Time frame: Ultrasound measurements will be performed on all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Determination Sonographic Thigh Adjustment Ratio (STAR) value
Time frame: The STAR value will be measured to all patients before the start of the study, as well as at the 1st and 3rd months after the study begins.
Visual analog scale pain score
Time frame: The VAS pain score will be administered to all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment.
Five times chair stand test (CST)
Time frame: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
Timed Up and Go (TUG)
Time frame: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
Hand Grip Strength
Time frame: The measurment will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
6 minutes walk test
Time frame: The test will be administered to all patients before starting treatment, as well as at the 1st and 3rd months after the initiation of treatment.
The Short Form 36 (SF-36)
Time frame: The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 32621270Ganjeh 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.
- Background: PubMed 32770424Chow 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.
- Background: PubMed 31662383Stausholm 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.
- Background: PubMed 20851051Bennell 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.
- Background: PubMed 33666347Raposo 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.
- Background: PubMed 23912778Alghadir 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.
- Background: PubMed 32941253Kara 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.
- Background: PubMed 36817986Kholvadia 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.
- World Association of Laser TherapyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home based exercise and Low Level Laser Therapy in people with Knee Osteoarthritis and Low Level Laser Therapy, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IREM ADIGUZEL, MEDİCAL DOCTOR (+90 505 443 14 45, altinsoyyirem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078877, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.