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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:
Post-treatment evaluations (At the end of the 1st month and at the end of the 3rd month) include:
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:
Post-treatment evaluations (At the end of the 1st month and at the end of the 3rd month) include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise group | Active Comparator | The patients in this group will receive a conventional home-based exercise program. |
|
| exercise and LLLT group | Experimental | This group of patients will receive LLLT treatment in addition to conventional home-based exercise program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home based exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Ultrasound measurements will be performed on all patients during the pre-treatment assessment, as well as at the 1st and 3rd months after treatment. |
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Inclusion Criteria:
Individuals with knee osteoarthritis according to ACR criteria, Those at grade 2-3 according to the Kellgren-Lawrence scale, Individuals aged over 50 years
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IREM ADIGUZEL, MEDİCAL DOCTOR | Contact | +90 505 443 14 45 | altinsoyyirem@gmail.com | |
| OZGUR Z KARAAHMET, MEDİCAL DOCTOR | Contact | +90 505 815 15 85 | drozguroz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | YENIMAHALLE | 06170 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30312372 | Background | 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. | |
| 32621270 |
| Label | URL |
|---|---|
| World Association of Laser Therapy | View source |
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|
| Low Level Laser Therapy | Device | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | The scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment. |
| Background |
| 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. |
| 32770424 | Background | 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. |
| 31662383 | Background | 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. |
| 20851051 | Background | 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. |
| 33666347 | Background | 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. |
| 23912778 | Background | 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. |
| 32941253 | Background | 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. |
| 36817986 | Background | 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. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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