Low-Level Laser Therapy in Knee Osteoarthritis: Effects on Clinical Outcomes, Femoral Cartilage Thickness and Regional Sarcopenia

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

Overview

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

Interventions

• Other 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 stren
• Device 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.

Primary outcome measures

• 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.]

Secondary outcome measures (9)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ankara Etlik City Hospital — Ankara

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( PMID 30312372
• 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. PMID 32621270
• 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. PMID 32770424
• 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. PMID 31662383
• 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. PMID 20851051
• 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. PMID 33666347
• 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. PMID 23912778
• 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. PMID 32941253

Identifiers

NCT: NCT07078877 · AEŞH-EK-2025-058

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗