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临床试验/NCT07078877
NCT07078877招募中不适用

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

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
62
试验地点
1
主要终点
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Individuals with knee osteoarthritis according to ACR criteria, Those at grade 2-3 according to the Kellgren-Lawrence scale, Individuals aged over 50 years

排除标准

  • •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

研究组 & 干预措施

exercise group

Active Comparator

The patients in this group will receive a conventional home-based exercise program.

干预措施: home based exercise (Other)

exercise and LLLT group

Experimental

This group of patients will receive LLLT treatment in addition to conventional home-based exercise program.

干预措施: home based exercise (Other)

exercise and LLLT group

Experimental

This group of patients will receive LLLT treatment in addition to conventional home-based exercise program.

干预措施: Low Level Laser Therapy (Device)

结局指标

主要结局

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

时间窗: 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.

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

时间窗: 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.

次要结局

  • Femoral cartilage 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.)
  • Quadriceps 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(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 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.)
  • Femoral cartilage 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.)
  • Quadriceps 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(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 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 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 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(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(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 scale will be administered to all patients before starting treatment, at the 1st and 3rd months after the initiation of treatment.)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

IREM ADIGUZEL

Dr

Ankara Etlik City Hospital

研究点 (1)

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