Back to resultsEvaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Laser Therapy, Muscle Strength
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high-intensity laser therapy
sham high-intensity laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
Exclusion Criteria:
- History of surgery or traumatic injury
- Inflammatory arthritis
- History of cancer, bleeding diathesis and psychiatric disease
- Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
- Hip and ankle problems
- Participating in another physical therapy program in the last 3 months
- History of intra-articular injections in the last 6 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
High-intensity laser therapy
Sham high-intensity laser therapy
Arm Description
A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The hotpack, which is used as a superficial heater, is applied to the knee area for 30 minutes, wrapped in two layers of towels. As analgesic current, conventional TENS is applied to the knee area for 30 minutes with 4 electrodes at 80 Hz frequency, 200 ms current duration. Flow intensity is adjusted according to the patient's tolerance, and the current intensity is increased as the patient's sense of current decreased in the following periods. HILT is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.
Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Secondary Outcome Measures
Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3
The range of motion of the patients, consisting of knee flexion and extension, is actively evaluated with a goniometer. In the measurement of the flexion angle, the patient is lying in the prone position and the extension angle is measured as the limitation of extension when the knee joint is at 0 degrees
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
Femoral cartilage thickness is measured by the same physician by placing the probe axially in the suprapatellar region by ultrasonography while the patient is lying on his back and the knees are in maximum flexion. The distance between the thin hyperechoic line at the synovial cartilage interface and the sharp hyperechoic line at the cartilage-bone interface is defined as cartilage thickness
SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3
The SF-36 scale measures 8 dimensions of health and consists of 36 items; physical function (10 items), social function (2 items), role related to physical functions limitations (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/fatigue (4 items), pain (2 items), and general perception of health (5 items). It is evaluated between 0 and 100 points; 0 represents poor health, 100 represents good health. There are two summary components, the physical component and the mental component
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3
It is widely used in studies with knee OA patients. The scale, each question of which is evaluated with a 5-point Likert scale, consists of 24 questions. It is filled by patients. There are pain, physical function and stiffness subscales. Pain subscale is evaluated with five items and is scored between 0-20. The hardness subscale has two items and is scored between 0-8. Function subscale consists of 17 items and is scored between 0-68. A high score indicates poor function, pain or stiffness.
Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3
Knee isokinetic muscle strength is measured with the Biodex System-3 isokinetic device . At 60° and 180° angular velocities, the range of motion was 90° flexion 0° extension, after three repetitions at each angular velocity; Measurements are made in a single set-five repetitions with 10 seconds of rest between repetitions
Full Information
NCT ID
NCT05510648
First Posted
August 18, 2022
Last Updated
September 27, 2022
Sponsor
Necmettin Erbakan University
1. Study Identification
Unique Protocol Identification Number
NCT05510648
Brief Title
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
Official Title
The Effect of High-intensity Laser Therapy in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2022 (Anticipated)
Primary Completion Date
September 25, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.
Detailed Description
Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Laser Therapy, Muscle Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-intensity laser therapy
Arm Type
Active Comparator
Arm Description
A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The hotpack, which is used as a superficial heater, is applied to the knee area for 30 minutes, wrapped in two layers of towels. As analgesic current, conventional TENS is applied to the knee area for 30 minutes with 4 electrodes at 80 Hz frequency, 200 ms current duration. Flow intensity is adjusted according to the patient's tolerance, and the current intensity is increased as the patient's sense of current decreased in the following periods. HILT is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.
Arm Title
Sham high-intensity laser therapy
Arm Type
Sham Comparator
Arm Description
Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.
Intervention Type
Other
Intervention Name(s)
high-intensity laser therapy
Intervention Description
A total of 15 sessions of hotpack, TENS and exercise program will be applied to the patients for three weeks, 5 days a week, 1 session a day. The patients in the HILT group will be treated with a BTL 6000 brand device (Figure 5) for 3 sessions of high-intensity laser with a power of 10.0 w in the first week, energy density of 12 j/cm², every 25 cm² for 2 minutes in analgesic mode, and 5 sessions in the following 2 weeks. While 6 sessions of .0 w power, energy density of 120 j/cm², each 25 cm² for 10 minutes, will be applied in biostimulant mode for 6 sessions for three weeks, is applied in analgesic mode for 3 sessions every other day in the first week, and 6 sessions every other day in the biostimulant mode for the next two weeks, for a total of 9 sessions for three weeks.
Intervention Type
Other
Intervention Name(s)
sham high-intensity laser therapy
Intervention Description
Hotpack, TENS and exercise program applications will be applied to the patients in the same way as in the HILT group, 5 days a week, 1 session a day, a total of 15 sessions for three weeks. HILT is administered as a placebo for three weeks, 3 sessions a week, every other day, for a total of 9 sessions.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
Description
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
Time Frame
Baseline and month 3
Secondary Outcome Measure Information:
Title
Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3
Description
The range of motion of the patients, consisting of knee flexion and extension, is actively evaluated with a goniometer. In the measurement of the flexion angle, the patient is lying in the prone position and the extension angle is measured as the limitation of extension when the knee joint is at 0 degrees
Time Frame
Baseline and month 3
Title
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
Description
Femoral cartilage thickness is measured by the same physician by placing the probe axially in the suprapatellar region by ultrasonography while the patient is lying on his back and the knees are in maximum flexion. The distance between the thin hyperechoic line at the synovial cartilage interface and the sharp hyperechoic line at the cartilage-bone interface is defined as cartilage thickness
Time Frame
Baseline and month 3
Title
SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3
Description
The SF-36 scale measures 8 dimensions of health and consists of 36 items; physical function (10 items), social function (2 items), role related to physical functions limitations (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/fatigue (4 items), pain (2 items), and general perception of health (5 items). It is evaluated between 0 and 100 points; 0 represents poor health, 100 represents good health. There are two summary components, the physical component and the mental component
Time Frame
Baseline and month 3
Title
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3
Description
It is widely used in studies with knee OA patients. The scale, each question of which is evaluated with a 5-point Likert scale, consists of 24 questions. It is filled by patients. There are pain, physical function and stiffness subscales. Pain subscale is evaluated with five items and is scored between 0-20. The hardness subscale has two items and is scored between 0-8. Function subscale consists of 17 items and is scored between 0-68. A high score indicates poor function, pain or stiffness.
Time Frame
Baseline and month 3
Title
Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3
Description
Knee isokinetic muscle strength is measured with the Biodex System-3 isokinetic device . At 60° and 180° angular velocities, the range of motion was 90° flexion 0° extension, after three repetitions at each angular velocity; Measurements are made in a single set-five repetitions with 10 seconds of rest between repetitions
Time Frame
Baseline and month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
Exclusion Criteria:
History of surgery or traumatic injury
Inflammatory arthritis
History of cancer, bleeding diathesis and psychiatric disease
Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
Hip and ankle problems
Participating in another physical therapy program in the last 3 months
History of intra-articular injections in the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BANU ORDAHAN
Phone
5058741256
Email
banuordahan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BANU ORDAHAN
Organizational Affiliation
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
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