High Intensity Laser and Exercises in Knee OA
Primary Purpose
Chronic Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Knee Osteoarthritis focused on measuring knee, osteoarthritis, HILT, exercise, pain, function
Eligibility Criteria
Inclusion Criteria:
- All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
- Aged between 50- 70 years
- Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
- Body mass index (BMI) ≤30 kg/m2.
- Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
- All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university
Exclusion Criteria:
Patients will be excluded if they have the following conditions:
- History of joint replacement.
- Symptoms or signs suggestive of another cause of knee pain.
- Rheumatoid arthritis.
- Steroid injection or knee surgery (previous six months).
- acute inflammation around knee joint.
- Underlying disease such as malignancy.
- Infection or systemic disease of musculoskeletal system
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
1500 J + exercises
3000 J + exercises
exercises + sham LASER
Arm Description
consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises.
consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises.
consist of 17 patients, they will apply exercises plus sham LASER.
Outcomes
Primary Outcome Measures
visual analogue scale
pain intensity
The functional disability assessment
The Western Ontario and McMaster Universities Osteoarthritis Index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04751253
Brief Title
High Intensity Laser and Exercises in Knee OA
Official Title
The Combined Effect Of Different Doses Of High-Intensity Laser And Traditional Exercise On Pain And Function In Patients With Chronic Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
Detailed Description
Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world.
Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence.
As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Knee Osteoarthritis
Keywords
knee, osteoarthritis, HILT, exercise, pain, function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1500 J + exercises
Arm Type
Active Comparator
Arm Description
consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises.
Arm Title
3000 J + exercises
Arm Type
Active Comparator
Arm Description
consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises.
Arm Title
exercises + sham LASER
Arm Type
Sham Comparator
Arm Description
consist of 17 patients, they will apply exercises plus sham LASER.
Intervention Type
Device
Intervention Name(s)
High Intensity Laser Therapy
Intervention Description
different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
Primary Outcome Measure Information:
Title
visual analogue scale
Description
pain intensity
Time Frame
8 weeks
Title
The functional disability assessment
Description
The Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
Aged between 50- 70 years
Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
Body mass index (BMI) ≤30 kg/m2.
Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university
Exclusion Criteria:
Patients will be excluded if they have the following conditions:
History of joint replacement.
Symptoms or signs suggestive of another cause of knee pain.
Rheumatoid arthritis.
Steroid injection or knee surgery (previous six months).
acute inflammation around knee joint.
Underlying disease such as malignancy.
Infection or systemic disease of musculoskeletal system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona M ibrahim, professor
Phone
+201002992613
Email
mona.ibrahiem@cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
High Intensity Laser and Exercises in Knee OA
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