The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis

Study Overview
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Brief Summary
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LLLT is in use to treat different musculoskeletal condition. Osteoarthritis is one of the conditions needing LLLT for therapeutic effects. LLLT has been used in different previous studies using different points on joint and also on acupuncture points. This study is going to compare the effectiveness of LLLT on both points. Omega xp device is going to be used in this study.

Detailed Description
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LLLT is a non-invasive modality to treat variety of musculoskeletal conditions. Photobiomodulation has been studies for last two decades in different perspectives and on different musculoskeletal condition. Studies suggest profound results due to effect of LLLT at the cellular level. Osteoarthritis is one of the most common debilitating musculoskeletal condition affecting people worldwide. Statistics indicate an increase in this debilitating condition in future. Knee OA is more common amongst other OA of the body. LLLT has been used in previous studies to see the impact on pain and functional performance in knee OA. LLLT has been used on different points on knee joint and also applied on acupuncture points of the knee joints. Different outcomes were used to assess LLLT effectiveness including pain, ROM and even different biomarkers. This study is going to use LLLT on different particular joint points of knee and also acupuncture points of the knee joint and compare the outcomes. This study will present evidence for the clinicians to use LLLT on either the particular joint points or acupuncture points for better clinical outcomes.

Official Title
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The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain in the knee joint ( minimum 30/100 on VAS ) Kellgren-Lawrence Grade III knee OA ACR criteria for knee OA with radiological findings including ; age 35 and above joint crepitus less than 30 minutes of morning stiffness Exclusion Criteria: Knee OA grade other than III. Any contraindication of LLLT including; pregnancy carcinoma involving knee area Steroids and NSAIDS use

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study to compare the effectiveness of low level laser therapy on two groups of points of irradiation in knee OA grade III. One group of points involves 6-7 particular points on tibiofemoral and patellofemoral joints. Other group involves the 6-7 particular acupuncture points which have been previously used in a study. Outcomes will indicate that which group irradiation will produce better therapeutic results.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Particular joint point group<br>This group will receive laser irradiation on 6-7 particular points including 4-5 on tibiofemoral and 2 on patellofemoral joint. | Device: Low level laser therapy<br>* Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.<br>* Other names: Cold laser therapy;|
| Experimental: Acupuncture points group<br>This group will receive laser irradiation on 6-7 particular acupuncture points which have been previously used in another study and or identified in literature. | Device: Low level laser therapy<br>* Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.<br>* Other names: Cold laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) | Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance. | Baseline | 
| Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) | Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance. | 2nd week | 
| Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) | Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance. | 3rd week | 
| Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) | Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance. | 4th week | 
| Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) | Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance. | 16th week | 
| Timed Up and Go test ( TUG ) | Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance. | Baseline | 
| Timed Up and Go test ( TUG ) | Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance. | 2nd week | 
| Timed Up and Go test ( TUG ) | Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance. | 3rd week | 
| Timed Up and Go test ( TUG ) | Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means better performance and longer the time means poor performance. | 4th week | 
| Timed Up and Go test ( TUG ) | Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance. | 16th week | 
| Visual Analog Scale ( VAS ) | Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain. | Baseline | 
| Visual Analog Scale ( VAS ) | Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain. | 2nd week | 
| Visual Analog Scale ( VAS ) | Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain. | 3rd week | 
| Visual Analog Scale ( VAS ) | Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain. | 4th week | 
| Visual Analog Scale ( VAS ) | Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain. | 16th week |