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CTRI Number  CTRI/2024/10/075926 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Low level laser with nerve, muscle training program and cardio exercise program in participants with knee arthritis. 
Scientific Title of Study   Effects of low level laser therapy with Neuromuscular training program and Aerobic exercise program in participants with knee osteoarthritis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thaheera D 
Designation  PG student 
Affiliation  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences. 
Address  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences, Thandalam, Chennai.

Chennai
TAMIL NADU
602105
India 
Phone  7448488400  
Fax    
Email  thaheeradeen72001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Thaheera D 
Designation  PG student 
Affiliation  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences. 
Address  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences, Thandalam, Chennai.

Chennai
TAMIL NADU
602105
India 
Phone  7448488400  
Fax    
Email  thaheeradeen72001@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thaheera D 
Designation  PG student 
Affiliation  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences. 
Address  Saveetha college of physiotherapy, Saveetha institute of medical and technical sciences, Thandalam, Chennai.

Chennai
TAMIL NADU
602105
India 
Phone  7448488400  
Fax    
Email  thaheeradeen72001@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college and hospital, Saveetha Nagar, Thandalam, Chennai-602105. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
KKotteeswaran  Saveetha medical college and hospital.  OPD- Department of physiotherapy, No: 162, poonamalle high road, Chennai, saveetha nagar.
Chennai
TAMIL NADU 
9894286700

k.kotteeswaran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutuional scientific review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low level laser therapy with Neuromuscular training program.  Low level laser therapy: Five points on the medial side of the knees synovial region, four points on the lateral side, and a wavelength of 904 nm, a frequency of 700 Hz, an average power of 60 nm, and a peak power of 20 w were covered by low level laser therapy over the joint line. For eight weeks, LLLT was administered four days a week. [21] Core stability Pelvic lift:The participants were asked to lie down in supine position with the feet on a swiss ball (diameter 55-75 cm) with the knees extended to a maximum of 5°flexion. Sit ups:The participants were asked to Lie down in supine with knees flexed to 90 degrees with both legs on ball. Muscle strength Hip abductors and adductors: The participants were asked to stand in unaffected leg, rubber band on other leg. By pulling the rubber band out. Knee flexors and extensors The participants were asked to sit down, with the theraband around the one foot Pull the theraband forward and then backwards. The tension in the theraband should be maintained and also in resting position. Squat: The participants were instructed to Stand with the feet hip-width apart in front of a chair or stool, the knee shall be flexed to an extent so the buttocks just touch the chair without sitting down.ensure a soft, controlled landing. Side lying jump jacks: In side lying with eight on the forearm and hip good alignment in the shoulder, spine, pelvis, and knees, in side lying with weight on the forearm and hip. Lunges: Stand with hip apart. Take a long step forward without lifting the toes of rear foot. The landing must be controlled and done in smooth motion. The body is lowered down so the knee almost touches the floor and the heel of the front foot remains on the floor. Functional exercises Chair stands: Standing with the feet width hip apart in front of a chair or stool, the knee shall be flexed to an extent so the buttock just touch the stair without sitting down. Stair climbing (step up, side step up, step down): Stand with front to step bench. Height of step is (13, 18 or 23cm) is used for progression. (Cool down) Stretches- Hamstring, quadriceps, calf muscles, triceps surae Walking-Forward and backward walking in front of mirror  
Comparator Agent  Low level therapy with Aerobic exercises program.  Five points on the medial side of the knees synovial region, four points on the lateral side, and a wavelength of 904 nm, a frequency of 700 Hz, an average power of 60 nm, and a peak power of 20 w were covered by low level laser therapy over the joint line. For eight weeks, LLLT was administered four days a week. Aerobic exercise program: Stationary bicycle-15 minutes Trunk rotation Stepper machine Slow Walking – starting from 10 mins to 30 miutes Quadriceps settting Staright leg raises Full arc extension Cycling in air Wall slides  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed with osteoarthritis knee according to the ACR criteria
Radiologically stage II, III with unilateral osteoarthritis knee according to the KL scale.
BMI less than 30 
 
ExclusionCriteria 
Details  Corticosteroids before 6 months
Recent or previous fracture to the knee joint.
Visual, hearing and cognitive impairment.
Previous surgery to knee.
Have self reported inflammatory arthritis. Cardiovascular diseases and with neurological disorders 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pressure algometer, Time up and Go test, 30 sec STS, ROM.  Pressure algometer, Time up and Go test, 30 sec STS, ROM. 
 
Secondary Outcome  
Outcome  TimePoints 
WOMAC  8th week 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   03/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Effects of low level laser therapy with neuromuscular training program and aerobic exercises program in participants with knee osteoarthritis.

 

BACKGROUND:

 

Osteoarthritis (OA) is a widespread chronic degenerative disease that mostly affecting the weight-bearing joints, with the knee joint having highest prevalence of OA. [1] Osteoarthritis (OA), the most prevalent kind of cartilage degeneration mostly affects the hips, knees, hands, and feet. It also accounts for the disease’s expenses to the health system and diminished quality of life. [2] Not only OA patients engage in less physical activity, but research indicates that 42% of them also have depression and mental health issues. Approximately 10% of OA workers missed work, and almost 7% of them were present but had more severe depressed symptoms. Thus, OA is recognized to contribute significantly to the global illness burden in addition to causing physical disability, mental health issues, and social dysfunction. [3]

 

Older age, gender, obesity, injury to the knee joint, occupational hazards (e.g., knee bending, and squatting during work), and varus or valgus alignment have all been linked to an increased chance of knee osteoarthritis. [4] Its visibility is made possible by the radiograph, which may be assessed using the KL grading system. This grading system gives medical professionals the ability to create treatment protocols, which aids in clinical decision-making. [5, 6] By 2020, OA is predicted to account for 4th most prevalent cause globally, with a 40% rise in prevalence. The prevalence of knee OA worldwide was 3.8% in 2010.

NEED FOR THE STUDY:

The management of knee osteoarthritis (OA) remains a significant clinical challenge due to its high prevalence, limited treatment options, and inadequate symptom relief. Low-Level Laser Therapy (LLLT), Neuromuscular Training Program (NMTP), and Aerobic Exercise Program (AEP) have shown promise in alleviating knee OA symptoms. However, the combined effectiveness of these therapies, optimal LLLT parameters, and comparative effectiveness versus individual therapies remain unclear. This study aims to address these knowledge gaps, providing valuable insights into the development of personalized, evidence-based treatment plans for patients with knee OA. By investigating the synergistic effects of LLLT, NMTP, and AEP, this research will enhance treatment options, and ultimately improve the quality of life for individuals afflicted with knee OA.

AIM AND PURPOSE OF THE STUDY:

To compare the effects of low level laser therapy with neuromuscular training program and aerobic exercises training program in participants with knee osteoarthritis.

OBJECTIVES:

To evaluate out the effects of low level laser therapy with neuromuscular training on pain using pressure algometer.

To evaluate the effects of low level laser therapy with aerobic exercises program on pain using pressure algometer.

To evaluate the effects of low level laser therapy with neuromuscular training on function using Timed up and go test.

To evaluate the effects of low level laser therapy with aerobic exercises program on function using timed up and go test.

To evaluate the effects of low level laser therapy with neuromuscular training on muscle strength using 30seconds sit to stand test.

To evaluate the effects of low level laser therapy with aerobic exercises program on muscle strength using 30seconds sit to stand test.

INCLUSON AND EXCLUSION CRITERIA:

The study included  participants aged 50 to 60 years, both male (n=45) and female (n=61) who were diagnosed with osteoarthritis knee according to the ACR criteria, radiologically stage  II, III with unilateral osteoarthritis knee according to the KL scale and BMI less than 30. The participants who had taken corticosteroids before 6 months, recent or previous fracture to the knee joint, visual, hearing and cognitive impairment, previous surgery to knee, have self reported inflammatory arthritis, cardiovascular diseases and with neurological disorders were excluded from the study due to making them exercise and testing impossible.

Low level laser therapy:

Five points on the medial side of the knee’s synovial region, four points on the lateral side, and a wavelength of 904 nm, a frequency of 700 Hz, an average power of 60 nm, and a peak power of 20 w were covered by low level laser therapy over the joint line. For eight weeks, LLLT was administered four days a week. [21]

 

Core stability

Pelvic lift:The participants were asked to lie down in supine position with the feet on a swiss ball (diameter 55-75 cm) with the knees extended to a maximum of 5°flexion.

Sit ups:The participants were asked to Lie down in supine with  knees flexed to 90 degrees with both legs on ball.

Muscle strength

Hip abductors and adductors: The participants were asked to stand in unaffected leg, rubber band on other leg. By pulling the rubber band out.

Knee flexors and extensors The participants were asked to sit down, with the theraband around the one foot Pull the theraband  forward and then backwards.  The  tension in the theraband should be maintained and also in resting position.

Squat: The participants were instructed to Stand with the feet hip-width apart in front of a chair or stool, the knee shall be flexed to an extent so the buttocks just touch the chair without sitting down.ensure a soft, controlled landing.

Side lying jump jacks: In side lying with eight on the forearm and hip  good alignment in the shoulder, spine, pelvis, and knees, in side lying with weight on the forearm and hip.

Lunges: Stand with hip apart. Take a long step forward without lifting the toes of rear foot. The landing must be controlled and done in smooth motion. The body is lowered down so the knee almost touches the floor and the heel of the front foot remains on the floor.

Functional exercises

Chair stands: Standing with the feet width hip apart in front of a chair or stool, the knee shall be flexed to an extent so the buttock  just touch the stair without sitting down.

Stair climbing (step up, side step up, step down): Stand with front to step bench. Height of step is (13, 18 or 23cm) is used for progression.

(Cool down)

Stretches- Hamstring, quadriceps, calf muscles, triceps surae

Walking-Forward and backward walking in front of mirror

AEROBIC EXERCISE PROGRAM:

Stationary bicycle-15 minutes

Trunk rotation

Stepper machine

Slow Walking – starting from 10 mins to 30 miutes

Quadriceps settting

Staright leg raises

Full arc extension

Cycling in air

Wall slides

 Outcome measure:

Mechanical pain was analyzed using pressure algometer. In this study, a female physical therapist (blinded to the study). All PPT measurements were performed by the same examiner. In addition, the pressure algometer is measured vertical position than horizontally, which is preferable while applying the pressure. The PPT was then evaluated in all patients at one place by a single rater: the medial side of the patient’s affected knee (about 1 to 2 cm mediolateral to the medial femoral tubercle). These bodily locations were selected because, in people with knee OA, they are painful respectively. The participants were advised to make a verbal signal as soon as the sensation of pressure became painful, at which point the rater withdrew the algometer and recorded the score. Three measurements of the PPT were taken at each location on each side of the body, beginning at the ankle and working up to the knee.  A study conducted by [Ebru Kaya Mutlu, (2015)] concluded that, pressure algometer is a responsive and reliable method of measuring PPT that may be applied in clinical practice to patients with knee OA.  (ICC=0.96-0.97). [27]

Time up go test:

Physical function is measured by TUG test. The amount of time needed to get out of the chair, move three meters on the ground, turn around, come back, and sit down again is time is noted with stopwatch. The test was announced to the patients earlier. Throughout the test, they wore comfortable shoes. It takes seconds to calculate the average of three tests. The same researcher conducted each measurement. The TUG test for all the participants showed excellent intra- and inter-rater reliability (ICC - 0 .97 and 0.96).

30 seconds STS:

30 Seconds sit to stand test was used to measure muscle strength. The participants were asked to be seated on the armless chair. The same chair was used for all the test episodes. The chair was placed against the wall to prevent it from moving during the test. The arms of the participants were crossed at the wrist and held against the chest. The count should be noted how many times the participants sit to stand within 30 seconds of time limit. The participants were instructed to fully sit down on the chair between each stand.

 

 

 
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