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CTRI Number  CTRI/2024/07/071500 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between effectiveness of proprioceptive exercises and strengthening exercises with common use of ultrasound therapy in knee osteoarthritis patients 
Scientific Title of Study   Effectiveness of proprioceptive exercises versus strengthening exercises with common use of ultrasound therapy in patients with osteoarthritis of knee 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhurima Saha 
Designation  Master of Physiotherapy student 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  9051125878  
Fax    
Email  madhurima17.saha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyen Bhattacharyya 
Designation  Associate Professor 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  8348050005  
Fax    
Email  fitofine.in@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MS Anwar PT 
Designation  Principal 
Affiliation  Burdwan Institute of Medical and Life Sciences 
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman

Barddhaman
WEST BENGAL
713104
India 
Phone  9732445289  
Fax    
Email  anwarshahzada@yahoo.com  
 
Source of Monetary or Material Support  
Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman  
 
Primary Sponsor  
Name  Madhurima Saha 
Address  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman  
Type of Sponsor  Other [Self] 
 
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 
Dr Madhurima Saha  Burdwan Institute of Medical and Life Sciences  Exercise therapy lab, Department of Physiotherapy, Burdwan Institute of Medical and Life Sciences, University Campus, Golapbag, University Road, Barddhaman
Barddhaman
WEST BENGAL 
9051125878

madhurima17.saha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Burdwan Institute of Medical and Life Sciences Bardhaman India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PROPRIOCEPTIVE EXERCISES  Proprioception is the perception received from central nervous system and proprioceptive receptors. Knee proprioception is required for protection against any movement that can cause injury and also helps to maintain stability of joint and maintains normal co-ordination of joint during movement. 1. One leg balance in which patient will hold this position for 1 minute followed by 10-20 seconds of rest and after that two more repetitions will be carried out. Patient will perform 3 similar repetitions for another leg. 2. Blind advanced one leg balance in which patient will hold this position for 1 minute followed by 10-20 seconds of rest and after that two more repetitions will be carried out. Patient will perform 3 similar repetitions for another leg. 3. Toe walking in which patient will walk 20 meters on toes and will perform this for 1 more repetition. 4. Heel walking in which patient will walk 20 meters on heels and will perform this for 1 more repetition. 5. Cross leg body swing in which patient will perform this for 15 repetitions. After a few seconds of rest patient will perform similar 15 repetitions with another leg as the weight bearing limb. All this exercises will be performed 6 times aweek for 4 weeks. 
Intervention  STRENGTHENING EXERCISES  Strengthening exercises can be defined as systemic work of a single or group of muscles by lifting, lowering or controlling heavy loads for a short span of time with low number of repetitions.One of the risk factor for osteoarthritis of knee development is quadriceps muscle weakness. Quadriceps muscle helps in various functional activities like getting up from chair, independent walking, stair climbing and squatting. Studies have shown that quadriceps muscle strengthening exercises are beneficial for osteoarthritis of knee patients in reducing pain and improving function of knee joint. 1. Static quadriceps in knee extension in which patient will each contraction will be hold for 6 secs with 10 secs of rest between the repetitions. 2. Standing terminal knee extension in which each contraction will be hold for 3 seconds. Resistance will be increased according to patient’s tolerance. 3. Seated leg press in which patient will hold each contractions for 3 seconds with knee as straight as possible and then will slowly return to the starting position. Each of the exercises will be performed 10 repitations at a time for 6 times a week for 4 weeks. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  -Patient diagnosed of knee osteoarthritis with radiographic evidence of Grade II as per
Kellgren and Lawrence criteria
- Bilateral osteoarthritis of knee 
 
ExclusionCriteria 
Details  - Identified case of osteoporosis
- Knee meniscus or ligament injuries
- Metal implant in lower limb
- Steroid injections in past 2 months
- Cognitive disorders
- Vascular and sensory problems
- Hip or spinal problems referring pain to knee
- Patients with recent knee surgeries
- Rheumatoid arthritis
- Secondary osteoarthritis due to trauma
- Skin disease around the treatment area 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
WOMAC( Western Ontario and McMaster Universities Osteoarthritis index)  1st day of treatment and after 4 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Range of motion measurement  1st day of treatment and after 4 weeks of treatment  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   06/08/2024 
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="8"
Days="10" 
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  

INTRODUCTION

Osteoarthritis is the most common form of chronic arthritis affecting the synovial joints and is the common cause for disability worldwide. The terminology osteoarthritis comprises of two different terms where “osteo” means bone and “arthritis” means joint inflammation. Osteoarthritis is defined as a chronic progressive disease of synovial joints that is characterized by articular cartilage erosion, osteophytes formation at subchondral bone margins, inflammation of synovial membrane and resulting in pain, reduced range of motion, muscle weakness and eventually difficulty in performing daily activities. Osteoarthritis is also known as degenerative joint disease, wear and tear arthritis and age related arthritis. Knee is the joint most commonly affected by osteoarthritis and its prevalence is more in people above 60 years of age.  Knee osteoarthritis involves all three compartments of knee joint: medial tibiofemoral joint, lateral tibiofemoral joint and patellofemoral joint. Risk factors of knee osteoarthritis can be described as systemic risk factors, joint level risk factors, non-modifiable risk factors and modifiable risk factors. Systemic risk factors includes elderly age group (>60 years) and female population. Joint level risk factors include joint injury due to repitative trauma and abnormal loading on the joint. Apart from systemic and joint level risk factors modifiable risk factors also include any hereditary conditions and congenital abnormalities like genu valgum and genu varum. The most common modifiable risk factor include obesity (BMI >30).

The epidemiology of knee osteoarthritis may vary depending on population studied, but some general patterns have been observed. According to a March 2024 study, worldwide prevalence of knee osteoarthritis above 40 years of age was 22.9% and for above 15 years of age it was 16.0%. According to a 2020 study, globally 10% - 20% of population have knee pain among which 80% experience reduced range of motion and 20% of population are unable to perform daily living activities. Assistance in basic daily activities is required by 11% of knee osteoarthritis patients.

Knee osteoarthritis is commonly divided in two types. They are primary osteoarthritis and secondary osteoarthritis. 

1.  Primary osteoarthritis is the most common type seen in elderly people due to wear and tear degeneration. It is also termed as idiopathic osteoarthritis.

2.  Secondary osteoarthritis occurs due to joint injury or any change in articular cartilage or subchondral bone due to any underlying causes like metabolic or endocrine disorders, hereditary conditions, neurological conditions, post traumatic cases or due to congenital malformations.

Causes of secondary osteoarthritis includes obesity, knee fracture, trauma, infections, genu valgum or genu varum deformity, metabolic conditions like rickets, hemochromatosis, endocrine disorders like acromegaly, hyperparathyroidism, neurological conditions like diabetes, syringomyelia, excessive use of intraarticular steroid therapy.

Clinical features includes severe intermittent pain seen after activity in early stages of osteoarthritis whereas constant pain is more pronounced in advance stages of osteoarthritis, swelling and knee crepitus, muscle weakness and instability of joint, decreased range of motion of the knee joint, stiffness of knee joint mainly after rest. 

Kellgren and Lawrence scale is used for grading/staging of osteoarthritis. 

Stage 0 is absence of any abnormality. 

Stage 1 is beginning of osteoarthritis and beginning of osteophyte formation at bone ends. 

Stage 2 is moderate narrowing of joint space and subchondral sclerosis. 

Stage 3 is more than 50% narrowing of joint space, more pronounced subchondral sclerosis and osteophyte formation. 

Stage 4 is chracterized by destruction of joint, loss of joint space and subluxed position.

NEED OF THE STUDY

Osteoarthritis is a chronic progressive degenerative disease of synovial joints of multifactorial etiology characterized by inflammation, cartilage erosion and osteophytes formation resulting in pain and decreased functional activity. It is one of the common cause of disability worldwide. Proprioceptive exercises are used to improve proprioceptive responses that are generally impaired in knee osteoarthritis patients. Strengthening exercises helps to maintain the strength of weakened muscles. All these exercises thereby helps in reducing pain, stiffness and improving functional ability in knee osteoarthritis patients. Ultrasound therapy is a form of high frequency current that helps in reducing pain and is easy to use. Different therapeutic approaches have been developed for treating knee osteoarthritis such as Maitland mobilization, Mulligan mobilization, muscle energy technique, proprioceptive exercises, strengthening exercises. Though various studies showed that proprioceptive exercises, strengthening exercises and ultrasound therapy are effective for reducing pain and stiffness and increasing functional ability in knee osteoarthritis patients, but there is less evidence to document the efficacy of proprioceptive exercises over strengthening exercises and vice-versa in long term management plan. Hence, the purpose of this study is to find the effectiveness of proprioceptive exercises versus strengthening exercises with common use of ultrasound therapy in patients with osteoarthritis of knee.

OBJECTIVE OF THE STUDY

To evaluate the effectiveness of proprioceptive exercises along with UST in patients with osteoarthritis of knee. 

To evaluate the effectiveness of strengthening exercises along with UST in patients with osteoarthritis of knee. 

To compare the effectiveness between proprioceptive exercises and strengthening exercises along with UST in patients with osteoarthritis of knee. 

HYPOTHESIS

NULL HYPOTHESIS (H0)

There will be no significant difference between the effectiveness of proprioceptive exercises and strengthening exercises with the common use of UST among patients with osteoarthritis of knee.

ALTERNATIVE HYPOTHESIS (H1)

There will be significant difference between the effectiveness of proprioceptive exercises and strengthening exercises with the common use of UST among patients with osteoarthritis of knee. 

METHODOLOGY

30 patients with osteoarthritis of knee will be selected based on selection criteria by convenient sampling. They will be allocated into two groups, Group A and Group B. Each group will have 15 patients. Group A will receive proprioceptive exercises along with UST and Group B will receive strengthening exercises along with UST. The initial values will be checked by Western Ontario and McMaster Universities Arthritis Index (WOMAC). After 4 weeks of intervention these parameters will be assessed again. Intra group (paired t test) and inter group (independent t test) analysis will be done to find out which of the interventions are more effective.

Group A will perform following proprioceptive exercises. 

1. One leg balance in which patient will stand on one affected leg maintaining relaxed upright posture and the other leg will be flexed at hip, knee and ankle. Patient will hold this position for 1 minute followed by 10-20 seconds of rest and after that two more repetitions will be carried out. Patient will perform 3 similar repetitions for another leg. 

2. Blind advanced one leg balance in which patient will stand on one affected leg maintaining relaxed upright posture and the other leg will be flexed at hip, knee and ankle with his/her eyes completely closed. Patient will hold this position for 1 minute followed by 10-20 seconds of rest and after that two more repetitions will be carried out. Patient will perform 3 similar repetitions for another leg.  

3. Toe walking in which patient will walk 20 meters on toes with toes pointing straight ahead, then will walk with toes pointing outwards and then with toes pointing inwards. Patient will perform this for 1 more repetition. 

4. Heel walking in which patient will walk 20 meters on heels with toes pointing straight ahead, will walk on heels with toes pointing out and then with toes pointing in. Patient will perform this for 1 more repetition.   

5. Cross leg body swing in which patient will lean slightly forward with hands on wall for support and weight on one affected leg while the other leg will swing in front of body with toes pointing upwards as foot reaches the farthest point of motion and then patient will swing back this leg as far as comfortably possible. Patient will perform this for 15 repetitions. After a few seconds of rest patient will perform similar 15 repetitions with another leg as the weight bearing limb.

Group B will perform following strengthening exercises.

1. Static quadriceps in knee extension in which patient will be in supine position. Patient will contract the quadriceps femoris muscle while pushing the knee down and maintaining full dorsiflexion of foot. Each contraction will be hold for 6 secs with 10 secs of rest between the repetitions. 

2. Standing terminal knee extension in which patient will be in standing position with holding a resistive band behind a slightly flexed knee. Patient will contract the gluteal muscle and quadriceps femoris muscle to fully extend the hip and knee. Each contraction will be hold for 3 seconds. Resistance will be increased according to patient’s tolerance. 

3. Seated leg press in which patient will be seated holding a resistive band with both the hands. Patient will place his/her foot against the band, then will extend the knee by pushing the foot down and forward by contracting the gluteal and quadriceps femoris muscles. Patient will hold each contractions for 3 seconds with knee as straight as possible and then will slowly return to the starting position.

Both group A and group B will receive ultrasound therapy continuous mode, 1 MHz frequency, 1.5W/cm2 intensity for 10 minutes.

EXPECTED OUTCOME

Both the groups are expected to show improvement with the intervention of 4 weeks. However whether they are statistically significant and if there will be any difference between the two interventions remains to be seen. 

 

 

 

 

 

 
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