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CTRI Number  CTRI/2023/02/049647 [Registered on: 13/02/2023] Trial Registered Prospectively
Last Modified On: 09/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Comparison of fear of movement,pain intensity, depression, function and self confidence between males and females in chronic knee osteoarthritis 
Scientific Title of Study   Gender Differences in Kinesiophobia, Pain Intensity, Depression, Function and Self Efficacy in Individuals with Chronic Knee Osteoarthritis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namrata S Kamble 
Designation  Post graduate student 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India
SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India
Dharwad
KARNATAKA
580009
India 
Phone  9535342702  
Fax    
Email  kamblenamrata.007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Namrata S Kamble 
Designation  Post graduate student 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India
SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India

KARNATAKA
580009
India 
Phone  9535342702  
Fax    
Email  kamblenamrata.007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Kulkarni 
Designation  Professor 
Affiliation  SDM College of Physiotherapy 
Address  SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India
SDM College of Physiotherapy, Manjushree nagar, sattur Dharwad Karnataka 580009 India
Dharwad
KARNATAKA
580009
India 
Phone  9886276543  
Fax    
Email  dr.shweta07@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Physiotherapy Manjushree nagar Sattur Dharwad 
 
Primary Sponsor  
Name  Namrata S Kamble 
Address  SDM College of Physiotherapy Manjushree nagar Sattur Dharwad Karnataka 580009 India 
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 
Namrata S Kamble  SDM College of Medical Science and Hospital  Department of orthopaedic physiotherapy OPD No 5 SDM College of Physiotherapy Manjushree nagar Sattur Dharwad 580009 India
Dharwad
KARNATAKA 
9535342702

kamblenamrata.007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee SDM Colllege of Medical Sciences and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age more than 45 years or older
2. Subjects with chronic knee osteoarthritis
3. Subjects of either gender
4. Subjects having movement-related joint pain.19
5. Either no morning knee stiffness or stiffness of 30 min or less.19
6. Subjects who are willing to participate in the study and to complete
the questionnaires. 
 
ExclusionCriteria 
Details  1. History of cardiovascular, neurological or orthopedic problems that
could affect the patients activity of daily living
2. Previous knee surgery on the affected side in the last 6 months.
3. Injection to the knee joint during last 6months.
4. Individuals with cancer, epilepsy, psychiatric disorders, arthritis
other than osteoarthritis
5. Presence of co-existing chronic pain conditions other than knee pain
6. Subjects who are unwilling to participate and cannot read and write. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale(VAS)
ï‚· TAMPA scale of Kinesiophobia(TSK)
ï‚· The Knee Injury and Osteoarthritis Outcome Score
(KOOS)

ï‚· Hospital Anxiety and Depression scale (HADS)
ï‚· General Self Efficacy Scale(GSES) 
single time 
 
Secondary Outcome  
Outcome  TimePoints 

Visual analogue scale(VAS)
TAMPA scale of Kinesiophobia(TSK)
The Knee Injury and Osteoarthritis Outcome Score
(KOOS)

Hospital Anxiety and Depression scale (HADS)
General Self Efficacy Scale(GSES) 
single time 
 
Target Sample Size   Total Sample Size="526"
Sample Size from India="526" 
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)   15/02/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
OA is a clinical problem related to pain, it has been clinically noted that there is a significant inflammatory soft tissue contribution to the severity and frequency of OA pain. OA is one of the most frequent causes of chronic pain, at the initial stage the pain at the OA joint occurs during movements and loading of the joint, which is increased during activities. At the later stages, the pain seems to occur even during nights and without loading the joint or performing the movements. Thus, it is noted that there is gradual increase of pain with OA progression. As the condition becomes chronic patients will avoid physical activity due to fear of movement and worsening of pain. Various scales and/or questionnaires are used to measure pain intensity, kinesiophobia, depression, self efficacy and quality of life. The commonly used outcome measures in chronic knee osteoarthritis is The Knee Injury and Osteoarthritis Outcome Score (KOOS), which is used to assess patients opinion about their knee and associated problems. Visual analogue scale (VAS) is a valuable instrument used to assess pain intensity and changes due to therapy when respondents are given good instructions and the limitations are borne in mind. Hospital Anxiety and Depression scale (HADS) consists of anxiety and depression subscales which is easy, simple and reliable generic self reported tool. General Self Efficacy Scale is used to assess the strength of individual’s belief in his or her own ability to respond to difficult situation and to deal with any associated obstacles. Tampa scale of Kinesiophobia is used to assess fear and phobia in individuals with musculoskeletal pain. Individuals with chronic musculoskeletal pain conditions, like OA avoid to perform the daily physical activities that are been motivated by fear of pain rather than the actual pain. Pain is more over accepted as a key symptom of knee OA, and is not correlated with OA related structural changes. Kinesiophobia in patients with knee OA is been reported to increase the rate of disability. It is a central factor in the pain process which develops from acute to chronic stages. Kinesiophobia is referred to as a psychological fear, which is secondary to the bodily damage that is caused by activities of daily living, when the patient is worried about pain. It is determined that when a painful experience is interpreted as threatening, they can generate catastrophizing cognitions which results in more pain and re-injury. The common symptoms seen in knee OA are pain, stiffness, swelling, muscle weakness, crepitation, locking sensation, decrease range of motion and deformity. Knee OA negatively affects daily life by causing deterioration in the function and quality of life. And also, patient with knee OA has a significant impact on the psychological factors like Kinesiophobia, Depression, Catastrophizing, Anxiety etc. In long term pain due to the negative effects on pain and function, Kinesiophobia and pain catastrophizing decreases the efficiency of treatment and patient satisfaction. Kinesiophobia has been studied in number of conditions such as chronic low back pain, chronic fatigue syndrome, and shoulder pain and even in elderly populations. It is been found that level of pain and pain related fear are significantly associated with functional limitations in patients with OA. A study done by Elboin-Gabyzon and his colleagues on gender difference in terms of pain perception and functional ability in OA knee patients has concluded that though the prevalence of OA knee in females is higher but still they had lower functional abilities compared to male subjects. The reason for this was stated as the self reported measures were influenced by psychological factors of chronic pain like catastrophizing, depression and self efficacy in females. In spite of the higher prevalence of knee  OA among females because of estrogen hormone during and post menopause, gender-related differences among patients with knee OA have received little attention. Also, there is dearth of literature in relation to gender difference amongst various symptoms of chronic pain in OA knee. Hence, there exist a need to compare the pain intensity, function and psychological symptoms in Males and Females in OA of Knee.
 
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