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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
Intervention / Comparator Agent
|
|
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. |