| CTRI Number |
CTRI/2019/07/020373 [Registered on: 26/07/2019] Trial Registered Prospectively |
| Last Modified On: |
25/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Fear of movement, Magnification of pain and X-ray findings in Osteoarthritis of Knee |
|
Scientific Title of Study
|
Association between Kinesiophobia, Pain Catatrophizing and Radiographic findings in Osteoarthritis of Knee-A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Singh N |
| Designation |
Post graduate student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College of Physiotherapy orthopedic opd , number 5
SDM College of Physiotherapy orthpedic
opd , number 5
Dharwad
KARNATAKA
580009
India |
| Phone |
09591034219 |
| Fax |
|
| Email |
radhikasingh0417@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant B Mukkanavar |
| Designation |
Professor |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College of Physiotherapy orthopedic opd , number 5
SDM College of Physiotherapy orthopedic opd , number 5
Dharwad
KARNATAKA
580009
India |
| Phone |
09036981180 |
| Fax |
|
| Email |
drprashantmb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant B Mukkanavar |
| Designation |
Professor |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College of Physiotherapy orthopedic opd , number 5
SDM College of Physiotherapy orthopedic opd , number 5
Dharwad
KARNATAKA
580009
India |
| Phone |
09036981180 |
| Fax |
|
| Email |
drprashantmb@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Physiotherapy Manjushreenagar Sattur Dharwad |
|
|
Primary Sponsor
|
| Name |
Radhika Singh N |
| Address |
SDM College of Physiotherapy Manjushreenagar Sattur Dharwad |
| 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 |
| Radhika Singh N |
SDM College of Medical Sciences and Hospital |
Department of Orthopaedic Physiotherapy OPD
NO 5
SDM College of Medical Sciences and Hospital Manjushreenagar Sattur Dharwad
Dharwad
KARNATAKA |
09591034219
radhikasingh0417@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitinal Ethics Committee Permission |
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 |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who agreed to sign the informed consent form.
2. Subjects with an age group 45-70 years.3,4
3. Either gender.
4. Subjects should be diagnosed with Knee Osteoarthritis by the orthopaedician.
5. Should be having Knee Radiographs referred by the orthopaedician.
|
|
| ExclusionCriteria |
| Details |
1. Subjects not willing to participate in the study.
2. Subjects with any other neurological, cardiovascular problems
3. Any history of knee and lower limb surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tampa Scale of Kinesiophobia
Pain Catastrophizing Scale
|
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale (NPRS)
Hand Held Dynamometer
WHO Quality of Life-BREF Questionnaire
6 minute walk test |
baseline |
|
|
Target Sample Size
|
Total Sample Size="327"
Sample Size from India="327"
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)
|
28/07/2019 |
| 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
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| To date, Radiographic findings of knee OA is always used as a demographic variable and studies have tried to examine if it is a predictor for assessing disability in OA patients. No studies have been done to compare the association between kinesiophobia, pain catastrophizing and KL grades 0-4 of knee OA.Finally, it is unknown how important KL grades of knee OA are in explaining variations in objective measures of knee extensor strength and functional performance and Quality of Life of the study subjects. Understanding the relative importance of kinesiophobia and pain catastrophizing in KL grades of knee OA is that, it may help focus on the psychosocial assessment in OA patients and could have implications for treatment interventions in different grades of knee OA related to the pain related cognitions. Hence the strong need arises to assess the association between kinesiophobia, pain catastrophizing and radiographic findings in osteoarthritis of knee. | |