| CTRI Number |
CTRI/2024/02/062527 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of physical activity levels, specific body measurements like height, weight, BMI, body fat index, and sociodemographic details with the severity of knee pain |
|
Scientific Title of Study
|
Association of physical activity levels, anthropometric and sociodemographic variables among knee pain subjects: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaini Gala |
| Designation |
Post Graduate student (Master of Physiotherapy) |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Second Floor, Room no 3, Kasturba Medical College Hospital, Attavar, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7506426807 |
| Fax |
|
| Email |
jaini.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar Circle, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish John Prabhakar |
| Designation |
Assistant Professor- Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar Circle, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Hospital, Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy, Fifth floor, Kasturba Medical College Hospital, Umbedkar Circle, Mangalore, Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Jaini Gala |
Kasturba Medical College Hospital |
Department of Physiotherapy, Second floor, Room no. 3, Kasturba Medical College Hospital, Attavar, Mangalore, Karnataka-575004, India
Dakshina Kannada
KARNATAKA |
7506426807
jaini.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18-45 years having knee pain and having any of the following symptoms:
recurrent pain and swelling, pain following a duration of inactivity, pain during any activity |
|
| ExclusionCriteria |
| Details |
Any recent or acute injury to musculoskeletal structures of the lower
limbs (less than 3 months).
Any individual with diagnosed vestibular dysfunction, psychological
disorders, or pregnant women.
Any individual who has undergone surgery in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global Physical Activity Questionnaire (GPAQ): to assess physical activity
Karada Bioelectrical Impedance Analyzer Omron HBF 375: to assess body composition, specifically body fat and muscle mass.
Visual Analogue Scale (VAS): to assess the severity of knee pain.
|
The above mentioned outcome measures will be assessed only at the baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
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
|
The study title is Association of Physical Activity Levels, anthropometric and sociodemographic variables among knee pain subjects: A cross-sectional study. The study aims to find the association of physical activity level, anthropometric and sociodemographic variables with the severity of knee pain in subjects with chronic knee pain. Participants aged 18 to 45 years fulfilling the inclusion criteria would be assessed for pain using the Visual Analogue Scale, physical activity levels using the Global Physical Activity Questionnaire, and Body fat levels using a Bioelectrical impedance analysis machine. Data will be subjected to statistical analysis. |