| CTRI Number |
CTRI/2024/08/071995 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Fear Of Physical Activity Due To Chronic Low Back Pain Among Adults In Indian Population |
|
Scientific Title of Study
|
Fear Avoidance Beliefs For Physical Activity Among Adults In Indian Population With Chronic Low Back Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHAVARAJ R |
| Designation |
Post graduate student |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of science and technology |
| Address |
Room no:Pt05 5th floor SRM College Of Physiotherapy SRM Institute Of Science And Technology SRM Nagar Potheri Kattankulathur Chengalpattu District Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010983893 |
| Fax |
|
| Email |
madhavampv20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yasmeen Imtiaz |
| Designation |
Assistant professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of science and technology |
| Address |
Room no:Pt05 5th floor SRM College Of Physiotherapy SRM Institute Of Science And Technology SRM Nagar Potheri Kattankulathur Chengalpattu District Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500182105 |
| Fax |
|
| Email |
yasmeeng@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MADHAVARAJ R |
| Designation |
Post graduate student |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of science and technology |
| Address |
Room no:Pt05 5th floor SRM College Of Physiotherapy SRM Institute Of Science And Technology SRM Nagar Potheri Kattankulathur Chengalpattu District Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7010983893 |
| Fax |
|
| Email |
madhavampv20@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1.Physiotherapy outpatient department 1st floor SRM medical college hospital and research centre SRM nagar potheri kattankulathur chengalpattu district pin 603203 Tamilnadu India
|
|
|
Primary Sponsor
|
| Name |
MADHAVARAJ R |
| Address |
Room no:Pt05 5th floor SRM College Of Physiotherapy SRM Institute Of Science And Technology SRM Nagar Potheri Kattankulathur Chengalpattu District Tamilnadu pin 603203 |
| 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 |
| Dr Madhavaraj R |
SRM medical college hospital and research centre |
Physiotherapy outpatient department 1st floor SRM nagar Potheri kattankulathur Chengalpattu District Tamilnadu India
pin 603203
Kancheepuram
TAMIL NADU |
7010983893
madhavampv20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with low back pain lasting more than 3 months
2.Willing to participate |
|
| ExclusionCriteria |
| Details |
1.Cauda equina lesion
2.Malignancy
3.Infection
4.History of spinal surgeries
5.Pregnancy
6.Not willing to participate |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| fear avoidance beliefs questionnaire |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
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)
|
16/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is going to evaluate the fear avoidance beliefs for physical activity among adults in Indian population with chronic low back pain Individuals will be selected for the study based on the inclusion and exclusion criteria the study will be clearly explained in patient words and an informed consent will be obtained individuals will be asked to fill their socio demographics then individuals will be asked to complete the self reported fear avoidance beliefs questionnaire for physical activity in addition patients who are all working population is also advised to fill up the fear avoidance beliefs questionnaire for work subscale after the data collection the data will be subjected to statistical analysis and finally the result of the study will be revealed |