| CTRI Number |
CTRI/2025/07/091542 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
What participants with low back pain think about their pain.
|
|
Scientific Title of Study
|
Pain related beliefs in individuals with low back pain - 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 |
RUJULA SUNIL JADHAV |
| Designation |
Post graduate student - MPT |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, room no. 215, second floor. Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9545348313 |
| Fax |
|
| Email |
rujula.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, room no. 215, second floor. Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Kavitha Vishal |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, room no. 215, second floor. Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986526077 |
| Fax |
|
| Email |
kavitha.vishal@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rujula Sunil Jadhav self |
| Address |
Department of Physiotherapy, room no. 215, second floor. Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India - 576104 |
| 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 RUJULA SUNIL JADHAV |
Kasturba Hospital |
Department of Physiotherapy, N1, First floor, Artificial Limb Centre, Baliga block, Kasturba Hospital,Udupi-Hebri road, Madhava Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
09545348313
rujula.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants with LBP with and without radiating pain
Able to read either Kannada or English language |
|
| ExclusionCriteria |
| Details |
History of spinal surgical procedure
Recurrent LBP
Non-localised body ache
Fibromyalgia
Diagnosed Multi-joint pain
LBP due to diagnosed inflammatory and malignant conditions
Diagnosed psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain related beliefs in low back pain |
Single Time Point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="345"
Sample Size from India="345"
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)
|
03/08/2025 |
| 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="9"
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 cross-sectional study will help us to identify pain related beliefs in individuals with low back pain (LBP), and also to identify the relationship between beliefs about LBP and the pain intensity and function. To obtain this data, three questionnaires will be provided to the participants, and their demographic details will be collected. |