| CTRI Number |
CTRI/2025/09/094946 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lumbar Lordosis, Pelvic Stability and Physical Activity among with Non-Specific low Back Pain |
|
Scientific Title of Study
|
Relationship Between Lumbar Lordosis, Pelvic Stability and Physical Activity among Patients with Non-Specific 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 |
Theertha C P |
| Designation |
Postgraduate |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University Road, Dertakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7736841046 |
| Fax |
|
| Email |
theerthasanthosh21@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nigath Fathima |
| Designation |
Associate professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University Road, Dertakatte, Mangaluru
Dakshina Kannada KARNATAKA 575018 India |
| Phone |
7406225106 |
| Fax |
|
| Email |
fathimanigat@yenepoya.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Nigath Fathima |
| Designation |
Associate professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, University Road, Dertakatte, Mangaluru
KARNATAKA 575018 India |
| Phone |
7406225106 |
| Fax |
|
| Email |
fathimanigat@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya university (deemed to be university) Yenepoya Physiotherapy College , Deralakatte, Mangaluru , Dakshina Kannada Karnataka India 575018 |
|
|
Primary Sponsor
|
| Name |
THEERTHA C P |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Theertha C P PT |
Yenepoya Medical College and Hospital |
Yenepoya Medical College and Hospital 7th Floor Physiotherapy Department And Orthopedics ward Floor no 1 Dakshina Kannada KARNATAKA |
7736841046
theerthasanthosh21@gmail.com |
| THEERTHA C P |
Yenepoya Medical College and Hospital |
Yenepoya Medical college hospital, physiotherapy department 7th floor, OPD, Ortho ward first floor university road deralakatte mangaluru karnataka India Dakshina Kannada 575018 Dakshina Kannada KARNATAKA |
07736841046
theerthasanthosh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M404||Postural lordosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) History of non-specific low back pain
b)Age group 18-50 years
c)Participants with no pathological musculoskeletal constraints
|
|
| ExclusionCriteria |
| Details |
a)Pelvic or hip pathology, other pelvic related dysfunction individuals
b)Recent surgery
c)Recent acute injury
d)Exclude older age group
e)Individuals who uses assistive devices or orthosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
International physical activity questionnaire
Magnetic resonance imaging (MRI)
Prone plank test and close kinematic chain test |
5 points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2025 |
| 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 is a cross-sectional design aimed at investigating the relationship
between lumbar lordosis, pelvic stability, and physical activity among patients
with non-specific low back pain (NSLBP). The study will utilize imaging
techniques such as X-rays and MRI to assess lumbar lordosis and pelvic
alignment, along with functional assessments like the prone plank test to
evaluate core stability and endurance. Participants will include individuals
diagnosed with NSLBP, recruited through convenience sampling from a clinical or
community setting. Inclusion and exclusion criteria will be applied, and
informed consent will be obtained prior to participation. Lumbar lordosis
angles will be measured through standardized radiological imaging protocols.
Pelvic stability will be assessed using dynamic and static biomechanical tests,
while physical activity levels will be evaluated through questionnaires. The
prone plank test will measure core endurance, which will serve as a functional
indicator of pelvic and lumbar stability. The data will be analyzed to explore
the correlation between lumbar lordosis, pelvic stability, and physical
activity levels. Gender-specific and age-specific analyses may also be
performed. The study aims to provide insights into biomechanical and functional
factors contributing to NSLBP, potentially guiding targeted interventions to
improve lumbar-pelvic stability and physical activity for better management of
NSLBP. |