| CTRI Number |
CTRI/2025/07/091380 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pelvic alignment on sciatic nerve sensitivity in healthy young men |
|
Scientific Title of Study
|
The influence of pelvic alignment on sciatic nerve mechanosensitivity response in healthy adult males |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biswajeet Sethi |
| Designation |
Student |
| Affiliation |
Alvas college of physiotherapy and research centre |
| Address |
ALVA’S COLLEGE OF PHYSIOTHERAPY
AND RESEARCH CENTRE
MOODBIDRE, DK, KARNATAKA
Alvas college of physiotherapy and Research Centre outpatient physiotherapy department Alvas health centre road Mudbidri Karnataka
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9668831366 |
| Fax |
|
| Email |
biswajeet.20016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas college of physiotherapy and research centre |
| Address |
Alvas college of physiotherapy and Research Centre outpatient physiotherapy department Alvas health centre road Mudbidri Karnataka
Dakshina Kannada
Karnataka
574227
India
Alvas college of physiotherapy and Research Centre outpatient physiotherapy department Alvas health centre road Mudbidri Karnataka
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Biswajeet Sethi |
| Designation |
Student |
| Affiliation |
Alvas college of physiotherapy and research centre |
| Address |
ALVA’S COLLEGE OF PHYSIOTHERAPY
AND RESEARCH CENTRE
MOODBIDRE, DK, KARNATAKA
lvas college of physiotherapy and Research Centre outpatient physiotherapy department Alvas health centre road Mudbidri Karnataka
Dakshina Kannada
Karnataka
574227
India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9668831366 |
| Fax |
|
| Email |
biswajeet.20016@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Biswajeet Sethi |
Alvas college of physiotherapy and research centre |
outpatient physiotherapy department Alvas health centre road mudbidri, Karnataka 574227 Dakshina kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9668831366
biswajeet.20016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic healthy adult males with pelvic alignment variations |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Male |
| Details |
Healthy males with any pelvic alignment normal or misalignment and full pain free lower limb range of motion |
|
| ExclusionCriteria |
| Details |
individuals with lower limb deformities, inflammatory or neurological conditions, spinal pain any history of trauma or radiating pain or any sensory and motor deficits |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pelvic alignment angles sagittal and frontal measured by PALM palpation meter |
15mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sciatic nerve mechanosensitivity measured by SLR tests |
15mins |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
24/08/2025 |
| 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="5"
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 aim of study to evaluate the influence of pelvic alignment on sciatic nerve mechanosensitivity in healthy adult males aged 20–29 years. Pelvic alignment will be measured using the PALM palpation meter for sagittal and frontal planes, and sciatic nerve mechanosensitivity will be assessed using Straight Leg Raise (SLR) neurodynamic tests (SLR 1, SLR 2, SLR 4). The study will include 74 asymptomatic males with or without pelvic misalignment, recruited from Alva’s College of Physiotherapy OPD, Moodbidri. By analyzing the relationship between pelvic position and neural responses, the study seeks to establish normative data on neural mechanosensitivity in healthy individuals, which may aid early identification of neuromechanical alterations and inform preventive physiotherapy interventions. |