| CTRI Number |
CTRI/2025/07/090215 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying how different positions during the Straight Leg Raise test affect how fast signals travel through the sciatic nerve in people with leg pain due to nerve compression. |
|
Scientific Title of Study
|
Effect of the different sensitizers of Straight leg Raise on conduction velocity characteristics of sciatic nerve in individuals with sciatica using NCV parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
| Address |
Room no.6,Neuro OPD Physiotherapy department,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Mandal |
| Designation |
Postgraduate Student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9547954791 |
| Fax |
|
| Email |
abhishekmandal53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Mandal |
| Designation |
Postgraduate Student |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana
HARYANA
133207
India |
| Phone |
9547954791 |
| Fax |
|
| Email |
abhishekmandal53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.6,Neuro OPD-Functional diagnostic lab Physiotherapy department,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana-133207 , India. |
|
|
Primary Sponsor
|
| Name |
Abhishek Mandal |
| Address |
Room no.6,Neuro OPD-functional diagnostic lab, Physiotherapy department,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana-133207,India |
| 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 |
| DrAbhishek Mandal PT |
Department Of Physiotherapy |
Room no.6,Neuro OPD-Functional diagnostic lab ,Physiotherapy department,Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana-133207,India.
Ambala
HARYANA |
9547954791
abhishekmandal53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Maharishi Markandeshwar Institute of Medical sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
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 |
Age 18-45 years.
Both males and females.
Individuals with a combination of sciatic symptoms and clinical findings of sciatica
A positive SLR at clinical examination
Radiating pain to lower limb either below or above the knee
|
|
| ExclusionCriteria |
| Details |
Individuals with metabolic disorders like (diabetes, hyperthyroidism)
Individuals with progressive neurological deficits
Individuals SI joint dysfunction or any hip pathology
Individuals with spinal Tumor or malignancy
Individuals with metabolic bone disease such as rheumatoid arthritis
Age more than 65 years or younger than 18 years
Individuals refusal to give informed consent to participate
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nerve Conduction Velocity
Visual Analogue Scale |
Assessed at the baseline at the time of the recruitment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion |
Assessed at the time of recruitment measured at the baseline of recruitment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/07/2025 |
| 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="1"
Months="0"
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
|
Background: The straight leg raise (SLR) is the most commonly applied physical test on patients with sciatica. When performing SLR, different sensitizers like Hip internal rota-tion-adduction and ankle dorsiflexion tensions the sciatic nerve along its course. As nerve conduction velocity (NCV) increases with stretch in myelinated nerves. Through which we can identify the most sensitive sensitizer of Straight Leg Raise which may increase the mechano-sensitivity and conduction velocity of the nerve using nerve conduction parame-ters, thereby helping the clinician to select the particular sensitizer for neural testing Purpose: To find out the efficacy to investigate the sensitive position in SLR that subjects the Sciatic nerve to excessive stress using NCV parameters Methods: Patients will be recruited according to established selection criteria. Then straight leg raise (SLR) was done with in 3 different sensitizers like SLR with neck flexion, SLR with hip adduction and internal rotation and SLR with ankle dorsiflexion. Then on MNCV and NPRS will be evaluated of SLR with different sensitizers. Data Analysis: Data will be analyzed using the Statistical Package for Social Sciences (SPSS) software.
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