| CTRI Number |
CTRI/2025/04/085324 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of neural mobilization in individuals with low back pain |
|
Scientific Title of Study
|
Effectiveness of neurodynamic mobilization on knee proprioception and foot pressure in low back pain with sciatica – A pilot 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 |
Hariharan S |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
PT 22, 4th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003117497 |
| Fax |
|
| Email |
hs2925@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs R Karthiga |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.15, 5th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9972520614 |
| Fax |
|
| Email |
karthigr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs R Karthiga |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no.15, 5th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district, Tamilnadu, India 603203
Room no.15, 5th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9972520614 |
| Fax |
|
| Email |
karthigr@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Phyiotherapy,SRM Institute of science and technology,Kattankulathur,Kancheepuram,Tamil Nadu,India -603 203 |
|
|
Primary Sponsor
|
| Name |
Hariharan S |
| Address |
PT 22, 4th floor, SRM college of physiotherapy, SRM medical college building, SRM Institute of Science and Technology, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Hariharan S |
SRM medical college hospital and research centre |
Room no.20, outpatient department physiotherapy unit, 1st floor, SRM medical college hospital and research centre, Kattankulathur,Chengalpattu district, Tamilnadu, India 603203
Kancheepuram
TAMIL NADU |
9003117497
hs2925@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interferential Therapy |
Interferential Therapy (IFT) will be given using Technomed Electronics (VECTROSTIM-100) brand. The IFT consists of dual channels, 3.5 kg weight, 4000 Hz frequency, and 220 volts.
DURATION: 15 MINUTES |
| Intervention |
NEURODYNAMIC MOBILIZATION |
Therapist Position: Stride standing
Patient Position: Supine lying
This is a hands-on, exercise-based technique designed to mobilize nerve roots that may be causing nerve root pain. To perform distal mobilization, the patient lies on their back while the practitioner dorsiflexes the ankle and flexes the hip with the knee extended. The leg is raised until reaching the “barrier” the point where tension is first sensed. The foot is then alternated between plantar flexion and dorsiflexion in repeated cycles.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Both Men and Women.
2.Participants diagnosed clinically with the Low Back Pain with Sciatica till the level of ankle
3.Participants who are diagnosed with proprioception deficits by using Joint Position Reproduction (JPR) test.
4.Grade A and B lumbar stenosis based on MRI report.
|
|
| ExclusionCriteria |
| Details |
1.Any knee joint related surgery, deformity or injury.
2.Those who are taking other treatment for sensory and motor deficits of knee joint.
3.Those who are undergoing training or treatment related to knee joint.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Joint Position Reproduction (JPR)
2.OHM 3000 plantar pressure system
|
BASELINE AND END OF THE 4TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Joint Position Reproduction (JPR)
2.OHM 3000 plantar pressure system
|
END OF THE 4TH WEEK |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
19/05/2025 |
| 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
|
The subjects will be selected based on the inclusion and exclusion criteria. The purpose of the study will be clearly explained in their regional language and ‘Informed consent’ will be obtained from the subjects. A sample size of 10 will be selected. The participants will be divided into two groups. Group A - 5 Participants will receive Neurodynamic Mobilization and Conventional treatment. Group B - 5 Participants will receive Interferential Therapy. The treatment sessions will be given 3 times per week for a total of 12 sessions over 4 weeks. The pre-test and post-test examination will be taken. Statistical analysis will be done to find out effectiveness of the treatment protocol. |