| CTRI Number |
CTRI/2025/07/090261 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Neurodynamic slider on Gait Parameters i lumbar canal stenosis related to neuropathic pain. |
|
Scientific Title of Study
|
Effect of passive Neurodynamic Slider on Gait parameters in Subject with Lumbar Canal Stenosis Related to Neuropathic pain.: - A Sham Randomized Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soumya Ranjan Lenka |
| Designation |
MPT Scholar |
| Affiliation |
Abhinav bindra sports medicine and research institute. |
| Address |
room no. 01,Abhinav bindra sports medicine and research institute, NH-16,plot no 273,pahala, bhubaneswar
Khordha
ORISSA
752101
India |
| Phone |
7978659818 |
| Fax |
|
| Email |
soumyalenka03srl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Ranjan Lenka |
| Designation |
MPT Scholar |
| Affiliation |
Abhinav bindra sports medicine and research institute. |
| Address |
room no. 01,ABSMARI, NH-16,plot no 273,pahala, bhubaneswar
Khordha
ORISSA
752101
India |
| Phone |
7978659818 |
| Fax |
|
| Email |
soumyalenka03srl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Ranjan Lenka |
| Designation |
MPT Scholar |
| Affiliation |
Abhinav bindra sports medicine and research institute. |
| Address |
room no. 01,Abhinav bindra sports medicine and research institute, NH-16,plot no 273,pahala, bhubaneswar
room no. 01, ABSMARI, NH-16, plot no 273, pahala, bhubaneswar
Khordha
ORISSA
752101
India |
| Phone |
7978659818 |
| Fax |
|
| Email |
soumyalenka03srl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Niramaya Optima Clinic, Plot no- L/3-145, Acharya Vihar, Bhubaneswar, Khorda, pincode- 751013 |
|
|
Primary Sponsor
|
| Name |
Soumya Ranjan Lenka |
| Address |
room no. 01, ABSMARI, NH-16, Plot no. 273, Pahala, Bhubaneswar- 752101 |
| 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 |
| Soumya Ranjan Lenka |
Abhinav bindra sports medicine and research institute |
Room number 01,Abhinav bindra sports medicine and research institute, Department of physiotherapy, NH-16,plot no 273,pahala, bhubaneswar
Khordha
ORISSA |
07978659818
soumyalenka03srl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABSMARI ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Passive Neurodynamic Slider Technique |
Here the subject is positioned on their side-lying, with their gaze in a horizontal plane. The upper leg is kept steady at 0 degrees of hip flexion, with the knee extended and resting on a cushion in contact with the plinth. The therapist positions the lower leg at 20 degrees of hip
flexion and 0 degrees of hip abduction, with the knee extended. The therapist then passively moves the patients leg into 70-80 degrees of
hip flexion while maintaining 0 degrees of hip abduction. During this movement, the patient is instructed to actively extend their upper
cervical spine by "looking up." |
| Comparator Agent |
Sham Neurodynamic Slider Technique |
Here the subject were positioned on the border of the plinth, lying on the side opposite to their most symptomatic side. In this side-lying position, the patients gaze remained in a horizontal plane, and the upper leg was kept stedy at 0 degrees of hip flexion, with knee extended, resting on a cushion in contact with the plinth. The mobilisation was performed on the less symptomatic side, starting with 15 degrees of hip flexion, 20 degrees pf abduction and full knee extension, while the patient maintained a horizontal gaze. The therapist then passively moved the patients leg to 30 30 degrees of hip flexion, ensuring the abduction was maintained throughout the technique, while the patient was instructed to actively extend the upper cervical spine. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Lower Extremity or Lower Extremity Predominant radiating pain to Lower extremity.
DN4 Questionnaire (more than 4).
Previous Magnetic Resonance Imaging (MRI) confirming lumbar spinal stenosis. |
|
| ExclusionCriteria |
| Details |
Participants with history of any previous lumbar surgery that included fusion, spinal injection in the last 6 weeks, Participants with impaired walking due to any other comorbid
conditions.
Participants with inability to follow the instructions.
Participants with having any medical contraindication for hip movement
or any current medico-legal issues. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sagittal Kinematic parameter (segmental angle, segmental acceleration)
10-meter Walk test. |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index low back Pain Index Scale |
4 week |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/07/2025 |
| 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="0"
Months="1"
Days="15" |
|
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
|
Lumbar spinal stenosis is a prevalent disorder that affects older adults caused by narrowing of lumbar spinal and nerve root canal thus leading to compression of the neural and vascular structures within the spaces thus experiences a difficulty in walking and standing. Neuropathic pain occurs when there is a involvement of nerve and nerve root, thus creating disruption in their normal gait patterns thus having increased gait variability. Neurodynamic slider reinstate the dynamic balance between relative movement of neural tissues and surrounding mechanical interfaces, hence promote optimal physiological function thus resulting in reducing gait variability. Two groups will be consider i.e. experimental group and sham group, in which the experimental group will receive passive neurodynamic slider and sham group will receive sham neurodynamic slider. The intervention will be given for 4 weeks after which post data of outcome measure will be taken, before the intervention the pre assessment and outcome measure data will be taken. Based on the data of outcome measures the data analysis will be done and after that result & discussion will be written followed by conclusion. The main objective is to investigate the effect of passive neurodynamic slider technique on gait parameters in subject with lumbar spinal stenosis associated with neuropathic pain. |