| CTRI Number |
CTRI/2026/01/101803 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of nerve flossing technique on pain, functional ability, and nerve function in patients with sciatica due to proplased intervertebral disc. |
|
Scientific Title of Study
|
Efficacy of Nerve flossing technique in pain,functional disability, lumbar range of motion, nerve mobility, muscle strength and nerve conduction velocity (NCV) in the management for sciatica patients with PIVD. |
| 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 Kumari |
| Designation |
Post Graduate student |
| Affiliation |
SGT University |
| Address |
D 645 WARD NO 15 OM ENCLAVE AGWANPUR AMARNAGAR
Faridabad HARYANA 121003 India |
| Phone |
9990633297 |
| Fax |
|
| Email |
soumyasrivastava.284@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Snigdha Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9893533630 |
| Fax |
|
| Email |
snigdha_sphy@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Snigdha Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University Gurugram Haryana
Gurgaon HARYANA 122505 India |
| Phone |
9893533630 |
| Fax |
|
| Email |
snigdha_sphy@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT University, Budhera Gurugram Haryana-122505 |
|
|
Primary Sponsor
|
| Name |
Soumya Kumari |
| Address |
School of physiotherapy,SGT University, Gurugram Harayana-122505 |
| 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 |
| Dr Snigdha Tiwari |
SGT HOSPITAL |
Room no- 13, physiotherapy department, B-Block. Gurgaon HARYANA |
9893533630
snigdha_sphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institiutional Ethical Commmittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy treatment |
Strengthening exercises BIRD DOG
Pelvic tilts etc.
|
| Intervention |
Nerve Flossing Technique |
Nerve flossing technique is an alternation of combined movements of at-least two joints in which one movement lengthen the nerve bed thus increasing tension in the nerve while the other movement simultaneously decreases the length of the nerve bed which unloads the nerve. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 to 55 years
Both males and females.
positive passive straight leg test (30-70 degree).
Diagnosed as a PIVD patient by orthopaedic surgeon.
Chronic radicular pain due to PIVD. (more than 3 months).
|
|
| ExclusionCriteria |
| Details |
Lumbar spine surgery in last 12 months
Peripheral nervous system disorders
Tumour
Acute ligament injury
Pregnancy
Contraindications to mobilization (e.g., vertebral instability, fractures)
Diabetes neuropathy.
Patients reluctant to therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 PAIN
2 FUNCTIONAL DISABILITY
3 LUMBAR RANGE OF MOTION
4 NERVE MOBILITY
5 MUSCLE STRENGTH
6 NERVE CONDUCTION VELOCITY |
pre and post data for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
04/02/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [soumyasrivastava.284@gmail.com].
- For how long will this data be available start date provided 11-01-2025 and end date provided 11-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no additional information
|
|
Brief Summary
|
To determine the efficacy of nerve flossing technique in pain, functional disability, lumbar range of motion, nerve mobility, muscle strength and NCV in the management for sciatica patients with PIVD. Null hypothesis are there is no significant effect of nerve flossing technique in terms of pain reduction, functional disability improvement, muscle strength improvememnt and NCV changesin sciatica patients with pivd. Alternative hypothesis are there is significant effect of nerve flossing technique in terms of pain reduction, functional disability improvement, muscle strength improvememnt and NCV changesin sciatica patients with pivd. |