| CTRI Number |
CTRI/2025/02/080240 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of exercises for Nerve and muscles at the back of the thigh on pain and daily activities in people with low back pain |
|
Scientific Title of Study
|
Effectiveness of sciatic nerve neurodynamic interventions in addition to hamstring stretching on pain and function among individuals with mechanical low back pain-A pilot randomized control 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 |
Shishir Regmi |
| Designation |
principle investigator |
| Affiliation |
Gitam School of Physiotherapy, GITAM(Deemed to be university) |
| Address |
Demo room no 1, 4th Floor, GITAM School of Physiotherapy, GITAM (Deemed to be university)- Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh
GIMSR campus,Rushikonda, visakhapatnam -530045, India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8810394650 |
| Fax |
|
| Email |
shishirregmi92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranganath Gangavelli |
| Designation |
Guide |
| Affiliation |
Professor, GITAM school of physiotherapy, GITAM(Deemed to be university) |
| Address |
Principal office, 4th Floor, GITAM School of Physiotherapy, GITAM (Deemed to be university)- Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh
GIMSR campus,Rushikonda, visakhapatnam -530045, India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9844372252 |
| Fax |
|
| Email |
shishirregmi92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shishir Regmi |
| Designation |
principle investigator |
| Affiliation |
GITAM school of physiotherapy, GITAM(Deemed to be university) |
| Address |
Demo room no 1, 4th Floor, GITAM School of Physiotherapy, GITAM (Deemed to be university)- Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh
GIMSR campus,Rushikonda, visakhapatnam -530045, India
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8810394650 |
| Fax |
|
| Email |
shishirregmi92@gmail.com |
|
|
Source of Monetary or Material Support
|
| GIMSR Hospital, GITAM Medical College Rd, Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh 530045 |
|
|
Primary Sponsor
|
| Name |
Gitam (Deemed to be university) |
| Address |
Gandhi Nagar, Rushikonda, Visakhapatnam, Andra pradesh 530045 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRanganath Gangavelli |
GIMSR hospital |
Room NO.1, Department of physiotherapy, GIMSR, Visakhapatnam
Visakhapatnam
ANDHRA PRADESH |
9844372252
rgangave@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMSR Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hamstring static stretching,Core strengthening, isometric abdominals and spinal extensors exercises with pelvic bridging and pelvic tilting exercises |
Hamstring static stretching will be given to both the groups for 4 sets of 25-30 seconds hold for 6 sessions over two weeks.
The other exercises will be given for 3 sets of 8-10 repetitions for 6 sessions over 2 weeks |
| Intervention |
Sciatic nerve Neurodynamics, Hamstring static stretching Core strengthening, isometric abdominals and spinal extensors exercises with pelvic bridging and pelvic tilting exercises |
The sciatic nerve neurodynamic sliders and tensioners will be given to only one group, for 3 sets of 5-10 repetitions for 6 sessions over 2 weeks.
Hamstring static stretching will be given to both the groups for 4 sets of 25-30 seconds hold for 6 sessions over two weeks.
The other exercises will be given for 3 sets of 8-10 repetitions for 6 sessions over 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with mechanical low back pain,
associated hamstring tightness,
sedentary lifestyle
|
|
| ExclusionCriteria |
| Details |
Pregnant women,
Bilateral symptoms (sacroiliac, hip and knee joint pathologies),
low back pain with sensory motor deficits,
Diabetes Mellitus or polyneuropathies,
Low back pain of non mechanical origin (Neoplasm, visceral, referred, vascular and inflammatory origin.) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Numeric pain Rating Scale (NPRS) |
2 times in the beginning and at the end of the study
(pre and post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Passive Knee Extension |
2 times in the beginning and at the end of the study
(pre and post intervention) |
| Oswestry Disability Index |
2 times in the beginning and at the end of the study
(pre and post intervention) |
| Straight leg raise |
2 times in the beginning and at the end of the study
(pre and post intervention) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/02/2025 |
| 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
|
This pilot study is a randomized, parallel group, active control trial comparing the effectiveness of sciatic nerve neurodynamic interventions in addition to hamstring stretching on pain and function among 30 individuals with mechanical low back pain and associated hamstring tightness. This will be conducted in GIMSR hospital ,GITAM (deemed to be University) over a span of 5 months. The primary outcome measures would be NPRS (for pain) and secondary outcome measures would be Oswestry Disability Index for low back pain and passive knee extension for hamstring flexibility. |