| CTRI Number |
CTRI/2024/09/073990 [Registered on: 17/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Reducing pain and improving movement by sliding the sciatic nerve in people with lowerback and leg problems. |
|
Scientific Title of Study
|
Sciatic nerve glides on pain and function in patients with lumbosacral radiculopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bivya liss saju |
| Designation |
PG Resident(MPT) |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
MPT 2nd year classroom
MPT division
Physiotherapy Department
Yenepoya Physiotherapy College
Naringana,Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7025790798 |
| Fax |
|
| Email |
bivyasaju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariyamath Arifa |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Staffroom
Staff division
Physiotherapy Department
Yenepoya Physiotherapy College
Naringana,Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8123111672 |
| Fax |
|
| Email |
arifamariyam.am@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bivya liss saju |
| Designation |
PG resident (MPT) |
| Affiliation |
Yenepoya Physiotherapy college |
| Address |
MPT 2nd year classroom
MPT division
Physiotherapy Department
Yenepoya Physiotherapy College
Naringana,Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7025790798 |
| Fax |
|
| Email |
bivyasaju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self source,
Yenepoya Medical College
Hospital(YMCH)
Yenepoya Ayurveda Medical College And Hospital (YAMCH) |
|
|
Primary Sponsor
|
| Name |
Bivya Liss Saju |
| Address |
Yenepoya Physiotherapy College
Naringana,
Deralakatte
Mangalore-575018
Dakshina Kannada
KARNATAKA
India
|
| Type of Sponsor |
Other [Self funded ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bivya Liss Saju |
Yenepoya Ayurveda Medical College and hospital |
Physiotherapy Department
physiotherapy division -4th floor
Kollarakodi
Naringana
Mangalore-575018
Dakshina Kannada
KARNATAKA |
7025790798
bivyasaju@gmail.com |
| Bivya Liss Saju |
Yenepoya Medical College and hospital |
Physiotherapy Department
Physio division 7th floor
Deralakatte
Mangalore-575018
Dakshina Kannada
KARNATAKA |
7025790798
bivyasaju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G541||Lumbosacral plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core strengthening exercises |
Core strengthening exercises like neutral spine, curl up,cat -camel,Bird -dog and supine bridge. group will receive 50 minutes of core strengthening exercises each exercise 10 repetitions for 10 minutes. |
| Intervention |
Sciatic nerve gliding exercises |
Nerve gliding exercises which consist of sliding and tensioning techniques.The sliding technique is performed by extending the affected leg with neck extension and for the tensioning the neck is flexed along with knee extension.Along with these core strengthening exercises are given.Experimental group will receive 25 min of nerve gliding exercises and 25 minutes of core strengthening exercises (each exercise 5 repetitions).consists of 9 sessions of therapy for 3 weeks.Total time of the study will be 50 minutes. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. unilateral radiating lower extremity pain, tingling or numbness for more than 2months
2.Age 25-55 years
3. patients who have diagnosed with lumbosacral radiculopathy based on MRI
4. Normal range of cervical spine |
|
| ExclusionCriteria |
| Details |
1.Congenital anomaly of spinal column
2.Spinal instability
3.Previous spinal surgery or lower limb surgery
4.Pathological history of cervical spine
5.Peripheral neuropathy including diabetes mellitus
6.Impaired cognition
7.Severe osteoarthritis and osteoporosis
8.Tuberculosis,tumor, inflammation around the nervous system and spinal cord.
9.Spondylolisthesis
10.Recent fracture involving spine and lower limbs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Oswestry low back pain disability questionnaire |
outcomes will be assessed at the baseline and after 3 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Lumbosacral radiculopathy.is a condition which is caused mainly due to irritation or compression of the nerve roots of lumbar and sacral region. Radiculopathy results in pain, muscle weakness and functional disability. Neural mobilization is a series of techniques used to evaluate and re-establish the nerve’s elasticity and mobility. This study aims to evaluate the effectiveness of sciatic nerve glides on pain and functional disability in patients with lumbosacral radiculopathy. It is a randomized controlled trial. A total of 30 participants will be allocated into two groups- experimental and control group. Experimental group will be receiving sciatic nerve glides along with core-strengthening exercises and control group will be given core strengthening exercises alone. Numerical pain rating scale and Oswestry low back pain disability questionnaire will be used as outcome measures to assess the pain and functional disability in patients with lumbosacral radiculopathy. The study duration is going to be for 3 weeks and outcome measures will be measured at pre and post treatment. Data will be analyzed using Paired-t test to assess the variable within the group. Independent sample t-test will be used to assess in-between group comparison. |