CTRI Number |
CTRI/2019/02/017840 [Registered on: 27/02/2019] Trial Registered Prospectively |
Last Modified On: |
22/02/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
A study to compare the individual and combined effect of nerve flossing technique and intermittent lumbar traction on Pain and disability in lumbar radiculopathy patients. |
Scientific Title of Study
|
A study to compare the individual and combined effect of nerve flossing technique and intermittent lumbar traction on P1 and P2 angle of SLR,Pain and disability in lumbar radiculopathy patients-a comparative study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Riddhi shah |
Designation |
1st year M.P.T. Resident |
Affiliation |
Government physiotherapy college,Jamnagar |
Address |
Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Jamnagar GUJARAT 361008 India |
Phone |
8511550551 |
Fax |
|
Email |
riddhishah1605@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Karishma jagad |
Designation |
Senior lecturer |
Affiliation |
Government physiotherapy college,Jamnagar |
Address |
Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Jamnagar GUJARAT 361008 India |
Phone |
9374141991 |
Fax |
|
Email |
Karishmadodia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Riddhi shah |
Designation |
1st year M.P.T. Resident |
Affiliation |
Government physiotherapy college,Jamnagar |
Address |
Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Exercise and electrotherapy department of Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar Jamnagar GUJARAT 361008 India |
Phone |
8511550551 |
Fax |
|
Email |
riddhishah1605@gmail.com |
|
Source of Monetary or Material Support
|
Government physiotherapy college,Jamnagar |
|
Primary Sponsor
|
Name |
Government physiotherapy collegeJamnagar |
Address |
Government physiotherapy college,In old T.B. hospital,
Rameshwarnagar,
Jamnagar |
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 |
Riddhi Shah |
Government physiotherapy college,Jamnagar |
1.P1 and P2 angle of SLR
2.Modified Oswestry Disability Index Jamnagar GUJARAT |
8511550551
riddhishah1605@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
M.P.Shah govt. medical college and Guru Gobindsingh Hospital Jamnagar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G570||Lesion of sciatic nerve, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
1. Intermittent lumbar traction
2. Nerve flossing technique |
1. Intermittent lumbar traction is a modality which provides distraction force between two vertebrae and unload the spinal structures.
2. Nerve flossing,a type of neural mobilization,is an active non-invasive healing procedure |
Comparator Agent |
1.Visual analogue scale
2.P1 and P2 angle of SLR
3.Oswestry Disability Index |
1.It is a pain rating scale.
2.SLR neurodynamic test results in hip flexion range of motion and symptom intensity.
3.it is commonly used back functional scale. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Involvement of l4,l5,S1,S2 nerve root pain radiating to one or both legs.
2.Patients with positive SLR and SLUMP test.
3.Patients with acute or sub-acute stage duration of symptoms < 12 weeks.
4.All subjects with Oswestry disability index score >20% |
|
ExclusionCriteria |
Details |
1.Any spinal conditions in which movement are contraindicated
2.Acute sprain,strain and inflammation or any painful symptoms aggravated by treatment
3.Rheumatoid arthritis
4.Tumours or infections like TB of spine
5.Malignancy
6.Pregnancy
7.Uncontrolled Hypertension
8.Patients with congenital deformity
9.Non cooperative patients
10.Participants with cervical spine pathology |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Visual analogue scale
|
After 5 days and at the end of 2 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.P1 and P2 angle of SLR
2.Modified Oswestry Disability Index |
After 5 days and 2 weeks |
|
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)
|
15/03/2019 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet done |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Lumbar radiculopathy (often known as Sciatica) refers to the symptoms of pain, tingling, numbness or weakness that travel down the low back and into the leg or extremity.The use of lumbar traction is to unload the spinal structures by using the vertebral seperation. The nerve flossing technique is a neural mobilization technique which actually moves the nerve through the tissues from both ends which leads to less nerve excursion. the following interventions individually and also their comparision and finding the best method for treatment.
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