| CTRI Number |
CTRI/2018/03/012352 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of spine mobilization with nerve movement versus effect of spine mobilisation with arm movement |
|
Scientific Title of Study
|
Effect of neurodynamic SNAGs versus spinal mobilization with arm movements in subjects with cervical radicupathy:A randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Dilip kurode |
| Designation |
Post graduate |
| Affiliation |
Kle institute of Physiotherapy,belgavi |
| Address |
Block no 3,shivneri galli,shahu Nagar Belagavi
Kle campus,kles institute of Physiotherapy,nehru Nagar Belgavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9503741603 |
| Fax |
|
| Email |
kurodeshivani@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Associate professor |
| Affiliation |
Kle institute of Physiotherapy,belgavi |
| Address |
Shivbasav Nagar belgavi
Kle campus,kles institute of Physiotherapy,nehru Nagar Belgavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandhegs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Dilip kurode |
| Designation |
Post graduate |
| Affiliation |
Kle institute of Physiotherapy,belgavi |
| Address |
Block no 3,shivneri galli,shahu Nagar Belagavi
Kle campus,kles institute of Physiotherapy,nehru Nagar Belgavi
Belgaum
KARNATAKA
590001
India |
| Phone |
9503741603 |
| Fax |
|
| Email |
kurodeshivani@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Kle institute of Physiotherapy,Kle campus nehru Nagar belgavi |
|
|
Primary Sponsor
|
| Name |
Kle institute of Physiotherapy |
| Address |
Kle institute of Physiotherapy,nehru Nagar belgavi |
| 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 |
| Shivani Kurode |
Dr.prabhakar Kore charitable hospital,belgavi |
Kle campus,nehru Nagar belgavi
Orthopaedic manual therapy department, Physiotherapy opd.
Belgaum
KARNATAKA |
9503741603
0831-2493777
kurodeshivani@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cervical radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A(neurodynamic SNAGs group) given for 6 days |
Subjects in sitting position ,therapist delivered the snags on affected vertebrae with keeping affected upper limb in neurodynamic test position |
| Comparator Agent |
Group B(spinal mobilization with arm movement) |
Therapist give glide to the affected vertebrae and patients has to do offending movement of the upper limb in either flexion, extension, abduction. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.radiating pain from neck to upper limb more than 3 weeks with(any of the 3 positive)spurling test,cervical distraction test, ipsilateral side rotation less than 60 degrees, positive upper limb neurodynamic test(ULTT)
2.subjects willing to participate in the study. |
|
| ExclusionCriteria |
|
|
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 |
| VAS,NDI, cervical range of motion |
VAS,NDI, cervical range of motion will be assessed at first day before enrollment in the study and then after 6 sessions of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS,NDI and cervical ROM |
It was assessed at the time of enrollment and then after 6 sessions of intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2017 |
| Date of Study Completion (India) |
04/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A study was conducted on effect of neurodynamic SNAGs versus spinal mobilization with arm movement in subjects with cervical radicupathy:a randomized clinical trial with 32 subjects,17 in group A (neurodynamic SNAGs )and 15 in group B(spinal mobilization with arm movement)with VAS,NDI,CRom as outcome measures which where taken on first day of recruitment and 6 day after intervention.In the results it shows intra group statistical significant difference but no statistical significant difference was found intergroup.This concludes that both the groups are equally effective in treating cervical radicupathy patients. |