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CTRI Number  CTRI/2011/06/001851 [Registered on: 30/06/2011] Trial Registered Retrospectively
Last Modified On: 26/01/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   ROLE OF NERVE MOVEMENT EXERCISES IN NECK AND ARM PAIN  
Scientific Title of Study   EFFECTIVENESS OF NEURAL MOBILIZATION TECHNIQUES IN NEUROGENIC CERVICOBRACHIAL PAIN SYNDROME.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RANGANATH GANGAVELLI 
Designation  Assistant Professor 
Affiliation  INDIAN ASSOCIATION OF PHYSIOTHERAPISTS 
Address  DEPARTMENT OF PHYSIOTHERAPY, MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY
5/1, End point flats, KMC quarters, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  09844372252  
Fax    
Email  ranga980@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RANGANATH GANGAVELLI 
Designation  Assistant Professor 
Affiliation  INDIAN ASSOCIATION OF PHYSIOTHERAPISTS 
Address  DEPARTMENT OF PHYSIOTHERAPY,MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY
5/1, End Point Flats, KMC Quarters, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  09844372252  
Fax    
Email  ranga980@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RANGANATH GANGAVELLI 
Designation  Assistant Professor 
Affiliation  INDIAN ASSOCIATION OF PHYSIOTHERAPISTS 
Address  DEPARTMENT OF PHYSIOTHERAPY,MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY
5/1, End Point Flats, KMC Quarters, Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  09844372252  
Fax    
Email  ranga980@gmail.com  
 
Source of Monetary or Material Support  
MANIPAL UNIVERSITY 
 
Primary Sponsor  
Name  Nil 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
nil    
Nil   
 
Countries of Recruitment    
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
RANGANATH GANGAVELLI  DEAPRTMENT OF PHYSIOTHERAPY  Room no 208, MANIPAL COLLEGE OF ALLIED HEALTH SCIENCES,A H S BUILDING-576104
Udupi
KARNATAKA 
09844372252

ranga980@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MANIPAL UNIVERSITY ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  NEUROGENIC CERVICOBRACHIAL PAIN SYNDROME,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONVENTIONAL PHYSIOTHERAPY  Group -1 :Intermittent cervical traction, Hydrocollator packs for neck and Interferential therapy followed by Home exercise programme 
Intervention  NEURAL TISSUE MOBILIZATION  Group-2 : Conventional therapy as described earlier and Ipsilateral neural tissue mobilization Group-3: Conventional therapy as described earlier and Ipsilateral remote neurodynamics + Ipsilateral neural tissue mobilization  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)DIAGNOSED MECHANICAL NECK PAIN OR NEUROGENIC CERVICOBRACHIALPAIN SYNDROME,

2)POSITIVE UPPER LIMB NEURAL TISSUE PROVOCATION TEST FOR MEDIAN NERVE 
 
ExclusionCriteria 
Details  1)NEGATIVE SPURLINGS TEST,

2)CONTRAINDICATIONS TO MANUAL PHYSICAL THERAPY TECHNIQUES,

3)DIAGNOSED CERVICAL INSTABILITIES OR MYELOPATHY 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
NUMARICAL PAIN RATING SCALE,
ELBOW EXTENSION RANGE OF MOTION DURING UPPER LIMB NEURAL TISSUE PROVOCATION TESTING FOR MEDIAN NERVE,
 
 
Secondary Outcome  
Outcome  TimePoints 
1)NORTHWICK PARK NECK PAIN QUESTIONNAIRE

2)H-RELLEX LATENCIES,
VIBRATION THRESHOLDS. 
1)8

2)2 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/06/2010 
Date of Study Completion (India) 09/04/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The aim of this study is to determine the effectiveness of neural tissue mobilization techniques in managing neurogenic cervicobrachial pain syndrome. Hence the subjects with neck and arm pain will be screened for inclusion and exclusion criteria of the study. Informed consent will be obtained from those subjects who meet the criteria. These subjects will be allocated to one of the three groups through stratified block randomozation. subjects allocated to Group 1 will receive conventional therapy, group 2 will receive Conventional therapy + Ipsilateral upper limb neural tissue mobilization and group 3 will receive conventional therapy + Neural tissue mobilisation with remote sequencing.

Neumeric pain rating Scale, H-reflex latency of Flexor carpi radialis, Vibration thresholds and   North wick park neck pain questionnaire are considered as outcome measures which will be collected preintervention and at discharge.

 
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