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
|
|
Primary Sponsor
|
Name |
Nil |
Address |
|
Type of Sponsor |
|
|
Details of Secondary Sponsor
|
|
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
|
|
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,
|
2 |
|
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. |