| CTRI Number |
CTRI/2021/04/032657 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of traction in treatment of neck pain: A survey of Physiotherapists in India |
|
Scientific Title of Study
|
Use of cervical traction in managing neck pain: A cross-sectional survey of Physiotherapists in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Agarwal |
| Designation |
Post-graduate student |
| Affiliation |
KMC, Mangalore, MAHE |
| Address |
Kasturba Medical College, Bejai, MAHE Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
6294091063 |
| Fax |
|
| Email |
agarwalshilpa00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Patel Vivekbhai Dineshbhai |
| Designation |
Assistant Professor |
| Affiliation |
KMC, Mangalore, MAHE |
| Address |
Kasturba Medical College, Bejai, MAHE Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
vivek.patel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Agarwal |
| Designation |
Post-graduate student |
| Affiliation |
KMC, Mangalore, MAHE |
| Address |
Kasturba Medical College, Bejai, MAHE Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
agarwalshilpa00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
KMC, Mangalore, MAHE |
| Type of Sponsor |
Other [Cross-sectional survey] |
|
|
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 |
| Mr Patel Vivekbhai DineshBhai |
Kasturba Medical College, Mangalore, MAHE |
Kasturba Medical College Hospital, Department of Physiotherapy, Attavar, Mangalore
Dakshina Kannada
KARNATAKA |
8050338884
vivek.patel@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Musculoskeletal Physiotherapists in India treating patients with neck pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Musculoskeletal physiotherapists who are currently treating patients with neck pain in India. |
|
| ExclusionCriteria |
| Details |
Physiotherapists who are not currently treating patients with neck pain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Questionnaire |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| range of motion, disability |
pre intervention and post intervention |
|
|
Target Sample Size
|
Total Sample Size="375"
Sample Size from India="375"
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)
|
10/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to evaluate the use of cervical traction
for managing neck pain by Physiotherapists’ in India. Previous studies recommend
varying level of evidences for the use of traction to manage neck pain. There is a paucity of
literature about usage of traction in India: what modes and parameters the
physiotherapists commonly use and whether they use traction for specific
cervical condition(s) or its usage is generalized for all neck pain patients. The study includes providing a questionnaire to the
concerned Musculoskeletal physiotherapist who are treating patients with neck
pain. The responses will be collected and analyzed, which will conclude the practice
patterns for the use of cervical traction in managing neck pain by the
physiotherapists in India. This survey will give us information about the
practice patterns and parameters used by the physiotherapists’ in India and
whether it is in line with the current evidence-based guidelines. If not, there
is a need to incorporate the knowledge of research and guidelines to improve
the patient-related care and outcomes.
|