| CTRI Number |
CTRI/2021/03/031739 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of severity and disability of pain with scapula posture in neck pain patients. |
|
Scientific Title of Study
|
Correlation of severity and perceived disability of pain with scapula posture in neck pain patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavana Mhatre |
| Designation |
Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEMH |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEM Hospital, Acharya Dhonde Marg, Parel East, Mumbai -12, Mumbai (suburban)
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821712963 |
| Fax |
|
| Email |
28bhavanamhatre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavana Mhatre |
| Designation |
Professor |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEMH |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEMH, Acharya Dhonde Marg, Parel East, Mumbai -12, Mumbai (Suburban)
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821712963 |
| Fax |
|
| Email |
28bhavanamhatre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Sawant |
| Designation |
Master of Physiotherapy student |
| Affiliation |
P.T. School and Centre, Seth G.S. Medical College and KEMH |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEMH, Acharya Dhonde Marg, Parel East, Mumbai -12, Mumbai (suburban)
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9766733396 |
| Fax |
|
| Email |
snehalsawant8495@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.T. School and Centre, Seth G.S. Medical College and KEMH |
|
|
Primary Sponsor
|
| Name |
Bhavana Mhatre |
| Address |
P.T. School and Centre, Seth G.S. Medical College and KEMH, Acharya Dhonde Marg, Parel East, Mumbai 400012 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bhavana Mhatre |
P.T. School and Centre, Seth G.S. Medical College and KEMH |
401, Physiotherapy OPD, Ground floor, Kem Orthopedic Centre, Acharya Dhonde Marg, Parel (E)
Mumbai
MAHARASHTRA |
9821712963
28bhavanamhatre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Seth G.S. Medical College and KEMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with some degree of neck pain |
|
| ExclusionCriteria |
| Details |
1)Congenital deformities of scapula
2)Cervical radiculopathy or myelopathy
3)Previous history of whiplash injury or any other cervical trauma
4)Previous history of cervical spine surgery
5)Presence of widespread pain i.e. fibromyalgia syndrome
6)Any infective, inflammatory or neoplastic condition of neck
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck pain severity (numerical pain rating scale)
Perceived disability ( Neck disability Index)
Scapula Posture (Lennies test, Acromion to plinth distance) |
one time assessment of outcome measures at baseline for each participant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
scapula posture (on observation)
degree of forward head posture ( CV Angle) |
one time assessment of outcome measures at baseline for each participant |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
12/03/2021 |
| 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="0"
Months="6"
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
|
Neck pain is a major musculoskeletal disorder. One of the commonest poor head posture seen in neck pain patients is forward head posture. As the forward head posture increases, severity and disability of neck pain also increases. Neck and scapula share some common muscle attachments. Hence, scapula posture might be affected in neck pain patients. Following study will help us to find out if the severity and disability of neck pain is affected by altered scapula posture. Severity of pain and disability will be assessed using Numerical pain rating scale and Neck disability index, respectively. Scapula posture will be assessed using Lennie’s test and acromion to plinth distance. This is an observational correlational type of study which will require 20 minutes per participants. Data will be analysed using Pearson’s correlation coefficient to find out correlation between severity and disability of pain and scapula posture in neck pain patients. |