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CTRI Number  CTRI/2021/05/033445 [Registered on: 07/05/2021] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Analysis of Musculoskeletal Dysfunction and perception in subjects with Chronic Non-Specific Neck Pain  
Scientific Title of Study   To analyse the Musculoskeletal Dysfunction ,Physical Performance and Patient’s perception towards Pain and Disability in subjects with Chronic Non-Specific Neck Pain  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Physiotherapy School and Center Seth G S Medical College And K E M Hospital 
Address  OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  diptigeete123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Physiotherapy School and Center Seth G S Medical College And K E M Hospital 
Address  OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  diptigeete123@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dipti Geete 
Designation  Assistant Professor  
Affiliation  Physiotherapy School and Center Seth G S Medical College And K E M Hospital 
Address  OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  diptigeete123@gmail.com  
 
Source of Monetary or Material Support  
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 
 
Primary Sponsor  
Name  Dipti Geete 
Address  PT School and Center GS Medical College and K E M Hospital 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Bhavana Mhatre  PT School And Center, GSMC and KEM Hospital  OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012
Mumbai
MAHARASHTRA 
02224143435

us_contact@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee , Seth Gs Medical College  Approved 
Institutional Ethics Committee , Seth Gs Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Chronic non-specific neck pain 
 
ExclusionCriteria 
Details  1) History of cervical trauma /injury
2) Cervical Radiculopathy, Myelopathy, Instability
3) History of cervical spine surgery
4) Signs of Central Nervous System Affection
5) Systemic Conditions like uncontrolled diabetes mellitus, fibromyalgia,
6) Pregnancy, Fibromyalgia.
7) Infections or Inflammatory Pathologies involving the cervical Spine
8) History of psychiatric disorders or usage of antipsychotic drugs.
9) History of Acute Neck Pain 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
- Posture, Joint Position sense, balance, Cervical Endurance Test
- Neck Disability Index, Patient Specific Functional scale, Pain self Efficacy Scale.  
At the baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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)   17/05/2021 
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="2"
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  
Summary of Protocol
Nonspecific Neck pain is one of the most prevalent musculoskeletal conditions resulting in physical impairments and functional limitations. It is assumed to be a multifactorial disease. There may be dysfunction of body structure along with psychological and environmental factors that might influence the physical performance of an individual. The overall prevalence of neck pain in the general population ranges between 0.4% and 86.8% (mean: 23.1%); and 1 year prevalence ranges from 4.8% to 79.5% (mean: 25.8%). Prevalence is generally higher in women, higher in high-income countries compared with low- and middle-income countries, and higher in urban areas compared with rural areas.
Our study will be conducted by recruiting people with non-specific neck pain. Study group, which consists of 87 subjects between 18-45 years of age with non-specific neck pain. The subjects will be asses for musculoskeletal dysfunction which includes posture, balance, muscle endurance test, and proprioception. The subject’s perception towards pain and disability will be assessed by pain on NRS and through the self-reported questionnaires, for example, Neck disability index, Patient-Specific functional scale, and self– efficacy scale. Along with the above-mentioned evaluation, the subjects will be asses on the basis of the physical performance also.
The study aims to find a relationship between musculoskeletal dysfunction of the cervical spine and the patient’s perception toward pain and disability and its effect on physical performance.
 
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