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CTRI Number  CTRI/2022/11/047304 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 06/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Reliability and Validity of Upper Extremity Functional Index in patients with Chronic Neck Pain 
Scientific Title of Study   Measurement Properties of the Upper Extremity Functional Index in Patients Presenting with Chronic 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  Assisstant Professor  
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth GSMC and KEM Hospital, Acharya Dhonde Marg, Parel (East)

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dipti Geete 
Designation  Assisstant Professor  
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth GSMC and KEM Hospital, Acharya Dhonde Marg, Parel (East)

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  dipti_geete@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dipti Geete 
Designation  Assisstant Professor  
Affiliation  PT School and Centre, Seth GS Medical College and KEM Hospital 
Address  PT School and Centre, Seth GSMC and KEM Hospital, Acharya Dhonde Marg, Parel (East)

Mumbai
MAHARASHTRA
400012
India 
Phone  02224143435  
Fax    
Email  dipti_geete@yahoo.com  
 
Source of Monetary or Material Support  
PT School and Centre, Seth GS Medical College and KEM Hospital, Parel (East), Mumbai-400012 
 
Primary Sponsor  
Name  Dipti Geete 
Address  PT School and Centre, Seth GSMC and KEM Hospital, Parel (East), Mumbai-400012 
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 
Dipti Geete  KEM Hospital  Physiotherapy OPD, PT School and Centre, Seth GS Medical College and KEM Hospital, Acharya Dhonde Marg, Parel (East), Mumbai-400012
Mumbai
MAHARASHTRA 		 02224143435

dipti_geete@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Seth GSMC and KEMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with chronic neck pain. 
 
ExclusionCriteria 
Details  1. History of cervical trauma
2. Cervical myelopathy
3. History of cervical spine surgery
4. Infections or inflammatory pathology involving cervical spine
5. Systemic conditions like fibromyalgia and uncontrolled diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Upper Extremity Functional Index  3-4 times 
 
Secondary Outcome  
Outcome  TimePoints 
1.Neck Disability Index
2.Disability of Arm, Shoulder and Hand  		 3-4 times 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   20/11/2022 
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 extremely common and can result from several musculoskeletal
diagnoses. Neck pain not only affects the patient’s ability to perform tasks that involve
movement of the spinal column, but also affects the tasks that demand optimal upper
extremity functions. Traditionally, physical therapists have assessed disability in chronic neck
pain (CNP) patients using Neck Disability Index (NDI), which is a 10-item outcome measure
designed to assess the impact on neck functions. However, no outcome measure that is
designed to assess the impact on upper extremity functions has been tested for its utility in
CNP patients.

Objective: The proposed study is aimed at assessing the measurement properties of the
Upper Extremity Functional Index (UEFI) in patients with CNP. In particular, the study will
examine the test-retest reliability, concurrent validity and responsiveness for the UEFI in
patients presenting to an outpatient physical therapy clinic with CNP.

Methods: Patients presenting with CNP to the physiotherapy OPD of KEM Hospital will be
approached for participation in the study. Subjects will be chosen as per the inclusion and
exclusion criteria and informed written consent will be taken. The purpose and procedure of
the study will be explained to all subjects in detail in the language they understand. If
participants agree to participate in the study, they will undergo assessment at different time
points. Sociodemographic data (Case Record Form) will be assessed. All data will be
collected by registered physical therapists. The data collected will be analysed statistically.
Clinical Relevance: It is well-understood that patients with CNP experience disability in
upper extremity functions as well. However, current physical therapy assessment
approaches do not address the measurement of upper extremity disability in these patients.
The proposed research will determine whether the Upper Extremity Functional Index (UEFI),
a very common measure for assessing upper extremity disability, is useful in assessing upper
extremity disability in patients with CNP.

 
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