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CTRI Number  CTRI/2021/04/033225 [Registered on: 29/04/2021] Trial Registered Prospectively
Last Modified On: 28/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of neck joint position sense in patients with neck pain and diabetes mellitus  
Scientific Title of Study   Evaluation of cervical proprioception in patients with neck pain and diabetes mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SOHANI MADHURA SANTOSH 
Designation  MPT student  
Affiliation  KMC Manipal university Mangalore 
Address  Physiotherapy department KMC Bejai Mangalore

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9623421551  
Fax    
Email  madhura.sohani@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charu Eapen  
Designation  Professor and Head of the department of physiotherapy 
Affiliation  Kasturba Medical College Mangalore 
Address  Physiotherapy department 1st floor KMC Bejai Mangalore

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9986024551  
Fax    
Email  charu.eapen@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Charu Eapen  
Designation  Professor and Head of the department of physiotherapy 
Affiliation  Kasturba Medical College Mangalore 
Address  Physiotherapy department 1st floor KMC Bejai Mangalore

Dakshina Kannada
KARNATAKA
575003
India 
Phone  9986024551  
Fax    
Email  charu.eapen@manipal.edu  
 
Source of Monetary or Material Support  
KMC Mangalore 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Ms Madhura Sohani  KMC Mangalore   Physiotherapy Department KMC hospital Nandigudda Road Attavar Mangalore 575001
Dakshina Kannada
KARNATAKA 		 9623421551

madhura.sohani@yahoo.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having neck pain and between age group of 30 to 60 years will be recruited. Out of them patients having DM will be selected for case group. Last HbA1c report and self-reported diabetic status will be collected.
The following definition of neck pain will be allowed:
"Pain perceived anywhere in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process". - The International Association for The Study of Pain (IASP)
• Cervical Spondylosis
• Discogenic Pain
• Non-specific neck pain
"Pain located in the anatomical region of the neck with or without radiation to the head, trunk, and upper limbs". - Task Force on Neck Pain
 
 
ExclusionCriteria 
Details  1. History of neurologic disorder
2. Whiplash injury
3. Vestibular dysfunction
4. Tumours involving the cervical spine
5. Cognitive impairment
6. Thoracic Outlet Syndrome
7. Cervical Myelopathy
8. Cervical Instability
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Joint position error
neck pain intensity
neuropathy  		 Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Neck pain intensity
Neuropathy 		 Baseline 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/04/2021 
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    
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 assess joint position error in subjects with neck pain and subjects with Neck pain and DM. 

There exist plausible mechanisms by which cervical proprioception can be impaired secondary to DM. Such impairment of cervical proprioception can increase the vulnerability of the cervical spine and surrounding soft tissues to injuries. The affection of cervical proprioception will also compromise the feedback regarding head position and have detrimental consequences on posture. Chronic faulty postures can result in mechanical stress on the cervical spine, impair the optimum length of surrounding soft tissues and further lead to neck pain. As a result, detecting any correlation between cervical proprioception and DM becomes necessary to optimize outcomes in the management of neck problems in patients with diabetes. 

The study includes an assessment of Joint Position Error (JPE) by using Cervical Range of Motion Unit (CROM) which is completely safe for patient and involves active range of motion.

If proprioception is more affected in patients with DM and neck pain, better preventive or management strategies can be design to reduce or prevent neck pain and improve JPE and contribute to less impairment of posture. 


 
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