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CTRI Number  CTRI/2024/05/066643 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Cervical Spine HVT Manipulation in Weight Bearing and Non-weight Bearing Position on Pain and Range of Motion. 
Scientific Title of Study   Immediate and follow up effects of cervical spine manipulation in weight bearing and non weight bearing position on neck pain and range of motion in mechanical neck pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SIDDHI TUKARAM SANKHE 
Designation  PG student 
Affiliation  Dr. D .Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9021623635  
Fax    
Email  sidhasankhe9991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SIDDHI TUKARAM SANKHE 
Designation  PG student 
Affiliation  Dr. D .Y. Patil College of Physiotherapy, Pune 
Address  Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9021623635  
Fax    
Email  sidhasankhe9991@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurang Baxi  
Designation  Professor 
Affiliation  Dr. DY Patil College of physiotherapy 
Address  Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Pimpri, Pune.

Pune
MAHARASHTRA
411018
India 
Phone  9371007824  
Fax    
Email  gaurangbaxi82@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil college of physiotherapy, 3rd floor, Dept. of cardiorespiratory physiotherapy, sant tukaram nagar, pimpri, pune 411018 
 
Primary Sponsor  
Name  Siddhi Tukaram Sankhe 
Address  Dr. D. Y. Patil College of Physiotherapy, Cardiorespiratory Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Pimpri, Pune. 
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 
Dr Siddhi Sankhe  Dr. D. Y. Patil college of physiotherapy  Cardiorespiratory Physiotherapy Department, 3rd floor, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA 		 09021623635

sidhasankhe9991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Dr. D. Y Patil College of Physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  mechanical neck pain  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1) Weight Bearing Cervical spine High Velocity Thrust Manipulation  A single Cervical spine High Velocity Thrust Manipulation will be given in weight bearing position. Conventional exercises will be given along with this, for total of 4 consecutive days.   
Comparator Agent  Nil  NA 
Intervention  Non-Weight Bearing Cervical spine High Velocity Thrust Manipulation  A single Cervical spine High Velocity Thrust Manipulation will be given in non-weight bearing position. Conventional exercises will be given along with this, for total of 4 consecutive days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) Age between 18-30 years.
2) Neck Pain [NPRS score between 3-6]
3) Both genders
 
 
ExclusionCriteria 
Details  1) Any history of cervical spine fracture.
2) Any major trauma in the past (car accident or an head injury).
3) Patient refusal or worsening of symptoms with previous manipulation.
4) Vertigo, Nerve damage, cord compression, paralysis patient.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Neck pain using Numerical pail Rating Scale (NPRS)
2) Cervical Spine Range of motion
3) Neck disability index [NDI] 		 1) Beginning of study
2) After 4 days of intervention
3) Follow up assessment after 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   Phase 1 
Date of First Enrollment (India)   15/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Sending and email to PI

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
·Cervical thrust manipulation is known to be effective in reducing neck pain.
·However, there is no clear evidence weather any specific approach towards manipulation is more effective over the others.
·Hence, this study proposes to explore the immediate effects of cervical thrust manipulation in weight bearing and non-weight bearing positions on pain and range of motion in individuals with mechanical neck pain.
·Further, the long term retention effects of the treatment given will also be explored.
 
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