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CTRI Number  CTRI/2023/11/059714 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 05/03/2025
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   Osteopathic manipulation on non specific neck pain 
Scientific Title of Study   Effect of Osteopathic Manipulation on Neck Kinematics using X-Sens motion capture in Non-Specific Neck Pain: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharad Hullumani 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) 
Address  Department of Pediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha
Sawangi Meghe
Wardha
MAHARASHTRA
442004
India 
Phone  9964066927  
Fax    
Email  sharathhullumnai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghuveer Raghumahanti 
Designation  Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU),  
Address  Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha
Sawangi Meghe
Wardha
MAHARASHTRA
442004
India 
Phone  8126506769  
Fax    
Email  raghuneuro@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharad Hullumani 
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) 
Address  Department of Pediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha
Sawangi Meghe
Wardha
MAHARASHTRA
442004
India 
Phone  9964066927  
Fax    
Email  sharathhullumnai@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research (DU) 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research (DU) 
Address  Department of Physiotherapy, Acharya Vinoba Bhave Rural Hospital,Sawangi Meghe ,Wardha 
Type of Sponsor  Research institution and hospital 
 
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 Sharad Hullumani  Acharya Vinoba Bhave Rural Hospital  Room No.9, Department of Physiotherapy, Datta Meghe Institute of Higher Education and Research (DU),Sawangi Meghe.
Wardha
MAHARASHTRA 		 9964066927

sharathhullumani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,DMIHER(DU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M255||Pain in joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Osteopathic Manipulation  1.Omohyoid with upper trapezius muscle release 2. Digastric muscle release 3. Masseter muscle fascia release 4. Temporal muscle release Suprahyoid muscle traction technique 5. Suprahyoid muscle circling movement technique 6. Suprahyoid muscle pressure technique 7. Tongue unwinding technique 8. Cervical fascia release All above treatment lasting approximately 25-30 minutes, each treatment is given for 4 sessions, 5 days per week for 4 weeks and two days gap after each session. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. According to common clinical standard guidelines.
2. Both male and female
3. A history of neck pain for more than four months; a score of more than 4 out of 10 on the Visual Analogue Scale (VAS), and a score of more than 40% on Neck Disability Index (NDI).
 
 
ExclusionCriteria 
Details  1. Any neurological conditions
2. Any recent neck surgeries
3. Recent trauma
4. Any recent Physical therapy, Acupuncture, Osteopathy treatment for neck pain within 2 weeks of periods
5. Psychiatric illness, pregnancy, regular intake of corticosteroid medication, ongoing treatment with anticoagulants.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS (Visual Analogue Scale)  Baseline and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Range of motion,Joint Angles, Acceleration , Angular Velocity, Segmental Accleration  Baseline & 4th week 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   28/11/2023 
Date of Study Completion (India) 04/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/03/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 - Informed Consent Form

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharathhullumani@gmail.com].

  6. For how long will this data be available start date provided 08-08-2024 and end date provided 17-08-2028?
    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   examines the impact of osteopathic manipulation on individuals experiencing non-specific neck pain. It appears to utilize X-Sens motion capture technology to measure and analyze the kinematics of the neck during the course of the study. 
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