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CTRI Number  CTRI/2018/04/013088 [Registered on: 06/04/2018] Trial Registered Prospectively
Last Modified On: 07/02/2020
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   Comparison of two treatment techniques for neck pain. 
Scientific Title of Study   Comparison of Immediate Effects of Cervicothoracic Junction Mobilization with Thoracic Manipulation on Range of Motion and Pain in Patients with Mechanical 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  Shriya Joshi 
Designation  1st Year MPT Orthopaedics student 
Affiliation  School of Allied Health Sciences, MAHE 
Address  Department of Physiotherapy, School of Allied Health Sciences, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9834888964  
Fax    
Email  joshishriya27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ganesh Balthillaya M 
Designation  MPT Orthopaedics and Sports  
Affiliation  School of Allied Health Sciences, MAHE 
Address  Department of Physiotherapy, School of Allied Health Sciences, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9448263631  
Fax    
Email  ganesh.bm@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Shriya Joshi 
Designation  1st Year MPT Orthopaedics student 
Affiliation  School of Allied Health Sciences, MAHE 
Address  Department of Physiotherapy, School of Allied Health Sciences, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9834888964  
Fax    
Email  joshishriya27@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital,Madhav Nagar, Manipal 576104. Karnataka, India 
 
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 
Shriya Joshi  Kasturba Hospital.  Department of physiotherapy, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 
9834888964

joshishriya27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC & KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mechanical Neck Pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cervicothoracic Junction Mobilization  Direction specific mobilization to cervicothoracic junction according to primary movement restriction. Grade of glides will be decided on basis of severity, irritability & nature of pain. 3-5 sets of 30 sec bouts will be given  
Comparator Agent  NIL  NIL 
Intervention  Thoracic Thrust Manipulation  Patient lies in prone. Zygapophyseal joints will be marked on both sides. Subject performs deep inhalation & exhalation. At end of exhalation, screw thrust technique will be performed. If popping sound not heard, technique will be repeated again. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with primary complaint of neck pain, having cervicothoracic junction hypomobility
Moderate to severe intensity of pain (more than or equal to 4/10 on NPRS) 
 
ExclusionCriteria 
Details  Recent significant trauma
Radiculopathy
Myelopathy
Malignancy
Severe Headaches
Fractures of spine or upper limbs
Metabolic disease
History of cervical or thoracic spine surgery 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cervical Range of Motion with CROM device  Before allocation of group
Half an hour after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Pain intensity on NPRS  Before allocation of group
Half an hour after intervention 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/04/2018 
Date of Study Completion (India) 27/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Mechanical neck pain is a common complaint in today’s computer driven lifestyle. Spinal (cervical and thoracic) mobilization/manipulation is commonly used by physiotherapists in treatment of mechanical neck pain.
In cases with severe intensity of pain, mobilization directly over involved segment may not be possible due to pain provocation. Hence there is need to mobilize other adjacent segments.
There is limited literature on mobilization of cervicothoracic junction when compared with thoracic manipulation in mechanical neck pain.
Hence aim of this study is to compare immediate effects of CT junction (C7-T1) mobilization over mid-thoracic (T3-T7) manipulation on cervical range of motion & pain in patients with mechanical neck pain.
Study will be done on patients with primary complaint of neck pain, having CT junction hypomobility, who have moderate-severe intensity of pain. Participants will be randomized into either cervicothoracic junction mobilization group or thoracic manipulation group. Range of motion & pain will be assessed after 1 treatment session to find effectiveness of intervention.
The study may help in selection of better treatment in cases where severe pain prevents direct mobilization of involved segments.
 
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