FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/03/017892 [Registered on: 01/03/2019] Trial Registered Prospectively
Last Modified On: 28/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Exercises for strengthening neck muscles for treatment of neck pain 
Scientific Title of Study   Effect of Proprioceptive Neuromuscular Facilitation and Cranio Cervical Flexor Training on pain and function in Chronic Mechanical Neck Pain: A Randomised Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Kuddur Suresh 
Designation  Postgraduate Student, Masters in Physiotherapy 
Affiliation  Manipal Academy Of Higher Education 
Address  Upper basement, Department of Physiotherapy, School of Allied health sciences Manipal Hospital #98 HAL Old Airport Road Bangalore Bangalore KARNATAKA 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  9620307834  
Fax    
Email  vaish14.doctor@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Prem 
Designation  HOD of department of physiotherapy at Manipal Bangalore 
Affiliation  Manipal Academy Of Higher Education 
Address  Upper basement, Department of Physiotherapy, School of Allied health sciences Manipal Hospital #98 HAL Old Airport Road Bangalore Bangalore KARNATAKA 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  8667373166  
Fax    
Email  prem.v@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Karthik Babu S PT PhD 
Designation  Associate Professor 
Affiliation  Manipal Academy Of Higher Education 
Address  Upper basement, Department of Physiotherapy, School of Allied health sciences Manipal Hospital #98 HAL Old Airport Road Bangalore Bangalore KARNATAKA 560017 India

Bangalore
KARNATAKA
560017
India 
Phone  9902338198  
Fax    
Email  karthikbabu78@gmail.com  
 
Source of Monetary or Material Support  
Manipal Hospitals Bangalore 
 
Primary Sponsor  
Name  Manipal Academy Of Higher Education 
Address  Department of Physiotherapy Manipal Hospital #98 HAL Old Airport Road Bangalore Bangalore KARNATAKA 560017 India 
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 V Prem  Manipal Hospital Bangalore  Department of Physiotherapy School of Allied health sciences Manipal Hospital #98 HAL Old Airport Road Bangalore Bangalore KARNATAKA 560017 India
Bangalore
KARNATAKA 		 8667373166

prem.v@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cranio cervical Flexor Training exercises  Feedback from a pressure biofeedback unit placed suboccipitally Patient was instructed to perform the neck nodding movement, like saying ‘YES’ The baseline pressure was set according to the activation score and performance index. Once the performance index reaches 2×10 Performed at 5 different pressure levels (22, 24, 26, 28, and 30 mmHg) and to hold each level for 10 seconds. A 10-second rest period was provided between each level. Exercise was repeated for 10 times at each level. Exercise was implemented 3 times per week for 4 weeks.  
Intervention  Proprioceptive Neuromuscular Facilitation  Techniques of PNF used Rhythmic initiation Combination of isotonics Dynamic reversals Contract relax Each pattern was performed 10 times in a day Each exercise was implemented 3 times per week for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with chronic mechanical neck pain with a duration of more than 3 months
Neck disability index scoring of ≥5%.
Numeric pain rating scale ≥ 3
 
 
ExclusionCriteria 
Details  Injury, tumor, infection, or other non mechanical cause of neck pain
Clinically significant herniated disk with positive radicular arm pain, spinal fractures, and recent cervical surgery (cervical radiculopathy, myelopathy)
A history of trauma for neck pain
A headache associated with migrane
Psychiatric illness 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale  Baseline
At the end of 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
Neck Disability Index  Baseline
At the end of 4th week 
Cervical Range of Motion  Baseline
At the end of 4th week 
 
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)   10/03/2019 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a clinical trial to find the effect of proprioceptive neuromuscular facilitation for the individuals suffering with neck pain for more than 3 months.To scale the effectiveness of proprioceptive neuromuscular facilitation on the neck muscles, we compare its effects with that of the craniocervical flexor training for such patients which has been well proved so far. Our intervention is done for three times a week for four weeks for both the groups. 
Close