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CTRI Number  CTRI/2025/02/080615 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   COMPARISON OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION WITH SEMISPINALIS CERVICIS TRAINING ON PAIN AND DISABILITY IN NECK PAIN  
Scientific Title of Study   EFFECT OF PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION VERSUS SEMISPINALIS CERVICIS TRAINING ON PAIN AND FUNCTIONAL DISABILITY IN CHRONIC 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  Jyoti Ojha 
Designation  Post graduate student(MPT) 
Affiliation  School of Health Sciences 
Address  Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar UTTAR PRADESH 208024 India

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9630418576  
Fax    
Email  jyotibjri1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandra Shekhar Kumar PT 
Designation  Assistant Professor 
Affiliation  School of Health Sciences 
Address  Room no 128 ,Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar UTTAR PRADESH 208024 UTTAR PRADESH 208024 India
Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9919630553  
Fax    
Email  chandrasekhar@csjmu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chandra Shekhar Kumar PT 
Designation  Assistant Professor 
Affiliation  School of Health Sciences 
Address  Room no 128 ,Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar UTTAR PRADESH 208024 UTTAR PRADESH 208024 India
Department Of Physiotherapy ,School Of Health Sciences ,Chhatrapati Shahuji Maharaj University ,kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9919630553  
Fax    
Email  chandrasekhar@csjmu.ac.in  
 
Source of Monetary or Material Support  
Department of physiotherapy, School of health sciences, Chhatrapati Shahu ji Maharaj University, kanpur, Uttar pradesh India Pin code 208024 
 
Primary Sponsor  
Name  School of Health Sciences 
Address  Room no SHS 106, Department Of Physiotherapy, School of Health Sciences, Chhatrapati Shahuji Maharaj University, Kanpur UTTAR PRADESH 208024 India 
Type of Sponsor  Research institution 
 
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 Chandrashekhar Kumar  School of health sciences, Kanpur Nagar   Room no SHS 128, Department Of Physiotherapy, Chhatrapati Shahuji Maharaj University, Kanpur Nagar UTTAR PRADESH 208024 India
Kanpur Nagar
UTTAR PRADESH 
9919630553

chandrasekhar@csjmu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethical Committee, Chhatrapati shahuji Maharaj University, kanpur  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  Proprioceptive Neuromuscular Facilitation  the movement is performed by the patient with the help of therapist on the neck pattern (a)Cranio-cervical extension with left rotation (b)Cranio-cervical flexion with right rotation (c)Cranio-cervical flexion with left rotation (d)Cranio-cervical extension with a right rotation. Thrice a week for four weeks. 
Comparator Agent  Semispinalis Cervicis Training  The therapist placed the thumb and index finger on the posterior vertebral arch of C2 and pushed gently into flexion while the opposite hand stabilized the patient shoulder. Patient was asked to resist maximum voluntary contraction in the direction of extension without provocation of neck pain. Thrice a week for four weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Neck pain with a duration of at least 3
months or more.
NDI Scoring greater and equal to 5%
NPRS scoring of greater and equal to 3
 
 
ExclusionCriteria 
Details  Cervical Radiculopathy or Myelopathy
Spinal infection
Cervical or Thoracic spine Fracture /
Dislocation
Surgery of the cervical or thoracic spine
Psychic illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
NPRS
NDI
Both Outcomes are used to Determine the effect of intervention.  
At baseline,4 Week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   24/02/2025 
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="2"
Months="0"
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 - NO
Brief Summary  

Background

Neck Pain is the 4th highest Musculoskeletal Condition in the General Population. The Prevalence of neck pain is 352 per 100,000 population and the incidence rate is 806.6. It Is Generally Higher in Females and Middle Age Group people. About two-thirds of people experience neck pain in middle age because of prolonged use of mobile and computer devices, without any physical activity. It is primarily caused by postural or mechanical basis.

Need of study

Previous studies have shown significant effect of PNF and Semispinalis cervicis training on mechanical neck pain. However, to the best of my knowledge there is no study available which shows that among these intervention which one provides better outcome. Therefore our need of the study is to identify the effect of PNF and semispinalis cervicis training on pain tolerance and functional disability in mechanical neck pain.

Aim of study

The aim of the study is to Compare the effect of PNF versus semispinalis cervicis training on pain and function in mechanical neck pain.

METHODOLOGY

In this study, Mechanical Neck Pain patients will be screened first and those fulfilling the inclusion criteria of our study will be selected. The written consent will be signed from the patient to ensure that they are willingly participating in the study. The consent shall be taken before commencement of the study. The participants will be explained about the study procedures. The patients will be randomly divided into two groups (A and B) of equal participants i.e. 25 Patients in each group using block randomization method. Then, the baseline assessments of pain and functional disability will be done.

.

Protocol for Proprioceptive Neuromuscular Facilitation:

The patient was in sitting position and the therapist stands behind the patient. The movement is performed by the patient with the help of therapist on the neck pattern 

(a) Cranio-cervical extension with left rotation, (b) Cranio-cervical flexion with right rotation, (c) Cranio-cervical flexion with left rotation, (d) Cranio-cervical extension with a right rotation, these movements are combination of isotonic, dynamic reversal, and contract relaxation. Each pattern is performed for 10 repetitions with 10 min. Hold each stretch for 30 seconds, a 10-second push phase followed by 10-second relaxation phases. The treatment was given thrice a week for four weeks.

Protocol for Semispinalis Cervicis training:

The patients sitting on a stool without a backrest with a hip knee flexed 90 degrees and feet placed on the floor and the therapist stands on the side of the patient. The therapist placed the thumb and index finger on the posterior vertebral arch of C2.and pushed gently into flexion while the opposite hand stabilized the patient shoulder. Patient was asked to resist maximum voluntary contraction in the direction of extension without provocation of neck pain. The exercise was performed 10 minutes per set with 3 sets per day, hold resistance 10 sec, and 30 sec rest was allowed. Treatment to be performed for 10 min. The treatment was given thrice a week for four weeks.

 

 

 

 

 

 

 
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