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CTRI Number  CTRI/2020/12/030040 [Registered on: 24/12/2020] Trial Registered Prospectively
Last Modified On: 13/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparing the effectiveness of two different exercise training i.e. training neck muscle with extra load and training neck muscle without extra load, in individuals with neck pain.  
Scientific Title of Study   Effectiveness of Dynamic Neck Strength and Dynamic neck endurance training in reducing neck pain and improving function among patients with mechanical neck pain -A Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MUKTI CHAND MURAU 
Designation  PG student 
Affiliation  Laxmi Memorial College of Physiotherapy 
Address  1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  8792149397  
Fax    
Email  memuktimourya2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priya S 
Designation  Associate Professor 
Affiliation  Laxmi Memorial College of Physiotherapy 
Address  1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9449729147  
Fax    
Email  priya.sv1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MUKTI CHAND MURAU 
Designation  PG student 
Affiliation  Laxmi Memorial College of Physiotherapy 
Address  AJ1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
1st floor, Department of Physiotherapy, AJ towers Balmatta Mangalore
Dakshina Kannada
KARNATAKA
575002
India 
Phone  8792149397  
Fax    
Email  memuktimourya2@gmail.com  
 
Source of Monetary or Material Support  
Laxmi Memorial College of Physiotherapy, Mangalore 
 
Primary Sponsor  
Name  Laxmi Memorial College of Physiotherapy 
Address  AJ Towers, Balmatta, Mangalore, 575002 
Type of Sponsor  Other [Private Physiotherapy College] 
 
Details of Secondary Sponsor  
Name  Address 
MUKTI CHAND MURAU  AJ Towers, Balmatta, Mangalore 575002 
SANJAY EAPEN SAMUEL  AJ Towers, Balmatta, Mangalore 575002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya S  AJ Institute of Medical Sciences  Department of Physiotherapy, NH66, Kuntikana, Mangalore,575004
Dakshina Kannada
KARNATAKA 
9449729147

priya.sv1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, A J Institute of Medical Sciences & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M542||Cervicalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dynamic Neck Endurance Training  Patiets in Endurance training group will perform dynamic endurance training which includes cranio-cervical flexion exercise for deep neck flexor, lifting head backwards in prone on elbow in two ways i.e. head extension for sub-occipital muscles and lower cervical extension for long neck extensor. Each exercise will be done for 3 sets with 15-20 repetition in each set with no extra weight other than weight of the head. 
Intervention  Dynamic Neck Strength training  Patients in Strength training group will perform dynamic strength training which includes lifting head up with chin tucked in from supine position for deep neck flexors, lifting head backward in prone on elbow in two ways i.e head extension for sub-occipital muscles and lower cervical extension for long neck extensors. Each exercise will be done with half kilogram weight cuff attached around forehead for 3 sets with 8-10 repetition in each set. Fatigue will be taken into consideration to plan the number of repetitions. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patient with subacute and chronic stage neck pain
Asymmetrical neck pain worsens as day progresses
Cervical spondylosis
Medically stable 
 
ExclusionCriteria 
Details  Neck pain with NPRS less than 4 or NDI less than 20%
Acute pain and inflammation
Torticollis
Symptomatic herniated disc or severe disorders of cervical spine
Unstable or Acute Osteoarthritis
Recent fractures
Vertigo
Vertebro-basilar Insufficiency
Stroke patient
Pregnency 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale (NPRS)
% of Neck Disability Index (NDI) 
Baseline and after 2 weeks of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Numeric Pain Rating Scale (NPRS)
% of NDI 
1 Week after commencement of treatment 
 
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)   20/01/2021 
Date of Study Completion (India) 15/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/04/2021 
Estimated Duration of Trial   Years="0"
Months="3"
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)?  

Response - NO
Brief Summary  

Need of Study 

Neck pain is a common health problem that is associated with significant level of disability. It has been associated with decreased health related quality of life (HRQ0L) in several studies. Change in workplace environment with reliance on technologies for work and predominantly sedentary life style could be possible factors of the high prevalence of neck pain. Chronic mechanical neck pain represents the vast majority of cases contributing to substantial health care costs, work absenteeism, and loss of productivity at all levels of employment. In order to decrease this social burden of disability, the use of interventions with demonstrated efficacy for specific outcomes is clearly essential. There are numerous treatment options in literature for conservatively managing chronic neck pain that varies from passive rest, electro-therapeutic modalities like therapeutic ultrasound, passive techniques to active exercises. Exercise is recommended as an effective way of managing neck pain disorders and has been shown to be more effective in comparison to more passive interventions. There is also evidence that both strengthening and endurance regimens have superior benefits over other form of activities, such as stretching or massage techniques. Dynamic exercises are superior than isometric exercise as it involves movement of the joints, resulting in capsular, ligamentous and muscular flexibility and increased cartilage nutrition. Muscle strengthening occurs in all joint ranges achieved during the exercise and results in functionally more efficient muscle-joint complex. Several  researchers have found beneficial effect of dynamic strengthening exercises of neck muscles to reduce neck pain and improve neck function. Similarly, researchers have also found positive effect of dynamic endurance training in individuals with mechanical neck pain. But studies regarding comparison of these exercises, for their relative effectiveness are limited.  Therefore, the need of this study is to find out whether anyone of this intervention is superior to another or both have same efficacy to reduce neck pain and improve neck function.



Research question

Is there any difference in effectiveness of dynamic strength training and dynamic endurance training in reducing neck pain and improving function in patients with mechanical neck pain?

 

Null Hypothesis

There is no significant difference in effectiveness of dynamic strength training and dynamic endurance training in reducing neck pain and improving function in patients with mechanical neck pain.

Alternative hypothesis

There is significant difference in effectiveness of dynamic strength training and dynamic endurance training in reducing neck pain and improving function in patients with mechanical neck pain.

Methodology

Patients will be recruited from an OPD of tertiary hospital. Written consent will be taken from each patient after explanation of procedure. Patient will be allocated to either dynamic neck strength or dynamic neck endurance training. Baseline neck pain and neck disability will be assessed using Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI). Patient will receive the allocated treatment for 2 weeks under direct supervision of investigator. after completion of 2 weeks of regimen NPRS and NDI will be taken as outcome. 

Statistical analysis: Paired t-test will be used to test significant difference between pre and Post NPRS and NDI within the groups. Student’s t-test will be used to test the significant difference in the NPRS and NDI between the two groups.

 
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