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CTRI Number  CTRI/2023/04/051765 [Registered on: 19/04/2023] Trial Registered Prospectively
Last Modified On: 18/04/2023
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   Comprehensive ocular and cervical muscle training program for individuals with non specific neck pain  
Scientific Title of Study   Effect of comprehensive ocular and cervical muscle training program on pain, disability and quality of life in individuals with non specific neck pain - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan Agrawal 
Designation  Post Graduate Student 
Affiliation  Pravara Institute of Medical Sciences loni 
Address  DR. APJ ABDUL KALAM college of physiotherapy Pravara Institute of Medical Sciences Loni.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7720996899  
Fax    
Email  muskanagrawal2018@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Borkar 
Designation  Associate professor, Department of Orthopaedics Physiotherapy  
Affiliation  Pravara Institute of Medical Sciences loni 
Address  DR. APJ ABDUL KALAM College of Physiotherapy Pravara Institute of Medical Sciences Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9168572881  
Fax    
Email  pnb2609@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Muskan Agrawal 
Designation  Post Graduate Student 
Affiliation  Pravara Institute of Medical Sciences loni 
Address  DR. APJ ABDUL KALAM College of Physiotherapy Pravara Institute of Medical Sciences Loni.

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7720996899  
Fax    
Email  muskanagrawal2018@gmail.com  
 
Source of Monetary or Material Support  
Pravara Institute of Medical Sciences, Loni, Tal- Rahata, Dist-Ahmednagar, Maharashtra 
 
Primary Sponsor  
Name  Dr. APJ Abdul Kalam College of Physiotherapy  
Address  Dr. APJ Abdul Kalam College of Physiotherapy, loni, Ahmadnagar 
Type of Sponsor  Private medical college 
 
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 
Muskan Agrawal  Pravara Rural Hospital   Department of orthopaedic physiotherapy Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA 
7720996899

muskanagrawal2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee PMT Loni   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive ocular and cervical muscle training program   Activation of cervical muscles. Oculomotor exercises. Cervical re-education exercises Postural stability Exercises Frequency: Thrice /week Duration of Exercise Session: 40 mins for each session Exercise program will be conducted for 8 weeks  
Comparator Agent  Conventional training exercises  Conventional exercises Warm up, Stretching, Isometric Strengthening exercises, Neck range of motion exercises. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details   Participants who are pre-diagnosed with non- specific neck pain
 Aged between 18 to 40 years
 Males and females
 Non-specific neck pain without any underlying pathologies
 Pain rating 3-5 on VAS scale on activity.
 Pain less than 3 months
 
 
ExclusionCriteria 
Details  Participants who are not willing to participate in study
 Any recent surgical history around neck and Shoulder region.
 Any Autoimmune disease, systemic illness, rheumatic conditions, inflammatory joint disease, tumor, and unhealed fracture and any other spine pathologies)
 Any neurological condition.
 Psychologically unstable patients
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain with Visual Analogue scale
2.Disability with Neck Disability Index
 
Baseline week 0 and post at week 8 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life with SF-12  Baseline week 0 and post at week 8 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/04/2023 
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 Yet Recruiting 
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)?  

Response - NO
Brief Summary  

Neck and back pain are the major cause of years-lived-with disability, and neck pain is accountable for a substantial load to society.[1] Neck pain is the usual musculoskeletal problem which affects the quality of life in individuals. In fact, neck pain is rated in the fourth position as the condition giving rise to the greater number of years lived with disability.[2] Up to 70% of the worldwide population experiences neck pain at least once in their entity, which 50% to 85% is expected to become recurring within 1 to 5 years after the beginning onset.[1]

Non-specific neck pain (NNP) is a symptom associated with postural or mechanical cause. It is associated with daily activity limitation, depletion of work productivity and decrease in quality of life. NNP’s prevalence increases in industrialized countries and in urban areas; it is greater in females and in middle age. It is a symptom with a clustered etiology, and studies reveal its strong correlation with depression, anxiety, headache, sedentary life, sleep disorders and smoking. Risk factors for developing NNP insert cervical trauma such as whiplash, sports injuries and stationary work.[3]

In postural control, the correct functioning of the proprioceptive neck system is especially important in order to retain the joint position sense and the movement control of the head and cervical spine intact. Taking into consideration the neck muscles have a very high density of muscle spindles, mainly in the occipital region, and that the cervical sensory afferences have strong impact on vestibular and visual systems to control postural stability, impaired neuromuscular function of the neck muscles can widely influence postural control deficits.[4] 

The studies proving that chronic pain problems are specified by change in brain structure and function.[5,6] The pathological mechanism underlying the extension of peripheral pain is thought to involve conflict between sensory-motor cortical processing networks.[7] The cortical model of long-term pain implicated the neural consequences of incongruence between sensory and visuomotor feedback, or prolonged visuosensory-motor conflict.[8] Therapeutic measures such a mirror therapy, motor imagery programming, and virtual visual feedback aim to overcome sensory-motor incongruence and alleviate chronic limb pain. Phantom limb pain was hypothesized to be due to conflict between motor intention and visual-sensory experience in the central nervous system.[9] McCabe et al. examined mirror visual feedback for the treatment of complex regional pain syndrome type 1 and reported reduced limb pain when initiated as early as eight weeks after disease onset.[10] Moseley et al. hypothesized that preceding mirror therapy with the activation of cortical networks without limb movement would reduce pain and swelling and introduced graded motor imagery to reduce chronic limb pain and disability in patients with complex regional pain syndrome type 1 and phantom limb pain[11,12]

While these therapies are effective for the treatment of chronic limb pain, they are not effective for relieving chronic neck pain. In order to change the gaze direction, the head and the neck requires coordinated work. According to the sensorimotor incongruence, the reason of the long-term neck pain is the incongruence between the sensorimotor conflict from the cortical network areas created by the gaze direction and the sensorimotor feedback. It is therefore possible to alleviate neck pain by changing the gaze direction and adjusting the sensorimotor incongruence. The gaze direction principle based on the principle of observing the neck rotation performed by another individual and try to recognize the gaze direction with reference to the neck movements has been developed to that end.[13]

During this task the subjects observe the neck rotation of another individual sitting in front and attempt to recognize the direction of gaze. In this procedure patients with chronic neck pain were encouraged to experience mental motor imagery. During the motor imagery, activations associated with the movements in the pre-motor area, supplemental motor area and primary motor area as they have been real movements are observed.[14] Observing the movement of another individual activates the mirror neuron systems located in the temporal sulcus, supramarginal gyrus and premotor cortex.[15] The analysis of the cortical blood circulation after the gaze direction recognition task indicates a significant increase of the oxygenated hemoglobin in the related cortical areas.[16]

Here we developed a gaze direction recognition (GDR) task in which the subject observed rotation of the neck made by another individual and attempted to recognize gaze direction with reference to neck motion. 

The purpose of the study will be to find the effect of comprehensive ocular and cervical muscle training program on pain, disability, and quality of life in individuals with non-specific neck pain.

 NEED FOR THE STUDY:

Literature has shown neck pain is one of the most common problems and is gradually increasing across the globe with current prevalence of 10-21%.[13]. It affects the functional status, work performance and quality of life in individuals if it persists for long period.

Neck motion plays an important role in frequent alteration of Gaze Direction and is normally achieved by coordinated eye and neck movement. The studies have shown that prolonged neck pain can be attributed to incongruence between sensory and motor feedback in neck leading to visual motor conflict in relevant cortical network areas. Thus, it is possible to overcome this sensory and motor incongruence on the alteration of visual direction which may alter the neck pain.

Along with pain and hypomobility the deficits in cervical joint position sense, eye movement control and postural stability are also often seen in patients with neck pain this is mainly due to poor neuromuscular control and abnormal cervical afferent input.[19] Hence it is imperative to design an optimal cervical sensory and motor re-education program in coordination with ocular muscle training to control this deficit. Therefore, this study aimed to find the effect of comprehensive ocular and cervical muscle training program on pain, disability, and quality of life in patients with non-specific neck pain

 RESEARCH QUESTION

Is there any effect of comprehensive ocular and cervical muscle training program on pain, disability, and quality of life in patients with non-specific neck pain?

 

AIM AND OBJECTIVES

AIM:

To find the effect of comprehensive ocular and cervical muscle training program on pain, disability, and quality of life in patients with non-specific neck pain

 

OBJECTIVES:

1.     To find the effect of comprehensive ocular and cervical muscle training program on Pain with NPRS. 

2.     To find the effect of comprehensive ocular and cervical muscle training program on Neck disability with NDI. 

3.     To find the effect of comprehensive ocular and cervical muscle training program on Quality of life with SF12. 

Hypotheses

Null Hypothesis (H0):

There will not be any significant effect of comprehensive ocular and cervical muscle training program on pain, disability and quality of life on patients with non-specific neck pain.

Alternative Hypothesis (H1):  

There will be significant effect of comprehensive ocular and cervical muscle training program on pain, disability and quality of life on patients with non-specific neck pain. 


 
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