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CTRI Number  CTRI/2021/10/037544 [Registered on: 25/10/2021] Trial Registered Prospectively
Last Modified On: 23/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Performance of deep cervical flexors and head posture 
Scientific Title of Study   A Study To Correlate The Performance Of Deep Cervical Flexor Muscles With Head Posture In Microscope Users 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fernandes Levy Felcy 
Designation  MPT 
Affiliation  Father Muller College Of Allied Health Sciences 
Address  Father Muller College Of Allied Health Sciences, Kankanady, Dakshina Kannada, Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7406304643  
Fax    
Email  levyfernandes77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Leah Mohandas 
Designation  Assistant Professor 
Affiliation  Father Muller College Of Allied Health Sciences 
Address  Father Muller College Of Allied Health Sciences, Kankanady, Dakshina Kannada, Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9739863768  
Fax    
Email  leahdas86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Fernandes Levy Felcy 
Designation  MPT  
Affiliation  Father Muller College Of Allied Health Sciences 
Address  Father Muller College Of Allied Health Sciences, Kankanady, Dakshina Kannada, Mangaluru

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7406304643  
Fax    
Email  levyfernandes77@gmail.com  
 
Source of Monetary or Material Support  
FATHER MULLER COLLEGE OF ALLIED HEALTH SCIENCES,KANKANADY ,MANGALORE KARNATAKA -575002 
 
Primary Sponsor  
Name  Father Muller College Of Allied Health Sciences 
Address  Father Muller College Of Allied Health Sciences, kankanady, Mangaluru-575002 
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 
Fernandes Levy Felcy  Father Muller Hospital,kankanady ,mangalore  Father Muller Hospital,kankanady,Mangalore ,Karnataka.
Dakshina Kannada
KARNATAKA 
7406304643

levyfernandes77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FATHER MULLERS INSTITUTIONAL COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Unspecified soft tissue disorder related to use, overuse and pressure 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  -All gender
-Age 20-45 years
-Microscope users working for 20-24 hours in a week since a year or more 
 
ExclusionCriteria 
Details  -Any history of trauma or surgery to the upper quarter of body
-Any neurological deficits in upper extremity
-Subjects who participated in any form of specific strengthening of neck and upper extremities muscles in past 12 months
-History of spinal surgery to the thoracic or cervical spine
-Cervical abnormalities
Systemic, muscular or connective tissue disorders
History of cancer
-History of central or peripheral nervous system disorder (multiple sclerosis, cerebrovascular accident, peripheral neuropathy  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-CRANIOCERVICAL FLEXION TEST (CCFT)
-HEAD POSTURE ANGLE WITH KINOVEA SOFTWARE
-NPRS 
At baseline only 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   28/10/2021 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Posture is defined as a balance in musculoskeletal system that involves a minimal amount of stress and strain on the body. Any deviation from this normal alignment results in a system of imbalance or abnormal strain on the musculoskeletal system. Excessive stress or strain on the musculoskeletal system leads to postural abnormalities. Musculoskeletal disorders are also known as cumulative trauma disorders, overuse syndrome and repetitive stress injury or repetitive strain injury. These are caused due to excessive forced repetitive movement, awkward posture or prolonged static posture and vibrations. Work related musculoskeletal disorders become hazardous when the tissue loading exceeds its anatomical and physiological limits therefore there should be awareness and better understanding of risk factors. The International Ergonomics Association defines Ergonomics as “The scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design in order to optimize human well-being and overall system performance”. Ergonomic risk factors are most likely to cause or contribute to an MSD.

 

            A recent survey which was conducted in Europe reported a high prevalence of musculoskeletal disorders among microscope workers. These investigators found out risk factors such as the working hours using microscope, duration of work without breaks and poor workstation ergonomics which were associated with symptoms. The most prevalent problems in microscope users are eye pain, neck pain, headaches and backache. While viewing the specimen in conventional microscopes the microscopist maintains a flexed neck posture from this view point of biomechanics there is changes in the length tension relationship in the cervical muscle, fatigue and pain.

 

           According to international association for the study of pain defines neck pain “pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line and inferior by an imaginary transverse line through the tip of first thoracic spinous process and laterally by sagittal plane tangential to the lateral border of neck.

 

            Poor head posture results in neck pain. Forward head defined as the protrusion of the head in sagittal plane so that the head is placed anterior to the trunk. Forward head posture eventually leads to shortening of posterior cervical muscles and weakening of anterior cervical flexor muscles. A specific impairment consists of motor -control deficits of cervical flexor muscles, which results in reduced activation of the deep cervical flexor muscles and overactivity of the superficial flexors eventually leading to fatigue and discomfort. If the forward head posture is maintained for every long time the shortening of the posterior cervical muscles leads to increase load on the noncontractile structures as the fascia and the connective tissue and exerts the abnormal stress on the posterior cervical structure leading to myofascial pain.

 

            The cervical flexor muscle, mainly the deep neck flexors longus capitus, longus colli, rectus capitus anterior and lateralis function to stabilize the spine. However, in cervical disorders the tonic holding capacity is less in these muscles. Neck pain is considered as chronic if it lasts for more than 3 months. Chronic neck pain symptoms have a large impact on function and QOL. Many clinical tests have been done for subjects with neck pain which focuses on assessment of neuromuscular control and function such as strength and endurance of deep neck flexors and extensors. Patients with chronic neck pain may tend to develop increased cervical lordotic posture associated with a forward head posture. Patients with chronic neck pain may tend to develop increase increased cervical lordotic posture associated with forward head posture. It is suggested that forward head posture leads to increase in the compressive forces on the cervical apophyseal joints and posterior part of the vertebra and to changes in in connective tissue length and strength resulting in pain

 

            Jull et al found out that muscular performance for the deep neck flexors was reduced in group of patients who had cervical headaches. She had developed a low load craniocervical flexion test to investigate the anatomical action of deep cervical flexors, specifically of the logus colli in synergy with longus capitusPressure biofeedback unit provides feedback and direction to the patients to perform the required five incremental stages of the test these incremental changes in pressure can be used as an outcome measure, serving as a reference point during deep cervical flexor re-education and trainingThe CCFT test is a clinical test asses an individual’s ability to slowly perform and hold a precise upper cervical flexion without flexion of the mid and lower cervical spine. It is based on the anatomical interrelated action of the deep muscles to support and stabilize the cervical spine. Patients with poor activation capabilities of their deep neck flexors may use substitution strategies to achieve contraction common substitutes include recruitment of superficial flexors, sternocleidomastoid, platysma and the hyoid. The test is stopped indicating the deep cervical performance is poor.

 

             Cervical posture has been evaluated by measuring three angle using photogrammetry they are Craniovertebral angle, cervical inclination angle, inclination angle of head. The three angular measurements are angle between C7, the tragus of the ear and horizontal; the angle between the tragus of the ear, the eye and the horizontal; the angle between the inferior margin of right and left ear and the horizontal. These angles were analysed using kinovea software. An angle less than 500-530 indicate forward head posture.

 

              Since microscopists are the most vulnerable group maybe prone to postural neck pain disorders due to faulty posture maintained while viewing the microscope. Very few studies have been conducted to understand the relationship between head posture and performance of deep cervical flexor muscles. Hence this study aimed at bridging that gap. The findings of this study could be used to prevent these problems by providing ergonomic advice to the subjects.

         

OPERATIONAL DEFINITIONS:

 

Activation Score: The activation score is defined as the maximum pressure (in millimetres of mercury) achieved and held in a steady manner for 10 seconds above the baseline pressure (20 mmHg), without any substitution strategy in craniocervical flexion test (CCFT). 

Performance Index: A performance index was calculated by multiplying the target pressure achieved (activation score) by the number of successful repetitions

Neck Pain: Pain perceived as arising from anywhere within the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by sagittal plane tangential to the lateral border of neck

 

RESEARCH QUESTIONS

Is there any correlation between the head posture and performance of deep cervical flexor muscles in microscope users?

ALTERNATIVE HYPOTHESIS (H1):

There is a correlation between the head posture and performance of deep cervical flexor muscles in microscope users

NULL HYPOTHESIS (H0):

There is no correlation between the head posture and performance of deep cervical flexor muscles in microscope users.

 

 
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