REF/2012/12/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Tue, 08 May :58:26 GMT) CTRI Number Last Modified On 13/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/02/ [Registered on: 14/02/2013] - Trial Registered Prospectively Yes Observational Cross Sectional Study Other A study to find out the the maximum pressure exerted by the deep neck flexor muscles using craniocervical flexion test in healthy adult population A CROSS-SECTIONAL STUDY TO FIND OUT THE ACTIVATION SCORE OF DEEP NECK FLEXORS USING CRANIOCERVICAL FLEXION TEST IN HEALTHY ADULT POPULATION Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Principal Investigator MsPais Larita Lawrence mpt student Phone father muller medical college mangalore. father muller medical college,father muller road,kankanady, mangalore. laritapais@gmail.com Details Contact Person (Scientific Query) MrSudeep Pais assistant proffesor Phone father muller medical college mangalore. sudeep_pais@hotmail.com Details Contact Person (Public Query) Mr Sudeep Pais assistant proffessor fr. muller medical college mangalore. page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Phone sudeep_pais@hotmail.com Source of Monetary or Material Support > Father muller medical college,father muller road,kankanady,mangalore- Type of Sponsor List of Countries of Principal Investigator Primary Sponsor Details MsPais Larita Lawrence father muller medical college,father muller road,kankanady,mangalore. Other [myself] MsPais Larita Lawrence physiotherapy opd,ground floor father muller medical college, hospital of Site Site Phone// father muller road,kank anady,mangalore laritapais@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? father muller institutional ethics committee Status Health Type Healthy Human Volunteers Approved 15/11/2012 No Date No Date Specified Condition healthy normal adults Type Details Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria (1)Age :21-40 years healthy adult population Exclusion Criteria (1) Pain on palpation of cervical joints (2) Neck or thoracic region pain within the last year. (3) Headaches within the last year that resulted in limitation of daily activities. (4) History of spinal surgery to the thoracic or cervical spine. (5)Temporomandibular joint (TMJ) dysfunction. (6)Subjects who have undergone dental work in the previous 12 months,or have. dental braces page 2 / 5

3 Concealment Blinding/Masking Primary Outcome Outcome Timepoints CCFT activation score outcome will be measured at the level the subject is unable to go to the next level Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary influence of CCFT activation score on the gender and age Total Sample Size=200 Sample Size from =200 N/A 01/06/2013 No Date Specified Years=0 Months=6 Days=0 Not Yet Recruiting outcome will be assessed at the end of the study during data analysis The cervical flexors, mainly the deep neck flexors (DNF) longus capitis, longus colli, rectus capitis anterior and lateralis, are said to be responsible in the cervical spine stabilization during neck movements.however, in case of cervical disorders their tonic holding capacity can be less. Patients with a history of neck pain, on use of the arm, often show a delay in neck muscle activity indicating a significant deficit in the automatic feed forward control of the cervical spine and as the deep cervical muscles are important for the stability of the cervical lordosis and the cervical joints, any change in the feed forward response may leave the cervical spine vulnerable to reactive forces from arm movement. The craniocervical flexion test (CCFT) is a clinical test of the anatomical action of the DNF muscles and has evolved over 15 years as both a clinical and research tool and was devised in response to research indicating the importance of the deep cervical flexors in support of the cervical lordosis and motion segments and clinical observations of their impairment with neck pain. The clinical tests of the DNF previously involved the performance of a maximum voluntary contraction. Tests where DNF muscles were engaged during a head lift against gravity have also been used.these are said to be high load tests that do not give a clear idea of differences between activation of deep and superficial cervical flexors and do not reflect the deep muscles functional requirements in sustaining low-intensity contractions to support the cervical joints in many functional activities including prolonged postures and repetitive movements. page 3 / 5

4 The craniocervical flexion test (CCFT) is a low-load test to target the DNF muscles, longus capitus and longus colli and has been designed to assess their tonic holding capacity. It is based on anatomical grounds that craniocervical flexion or a head nodding movement is the action of longus capitus and colli and not the action of other superficial neck flexors such as sternocleidomastoid and, the scalenes and on the hypothesis of an altered neuro-motor strategy in the neck flexor synergy with neck pain The role of DNF muscles in normal and abnormal neck function has evolved over the years and is significantly appreciated, since there is association between DNF muscle torque and endurance deficits and patient complaints of head and neck pain,therefore protocol which is reliable and appropriate and for testing of DNF muscle, will be of great value to the clinician in prevention and management of neck pain. Measurement of the muscle performance in the CCFT in the clinical setting is essential since the muscles are deeply situated and any contraction in these muscles cannot be seen, and manual resistance, which can be used to grade a contraction, is not desirable as it would recruit required synergists to resist the force. CCFT is one of precision and control and is regarded as the most effective means of assessing and retraining the contractile performance of these muscles.the test consist five incremental stages of craniocervical range of motion (ROM), guided by feedback from a Pressure Biofeedback Unit (PBU; Stabilizer, Chattanooga Group, Australia).These incremental changes in pressure can be used as an outcome measure, serving as a reference point during DNF re-education and training.studies have shown that the CCFT activates the intended muscles, establishing its construct validity.in addition, the CCFT also demonstrates excellent intra-rater reliability. However, the data regarding the normal values of CCFT is limited, with variations from ideal neuromotor control frequently reported in the asymptomatic population. Hence, the diagnostic application of the CCFT is somewhat inadequate, highlighting the need for high quality normative studies. Also the previous studies have limitations with regards to their small sample size which might have had an impact on the results. Hence a study on a larger scale is necessary for better research. The clinical guidelines for neck pain include the CCFT as an important component in cervical spine examination.according to the International Classification of Functioning, Disability, and Health, this test can be used when page 4 / 5

5 Powered by TCPDF ( REF/2012/12/ classifying a patient in the impairment-based category for neck pain with headaches and for neck pain with movement coordination impairments. Thus, there is a need to find out a normal value for the CCFT and also to check for the differences in DNF muscle activity that can be influenced by the person s age and gender.this would indeed benefit clinicians and their clients with a baseline for establishing and monitoring programs designed to increase cervical flexor endurance. RESEARCH QUESTIONS: What is the mean craniocervical flexion test activation score in healthy adult population? Is there a influence of age and gender on the craniocervical flexion test activation score? HYPOTHESIS(H 1): There is an influence of age and gender on the craniocervical flexion test activation score. NULL HYPOTHESIS(H 0): There is no influence of age and gender on the craniocervical flexion test activation score. page 5 / 5