FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044222 [Registered on: 21/07/2022] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessing pose and balance problems in patients with neck pain 
Scientific Title of Study   Analysis of Posture and Balance impairment using Biodex Balance SD in subjects with Chronic Non-Specific Neck Pain -An Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nithin Prakash 
Designation  Ph.D. Scholar 
Affiliation  Manipal Hospital Bangalore 
Address  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore India Bangalore KARNATAKA Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  9915803047  
Fax    
Email  nithinprakash8891@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal Hospital Bangalore 
Address  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore India Bangalore KARNATAKA Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Karvannan H 
Designation  Associate Professor 
Affiliation  Manipal Hospital Bangalore 
Address  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore India Bangalore KARNATAKA Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Source of Monetary or Material Support  
No.98, Rustam Bhag Road, Old Airport Road,Department of Physiotherapy, Maniapl College of Health Professions, Manipal Academy of Higher Education, Bangalore 560017 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104 
Type of Sponsor  Research institution and hospital 
 
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 
NITHIN PRAKASH  Manipal Hospitals Bangalore  Department of Physiotherapy,Out Patient Service, Upper basement, , Manipal Hospital #98, HAL,Old Airport Road, Bangalore India Bangalore KARNATAKA
Bangalore
KARNATAKA 
9915803047

nithinprakash8891@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committe of Manipal Hospitals, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal individuals without any musculoskeletal pain 
Patients  (1) ICD-10 Condition: M990||Segmental and somatic dysfunction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Inclusion criteria for neck pain
1.Pain isolated to neck/cervical region
2.Non-specific neck pain for more than 6 months

Inclusion criteria for Healthy individuals
1.Individuals with absence of musculoskeletal pain in 6 months
 
 
ExclusionCriteria 
Details  1.Patients with serious neck pathologies (cervical myelopathy, neoplastic conditions, upper cervical ligamentous instability, vertebral artery insufficiency, inflammatory or systemic diseases)
2.Patients with history of Cervicogenic headache
3.Patients with Radiculopathy symptoms
4.Any recent Trauma to upper extremity or neck including History of Whiplash Injury
5.Previous surgery to neck or shoulder
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Balance System TM SD- Biodex Medical Systems  Baseline assessment (0 weeks- at time of enrollment) 
 
Secondary Outcome  
Outcome  TimePoints 
Pain
Disability 
Baseline assessment 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2022 
Date of Study Completion (India) 01/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Prakash N, Cleland J, Kalyan HK, Roy AK, Jose NM, Harikesavan K. Analysis of posture and balance impairments in individuals with chronic nonspecific neck pain—an observational study. Health Science Reports. 2024 Jul;7(7):e2215. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Neck pain is a common prevailing musculoskeletal disorder affecting various age groups. Neck pain is listed as one among the most burdensome chronic musculoskeletal problem globally.Though many etiological factors exist for neck pain, but the etiology is often illusive. The presentation of neck pain is usually non-specific or mechanical neck pain. Non-specific neck pain  is defined “as pain in the posterior and lateral aspect of the neck between the superior nuchal line and the spinous process of the first thoracic vertebra with no signs or symptoms of major structural pathology and no or minor to major interference with activities of daily life as well as with the absence of neurological signs and specific pathologies; such as: traumatic sprain and fracture, tumour, infectious or inflammatory cervical spondylolysis, etc”.

Chronic non-specific neck pain is associated with disability, deficits in muscular strength and range of motion, increased pain sensitivity and impaired proprioception. Proprioception is an interoceptive sense that provides informative inputs to central nervous system for motor planning. Cervical spine plays a major role in balance and proprioception as the information from cervical spine has direct access to the center for balance and proprioception. Patients with neck pain  experience  somatosensory deficits due to multiple causes including  sensitivity of receptors , alteration of cortical representation and modulation of cervical afferent inputs.Also, muscles of cervical region mainly suboccipital and deep flexor muscles have high density of muscle spindle that contribute to neck proprioception and impairment in information from these muscles affect postural sway.

Studies have shown that neck pain associated with whiplash injuries and idiopathic neck pain have impact on balance and proprioception. Also, a systematic review on standing balance in patients with idiopathic neck pain and whiplash injuries has stated that they present with poorer balance than the normal population. Whiplash induced trauma damages the key systems of postural control mainly the vestibular and neck receptors for the central nervous system, causing impairments in postural control. On contrary to whiplash injuries there is no inciting trauma in idiopathic neck pain, where the suggested mechanism is likely to be the impaired peripheral mechanoceptors, but a much more precise mechanism to be attributed for this can be proprioceptive dysfunction from spinal and supraspinal causes.Though studies have been done on the assessment of balance and proprioception in patients with neck pain, there is a lack of evidence on the usage of objective assessment to quantify the level of impairment in balance and postural sway.

Biodex Balance SD is an instrument used to quantify the balance and postural sway in individuals with a high reliability of 0.94 for Overall Stability Index.  It is an instrument equipped with circular platform with which measures both static and dynamic balance.  The platform is capable of moving in all 4 directions and adopting 12 static positions and the ability to move in 20 degrees in each direction makes it capable of measuring Antero-Posterior Stability Index and Medio-Lateral Stability Index. Measurement of these indices will quantify the balance and postural sway which will provide a better insight to the dynamic and static balance issues in patients with neck pain.

Existing literature suggests that, there exists a scarcity in the objective assessment of balance and postural sway done in patients with non-specific neck pain. Studies were done on postural and balance impairment with force different objective measures, but a system dedicated to balance assessment has not been used in the previous studies. Hence, this study aims at analyzing the standing balance and postural sway in patients with non-specific neck pain using Biodex Balance SD.

 
Close