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
|
|
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
|
|
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, etcâ€. 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. |