| CTRI Number |
CTRI/2026/03/106447 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
METHEDOLOGICAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Testing a New Device for Measuring Neck Muscle Activity in People with Neck Pain due to poor posture. |
|
Scientific Title of Study
|
Clinical Validation Study for Feasibility and Reliability of a Novel Device for sEMG and ROM measurement using the Trapezius muscle in Participants with Postural Neck Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gita Handa Thukral |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of PMR, AIIMS, New Delhi
DEPARTMENT OF PMR, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
0112659337 |
| Fax |
|
| Email |
gitahanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gita Handa Thukral |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of PMR, AIIMS, New Delhi
Department of PMR, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
0112659337 |
| Fax |
|
| Email |
gitahanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gita Handa Thukral |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of PMR, AIIMS, New Delhi
Department of PMR, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
0112659337 |
| Fax |
|
| Email |
gitahanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Center for Assistive Health Technology AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
NCAHT AIIMS NEW DELHI |
| Address |
9th Floor, National Center for Aging Building, AIIMS, Ansari Nagar, New Delhi – 110029 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Gita Handa Thukral |
All India Institute of Medical Sciences |
Department of PMR
South
DELHI |
0112659337
gitahanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults aged 18 to 45 years
No history of neuromuscular disorders in the past 6 months
No recent musculoskeletal injury affecting trapezius muscle function (within 3 months)
Ability to perform isometric contractions for EMG testing
No known peripheral neuropathies or conditions affecting EMG signal quality
Willingness to participate and provide informed consent
Pain intensity more than or equal to 3
Moderate to severe disability using NDI
No radiculopathy or structural cervical spine pathology
No prior cervical surgery or fractures
|
|
| ExclusionCriteria |
| Details |
Neck injury or disorder at the time of the study
Inflammatory joint condition/arthritis
Fibromyalgia/ Systemic illness
Pregnancy
Neurological conditions
Skin conditions or open wounds over the electrode placement area
Chronic dizziness
Inability to follow testing protocols
Acute trauma or whiplash-associated disorder (WAD)
Severe cervical disc degeneration or myelopathy
Vestibular disorders or migraines affecting neck posture
Subject with psychological or psychiatric illness
Recent participation in neck-specific rehabilitation (within 3 months)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
sEMG amplitude/ROM for trapezius muscle activity
Neck Disability Index (NDI)
QUEST
VAS
|
The outcome will be assessed at the baseline and after one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/03/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neck pain is one of the major musculoskeletal
disorders in the adult population. Its prevalence worldwide ranges from 16.7% to
75.1%. This condition has
a complex etiology, including several factors: ergonomic (strenuous physical
activity, use of force and vibration, inadequate posture, and repetitive movement),
individual (age, body mass index, genome, and musculoskeletal pain history, behavioural
(smoking and level of physical activity), and psychosocial (job satisfaction,
stress level, anxiety, and depression). Postural neck pain syndrome(PNPS) is primarily
attributed to sustained poor posture, particularly forward head posture (FHP),
which leads to biomechanical and neuromuscular alterations, thereby increasing
mechanical load on the cervical spine, resulting in overactivation of
superficial muscles such as the upper trapezius and sternocleidomastoid, and
inhibition of deep cervical flexors, disrupting normal muscle synergy and
contributing to pain. Changes in cervical alignment can lead to
altered limits of stability and balance performance, highlighting a dynamic
feedback system between cervical musculoskeletal health and lower limb postural
control mechanisms. sEMG
measures the electrical activity produced by muscle fibers during contraction
by detecting action potentials through electrodes placed non-invasively on the
skin surface above the muscle. This technique captures the spatial and temporal
summation of motor unit action potentials, providing insight into muscle
activation patterns and the development of force. Its
non-invasive nature and real-time monitoring capability make sEMG a valuable
diagnostic and evaluative tool in physiotherapy and rehabilitation for
assessing muscle function, guiding therapy, and tailoring rehabilitation
programs to individual needs. Previous
studies have demonstrated the use of sEMG in various rehabilitation contexts,
including neurorehabilitation after spinal cord injury, muscle biofeedback, and
functional assessments following joint replacement surgeries. Despite
these advances, sEMG remains underutilized clinically, and there is a need for
broader integration and education to enhance its application in routine
physiotherapy practice, indicating a gap between research findings and clinical
implementation. The study aims To
evaluate the feasibility, reliability and validity of a novel surface
electromyography (sEMG)
device in assessing trapezius muscle activity among individuals with postural
neck pain syndrome (PNPS) and normal participants. The findings of this study are expected to
establish the role of a novel device in enhancing the assessment accuracy of
s-EMG and the range of motion of joints during physiotherapy sessions by
generating scientific reports. The objectives of the study are as follows:- 1. To evaluate the feasibility of the
device in the assessment of improvement in the trapezius
muscle in participants with PNPS. 2. To assess the test-retest
reliability of a novel device for trapezius muscle activity and ROM in PNPS. 3. To determine the concurrent
validity of a novel device for trapezius muscle activity and ROM in normal
participants.
|