跳至主要内容
临床试验/CTRI/2026/03/106447
CTRI/2026/03/106447尚未招募不适用

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

NCAHT AIIMS NEW DELHI1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
sEMG amplitude/ROM for trapezius muscle activity

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

  • •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).

结局指标

主要结局

sEMG amplitude/ROM for trapezius muscle activity

时间窗: The outcome will be assessed at the baseline and after one week

Neck Disability Index (NDI)

时间窗: The outcome will be assessed at the baseline and after one week

QUEST

时间窗: The outcome will be assessed at the baseline and after one week

VAS

时间窗: The outcome will be assessed at the baseline and after one week

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
NCAHT AIIMS NEW DELHI
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Gita Handa Thukral

AIIMS New Delhi

研究点 (1)

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