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临床试验/NCT05627986
NCT05627986已完成不适用

Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome and the Sensorimotor Excitability and Control in Acute/subacute Stage Related to Development of Chronicity

National Yang Ming Chiao Tung University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Corticomotor excitability measures - Active motor threshold

研究概览

简要总结

Shoulder pain is a common musculoskeletal system complaint, accounting for 7-34% of patients in the clinic. The most common shoulder problem is subacromial impingement syndrome (SIS). Up to 45% of individuals with SIS may have unsuccessful treatment and still complain of symptoms after 2 years. This chronicity of pain may not be fully explained by structural injuries or damage, but may be related to sensorimotor changes. Decreased corticospinal excitability and increase inhibition have been found in individuals with SIS. These central motor changes may link to alteration in pain and nociception processing and the somatosensory system, which has been found in individuals with low back pain. Hyperalgesia has been found over both affected and unaffected shoulders in patients with SIS, indicating central and peripheral sensitization. However, no study has investigated whether there are changes in the central somatosensory system. Therefore, the objectives of this proposal are (1) to investigate the corticomotor and somatosensory system in patients with SIS (2) to investigate the relationship between the corticomotor and somatosensory alterations in patients with SIS. Subjects with chronic SIS and healthy subjects were recruited, with 32 people in each group. Electroencephalography (EEG) will be used to collect somatosensory activity, including somatosensory evoked potentials, spectral analysis of EEG oscillations and event-related spectral perturbation (ERSP) of the shoulder movement. Electromyography will be used to record muscle activity. Transcranial magnetic stimulation will be used to test corticomotor excitability, including active motor threshold, motor evoked potentials, cortical silent period, and intracortical inhibition and facilitation. The pressure pain threshold will be collected by a pressure algometer on the muscles of bilateral arms and legs. Pain intensity will be assessed with the Numeric Rating Scale. Shoulder function will be evaluated with the Disability of Arm, Shoulder and Hand questionnaire. Depression will be evaluated with Center for Epidemiologic Studies Depression Scale (CES-D).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • have a history of dislocation, fracture, adhesive capsulities, or surgery of upper extremity
  • arm elevation angle less than 150 degrees
  • a history of direct contact injury to the neck or upper extremities within the past 12 months
  • brain injury and neurological impairment
  • inflammatory cause of the pain (e.g., rheumatoid arthritis)
  • psychosis and symptom of headache or dizziness
  • allergy to plaster
  • contraindications to the use of TMS, assessed with a safety screening questionnaire

结局指标

主要结局

Corticomotor excitability measures - Active motor threshold

时间窗: Immediately during the experiment

Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).

Corticomotor excitability measures - Short interval cortical inhibition

时间窗: Immediately during the experiment

Short interval cortical inhibition (SICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms

Corticomotor excitability measures - Motor evoked potential

时间窗: Immediately during the experiment

Motor evoked potential (MEP) will be described with millivolt (mV).

Corticomotor excitability - Area of cortical mapping

时间窗: Immediately during the experiment

Area of cortical mapping will be described with square millimeter (mm2)

Corticomotor excitability - Volume of cortical mapping

时间窗: Immediately during the experiment

Volume of cortical mapping will be calculated with multiplying summation of motor evoke potentials on the map (mV) by the area of the map (mm2) with the unit of mV\*mm2

Corticomotor excitability measures - Short interval cortical facilitation

时间窗: Immediately during the experiment

Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms

Corticomotor excitability measures - Long-interval intracortical inhibition

时间窗: Immediately during the experiment

Long-interval intracortical inhibition (LICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms

Corticomotor excitability - Center of gravity of cortical mapping

时间窗: Immediately during the experiment

Center of gravity of cortical mapping will be described in a x-y coordinate system (mm).

Resting brain activity - resting EEG with eye open/closed

时间窗: Immediately during the experiment

EEG signals will be processed with power spectrum density analysis to calculate frequency power at Theta (3-8 Hz), alpha (8-13 Hz), beta (13-30 Hz) bands, and Gamma (30 Hz above).

Corticomotor excitability measures - Cortical silent period

时间窗: Immediately during the experiment

Cortical silent period (CSP) will be measured with millisecond (ms)

Somatosensory cortical activity - Somatosensory evoked potentials

时间窗: Immediately during the experiment

Somatosensory evoked potentials (SEP) will be described with microvolt (µV) and millisecond (ms).

Event-related synchronization or desynchronization - Movement evoked pain potentials

时间窗: Immediately during the experiment

Movement evoked pain potentials will be processed with power spectrum density analysis to calculate frequency power at Theta (3-8 Hz), alpha (8-13 Hz), beta (13-30 Hz) bands, and Gamma (30 Hz above) while raising hand.

Muscle activation during arm elevation

时间窗: Immediately during the experiment

The root mean square of electromyography (EMG) data of the anterior deltoid and infraspinatus will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated in two segments, including arm elevating and arm lowering.

次要结局

  • Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Immediately during the experiment)
  • Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)(Immediately during the experiment)
  • Electrical sensory threshold(Immediately during the experiment)
  • Pressure pain thresholds(Immediately during the experiment)
  • Electrical pain threshold(Immediately during the experiment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yin-Liang Lin

Assistant Professor

National Yang Ming Chiao Tung University

研究点 (1)

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