Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome

Completed

• Conditions: Shoulder Impingement Syndrome; Chronic Pain; Electroencephalography; Transcranial Magnetic Stimulation; Central Nervous System
• Interventions: Other: No intervention

• Registration Number: NCT05627986
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-28
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Primary Completion: 2023-08-05
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	No intervention	Healthy controls without any shoulder and neck problems will be included to compare the differences in pain threshold, neurophysiological measurements of scapular muscles, scapular kinematics and muscle activation between healthy subjects and subjects with chronic or acute shoulder impingement syndrome.
chronic shoulder impingement syndrome	No intervention	Subjects with shoulder impingement more than 6 months will be included to assess pain threshold, neurophysiological measurements of scapular muscles.

Primary Outcome Measures

Name	Time	Method
Corticomotor excitability measures - Active motor threshold	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	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	Immediately during the experiment	Motor evoked potential (MEP) will be described with millivolt (mV).
Corticomotor excitability - Area of cortical mapping	Immediately during the experiment	Area of cortical mapping will be described with square millimeter (mm2)
Corticomotor excitability - Volume of cortical mapping	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	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	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	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	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	Immediately during the experiment	Cortical silent period (CSP) will be measured with millisecond (ms)
Somatosensory cortical activity - Somatosensory evoked potentials	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	Immediately during the experiment	Subjects will be asked 30 items related to shoulder functional movement. The overall score ranges from 0 (no disability) to 100 (most severe disability).
Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)	Immediately during the experiment	Subjects will be asked 20 items to rate how often over the past week they experienced symptoms associated with depression. Response options range from 0 to 3 for each item. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Electrical sensory threshold	Immediately during the experiment	Electrical sensory threshold is the minimal intensity of stimulation required to produce the first perception of sensory and will be described with millivolts (mV).
Pressure pain thresholds	Immediately during the experiment	Pressure pain threshold of bilateral upper trapezius, levator scapulae, infraspinatus, pectoralis major, biceps brachii, middle deltoid and tibialis anterior will each be averaged and will be described with kg/cm2.
Electrical pain threshold	Immediately during the experiment	Electrical pain threshold is the minimal intensity of stimulation required to produce the first perception of pain and will be described with millivolts (mV).

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan