Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome

Sponsor

National Yang Ming University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05627986

Collaborator

(none)

100

Enrollment

20.5

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Shoulder Impingement Syndrome Chronic Pain Transcranial Magnetic Stimulation Electroencephalography Central Nervous System	Other: No intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
chronic shoulder impingement syndrome Subjects with shoulder impingement more than 6 months will be included to assess pain threshold, neurophysiological measurements of scapular muscles.	Other: No intervention No intervention
control group 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.	Other: No intervention No intervention

Arm

Intervention/Treatment

chronic shoulder impingement syndrome

Subjects with shoulder impingement more than 6 months will be included to assess pain threshold, neurophysiological measurements of scapular muscles.

Other: No intervention

No intervention

control group

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.

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

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 - Motor evoked potential [Immediately during the experiment]
Motor evoked potential (MEP) will be described with millivolt (mV).
Corticomotor excitability measures - Cortical silent period [Immediately during the experiment]
Cortical silent period (CSP) will be measured with millisecond (ms)
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 - 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 - 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 - 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).
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

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.
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 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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria (chronic impingement syndrome group):

individuals have shoulder pain localized at the anterior or lateral aspect of shoulder more than six months
are aged 20 to 65 years old
shoulder impingement syndrome, which is confirmed by having at least three of the following: (a) positive Neer's test, (b) positive Hawkins-Kennedy test, (c) positive empty can test, (d) positive resisted external rotation test, and (e) presenting painful arc during arm elevation

Inclusion Criteria (acute/subacute impingement syndrome group):

individuals have shoulder pain localized at the anterior or lateral aspect of shoulder less than six months
are aged 20 to 65 years old
shoulder impingement syndrome, which is confirmed by having at least three of the following: (a) positive Neer's test, (b) positive Hawkins-Kennedy test, (c) positive empty can test, (d) positive resisted external rotation test, and (e) presenting painful arc during arm elevation

Inclusion Criteria (health control group)

individuals without any shoulder and neck problems
sex, age, and hand dominance match to impingement group

Exclusion Criteria:

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)
neck pain
psychosis and symptom of headache or dizziness
allergy to plaster
contraindications to the use of TMS, assessed with a safety screening questionnaire