Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome

NCT05627986 | Completed

• 1 other identifier: YM111008F
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Impingement Syndrome; Chronic Pain; Transcranial Magnetic Stimulation; Electroencephalography; Central Nervous System

Keywords

Shoulder Impingement Syndrome; Corticospinal system; somatosensory system

Outcome Measures

Primary Outcomes (13)

• Corticomotor excitability measures - Active motor threshold

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

  Immediately during the experiment

• Corticomotor excitability measures - Motor evoked potential

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

  Immediately during the experiment

• Corticomotor excitability measures - Cortical silent period

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

  Immediately during the experiment

• Corticomotor excitability measures - Short interval cortical inhibition

  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

  Immediately during the experiment

• Corticomotor excitability measures - Short interval cortical facilitation

  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

  Immediately during the experiment

• Corticomotor excitability measures - Long-interval intracortical inhibition

  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

  Immediately during the experiment

• Corticomotor excitability - Area of cortical mapping

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

  Immediately during the experiment

• Corticomotor excitability - Volume of cortical mapping

  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

  Immediately during the experiment

• Corticomotor excitability - Center of gravity of cortical mapping

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

  Immediately during the experiment

• Resting brain activity - resting EEG with eye open/closed

  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).

  Immediately during the experiment

• Somatosensory cortical activity - Somatosensory evoked potentials

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

  Immediately during the experiment

• Event-related synchronization or desynchronization - Movement evoked pain potentials

  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.

  Immediately during the experiment

• Muscle activation during arm elevation

  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.

  Immediately during the experiment

Secondary Outcomes (5)

• 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

• Pressure pain thresholds

  Immediately during the experiment

• Electrical sensory threshold

  Immediately during the experiment

• Electrical pain threshold

  Immediately during the experiment

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention

chronic shoulder impingement syndrome; control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic impingement syndrome, acute/subacute impingement syndrome and the matched healthy control subjects.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Chronic Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yin-Liang Lin, PhD

  National Yang Ming Chaio Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: August 28, 2022
• Primary Completion: August 5, 2023
• Study Completion: April 30, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

TW (1)