Shoulder Impingement SyndromeNCT05627986
Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome
An observational study of Shoulder Impingement Syndrome and Chronic Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement Syndrome, Chronic Pain, Transcranial Magnetic Stimulation
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic impingement syndrome, acute/subacute impingement syndrome and the matched healthy control subjects.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- psychosis and symptom of headache or dizziness
- allergy to plaster
- contraindications to the use of TMS, assessed with a safety screening questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome and the Sensorimotor Excitability and Control in Acute/subacute Stage Related to Development of Chronicity
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
- Being tested
- No intervention
- Keywords
- Shoulder Impingement Syndrome, Corticospinal system, somatosensory system
- Medical subject headings
- Shoulder Impingement Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| chronic shoulder impingement syndrome | Subjects with shoulder impingement more than 6 months will be included to assess pain threshold, neurophysiological measurements of scapular muscles. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticomotor excitability measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Measured: Immediately during the experiment
Corticomotor excitability measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV).
Measured: Immediately during the experiment
Corticomotor excitability measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms)
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately during the experiment
Corticomotor excitability - Area of cortical mapping
Area of cortical mapping will be described with square millimeter (mm2)
Measured: 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
Measured: 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).
Measured: 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).
Measured: Immediately during the experiment
Somatosensory cortical activity - Somatosensory evoked potentials
Somatosensory evoked potentials (SEP) will be described with microvolt (µV) and millisecond (ms).
Measured: 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.
Measured: 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.
Measured: Immediately during the experiment
Secondary outcomes (5)
Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Subjects will be asked 30 items related to shoulder functional movement. The overall score ranges from 0 (no disability) to 100 (most severe disability).
Measured: Immediately during the experiment
Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)
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.
Measured: Immediately during the experiment
Pressure pain thresholds
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.
Measured: Immediately during the experiment
Electrical sensory threshold
Electrical sensory threshold is the minimal intensity of stimulation required to produce the first perception of sensory and will be described with millivolts (mV).
Measured: Immediately during the experiment
Electrical pain threshold
Electrical pain threshold is the minimal intensity of stimulation required to produce the first perception of pain and will be described with millivolts (mV).
Measured: Immediately during the experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start28 Aug 2022
- Primary completion5 Aug 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin-Liang Lin, National Yang Ming Chiao Tung University
- Investigators
- Yin-Liang Lin, PhD, Principal investigator, National Yang Ming Chaio Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627986
- Sponsor's protocol ID
- YM111008F
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Cortex Excitability in Shoulder Impingement Syndrome and the Sensorimotor Excitability and Control in Acute/subacute Stage Related to Development of Chronicity
- ClinicalTrials.gov ID
- NCT05627986
- Acronym / sponsor ID
- YM111008F
- Conditions
- Shoulder Impingement Syndrome, Chronic Pain, Transcranial Magnetic Stimulation, Electroencephalography, Central Nervous System
- Keywords
- Shoulder Impingement Syndrome, Corticospinal system, somatosensory system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic shoulder impingement syndrome | – | Other: No interventionSubjects with shoulder impingement more than 6 months will be included to assess pain threshold, neurophysiological measurements of scapular muscles. |
| control group | – | Other: No interventionHealthy 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic impingement syndrome, acute/subacute impingement syndrome and the matched healthy control subjects.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | chronic shoulder impingement syndrome, control group |
Primary outcome
Corticomotor excitability measures - Active motor threshold
Time frame: 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
Time frame: Immediately during the experiment
Motor evoked potential (MEP) will be described with millivolt (mV).
Corticomotor excitability measures - Cortical silent period
Time frame: Immediately during the experiment
Cortical silent period (CSP) will be measured with millisecond (ms)
Corticomotor excitability measures - Short interval cortical inhibition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately during the experiment
Area of cortical mapping will be described with square millimeter (mm2)
Corticomotor excitability - Volume of cortical mapping
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Shoulder pain and function-Taiwan version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Immediately during the experiment
Depression- Taiwan version of the Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Immediately during the experiment
Pressure pain thresholds
Time frame: Immediately during the experiment
Electrical sensory threshold
Time frame: Immediately during the experiment
Electrical pain threshold
Time frame: Immediately during the experiment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Liang Lin, PhD principal investigator
National Yang Ming Chaio Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Impingement Syndrome and Chronic Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticomotor excitability measures - Active motor threshold (time frame: Immediately during the experiment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.