Shoulder Impingement SyndromeNCT04014491
The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome
A study testing scapular strengthening exercise in people with Shoulder Impingement Syndrome and Transcranial Magnetic Stimulation, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Shoulder impingement syndrome is the most common shoulder disorder in overhead athletes. It describes a mechanical compression of subacromial bursa and rotator cuff tendons during arm movement, which results in pain and injuries. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement Syndrome, Transcranial Magnetic Stimulation, Central Nervous System
- What is being tested?
- scapular strengthening exercise
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2019to 28 Feb 2021
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Practice overhead exercise more than six hours a week,
- Aged 20 to 40 years old,
- Have shoulder pain localized at the anterior or lateral aspect of shoulder more than two weeks,
- Have obvious medial border prominence of the scapula at 90° of arm elevation,
- Have shoulder impingement syndrome, which is confirmed by having at least two of the following: (a) positive Neer test, (b) positive Hawkins sign, (c) positive empty can test, (d) positive resisted external rotation test, and (e) tenderness of the rotator cuff tendons
- Practice overhead exercise more than six hours a week,
Show all 15Show fewer
- Aged 20 to 40 years old,
- Not have a history of shoulder or neck pain or injury.
- Exclusion Criteria (patients of shoulder impingement and healthy subjects)
- Have a history of dislocation, fracture, or surgery of upper extremity,
- A history of direct contact injury to the neck or upper extremities within the past 12 months,
- A concussion within the past 12 months or a history of three or more concussions,
- Brain injury and neurological impairment,
- History of frequent headache or dizziness,
- Contraindications to the use of TMS, assessed with a safety screening questionnaire, including pregnancy, history of seizure, epilepsy and syncope, having cochlear implant, having medal implant and taking anti-depressant medication.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Scapular Control and Strengthening Training on Neuromuscular Control and Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome
Shoulder impingement syndrome is the most common shoulder disorder in overhead athletes. It describes a mechanical compression of subacromial bursa and rotator cuff tendons during arm movement, which results in pain and injuries. Most of previous studies focus on investigating motor performance in individuals with shoulder impingement syndrome and found altered scapular kinematics and muscle activation may contribute to the impingement. Recently few studies found changes in the central nervous system, decreases in corticospinal excitability and increases in inhibition in scapular muscles, by using transcranial magnetic stimulation (TMS). Although more studies are still needed to investigate the changes in central nervous system in the individuals with impingement syndrome, the changes in central nervous system are believed to be associated with the deficits of impingement syndrome. However, the exercise protocols for the impingement syndrome are usually designed to restore scapular kinematics and muscle activation, including scapular muscle strengthening exercise and scapular control exercise. To our knowledge, no study has investigated whether these exercise protocols can reverse these changes in the corticospinal system. The objectives of this proposal are to understand neuromuscular and neurophysiological mechanisms of the scapula-focused exercise protocols to improve the effectiveness of treatment. The study aims to investigate the effects of scapular muscle strengthening training and scapular control training on the scapular kinematics, muscle activation and corticospinal system. The study also aims to investigate whether any other cortical mechanisms are also affected by the shoulder impingement syndrome. We will recruit 70 overhead athletes with shoulder impingement syndrome and 22 healthy control athletes. Subjects with shoulder impingement syndrome will randomly receive either scapular muscle strengthening or scapular control training. When performing the exercise, subjects in the scapular control training group will receive electromyography feedback and cues but those in the strengthening training group will not. Immediate effects of these two training protocols on scapular kinematics, muscle activation, and neurophysiological measures will be tested before and after the training. Neurophysiological measures will be tested by TMS, including corticospinal excitability, cortical inhibition, intracortical inhibition, and intracortical facilitation.
- Conditions
- Shoulder Impingement Syndrome, Transcranial Magnetic Stimulation, Central Nervous System, Biomechanical Phenomena
- Being tested
- Scapula control exercise, scapular strengthening exercise, No intervention
- Keywords
- Shoulder impingement syndrome, Transcranial magnetic stimulation, Corticospinal system, Scapular control exercise, Kinematics
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapula control exerciseProcedure or surgery
To perform arm elevation in the scapular plane, subjects will be first asked to correct scapular resting posture in sitting with EMG biofeedback. Then the subjects will be instructed to do elevation in the scapular plane, side lying external rotation and dynamic hug plus with control of the scapula by EMG feedback and verbal cues
scapular strengthening exerciseProcedure or surgery
The subjects in the scapular strengthening group will be asked to perform these three exercises the same as scapula control group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Scapula control exercise | Experimental | Subjects will perform three exercises with EMG biofeedback and verbal cues. Three exercises are elevation in scapular plane, sidelying external rotation and dynamic hug plus Receives: Procedure: Scapula control exercise |
| Scapula strengthening exercise | Experimental | The subjects in the scapular strengthening group will be asked to perform the three exercises the same as scapula control exercise group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction. Receives: Procedure: scapular strengthening exercise |
| Healthy subject group | Other | Healthy subjects will be included to compare the differences in corticospinal system between healthy subjects and subjects with shoulder impingement syndrome, so this group will not receive any treatment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Measured: Immediately after the intervention
Neurophysiological measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV).
Measured: Immediately after the intervention
Neurophysiological measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms).
Measured: Immediately after the intervention
Neurophysiological 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 after the intervention
Neurophysiological measures - Intra-cortical facilitation
Intra-cortical facilitation (ICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Measured: Immediately after the intervention
Secondary outcomes (2)
Scapular kinematics
Scapular kinematics, including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plan elevation at 30°, 60°, 90°, and 120°, will be calculated and will be described with degree (°).
Measured: Immediately after the intervention
Scapular muscles activation
The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated over three 30° increments of motion during arm elevation from 30° to 120°, including 30° - 60°, 60° - 90°, and 90° - 120°
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start22 Oct 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
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.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin-Liang Lin, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014491
- Sponsor's protocol ID
- YM108043F
- Status last verified
- May 2021
- First submitted
- 1 Jul 2019
- Last updated
- 24 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Scapular Control and Strengthening Training on Neuromuscular Control and Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04014491
- Acronym / sponsor ID
- YM108043F
- Conditions
- Shoulder Impingement Syndrome, Transcranial Magnetic Stimulation, Central Nervous System, Biomechanical Phenomena
- Keywords
- Shoulder impingement syndrome, Transcranial magnetic stimulation, Corticospinal system, Scapular control exercise, Kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Jul 2019 (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 impingement syndrome is the most common shoulder disorder in overhead athletes. It describes a mechanical compression of subacromial bursa and rotator cuff tendons during arm movement, which results in pain and injuries. Most of previous studies focus on investigating motor performance in individuals with shoulder impingement syndrome and found altered scapular kinematics and muscle activation may contribute to the impingement. Recently few studies found changes in the central nervous system, decreases in corticospinal excitability and increases in inhibition in scapular muscles, by using transcranial magnetic stimulation (TMS). Although more studies are still needed to investigate the changes in central nervous system in the individuals with impingement syndrome, the changes in central nervous system are believed to be associated with the deficits of impingement syndrome. However, the exercise protocols for the impingement syndrome are usually designed to restore scapular kinematics and muscle activation, including scapular muscle strengthening exercise and scapular control exercise. To our knowledge, no study has investigated whether these exercise protocols can reverse these changes in the corticospinal system. The objectives of this proposal are to understand neuromuscular and neurophysiological mechanisms of the scapula-focused exercise protocols to improve the effectiveness of treatment. The study aims to investigate the effects of scapular muscle strengthening training and scapular control training on the scapular kinematics, muscle activation and corticospinal system. The study also aims to investigate whether any other cortical mechanisms are also affected by the shoulder impingement syndrome. We will recruit 70 overhead athletes with shoulder impingement syndrome and 22 healthy control athletes. Subjects with shoulder impingement syndrome will randomly receive either scapular muscle strengthening or scapular control training. When performing the exercise, subjects in the scapular control training group will receive electromyography feedback and cues but those in the strengthening training group will not. Immediate effects of these two training protocols on scapular kinematics, muscle activation, and neurophysiological measures will be tested before and after the training. Neurophysiological measures will be tested by TMS, including corticospinal excitability, cortical inhibition, intracortical inhibition, and intracortical facilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scapula control exercise | Experimental | Procedure: Scapula control exerciseSubjects will perform three exercises with EMG biofeedback and verbal cues. Three exercises are elevation in scapular plane, sidelying external rotation and dynamic hug plus |
| Scapula strengthening exercise | Experimental | Procedure: scapular strengthening exerciseThe subjects in the scapular strengthening group will be asked to perform the three exercises the same as scapula control exercise group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction. |
| Healthy subject group | Other | Other: No interventionHealthy subjects will be included to compare the differences in corticospinal system between healthy subjects and subjects with shoulder impingement syndrome, so this group will not receive any treatment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Practice overhead exercise more than six hours a week,
- Aged 20 to 40 years old,
- Have shoulder pain localized at the anterior or lateral aspect of shoulder more than two weeks,
- Have obvious medial border prominence of the scapula at 90° of arm elevation,
- Have shoulder impingement syndrome, which is confirmed by having at least two of the following: (a) positive Neer test, (b) positive Hawkins sign, (c) positive empty can test, (d) positive resisted external rotation test, and (e) tenderness of the rotator cuff tendons
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Scapula control exerciseTo perform arm elevation in the scapular plane, subjects will be first asked to correct scapular resting posture in sitting with EMG biofeedback. Then the subjects will be instructed to do elevation in the scapular plane, side lying external rotation and dynamic hug plus with control of the scapula by EMG feedback and verbal cues | Procedure or surgery | Scapula control exercise |
| scapular strengthening exerciseThe subjects in the scapular strengthening group will be asked to perform these three exercises the same as scapula control group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction. | Procedure or surgery | Scapula strengthening exercise |
| No interventionNo intervention | Other | Healthy subject group |
Primary outcome
Neurophysiological measures - Active motor threshold
Time frame: Immediately after the intervention
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Neurophysiological measures - Motor evoked potential
Time frame: Immediately after the intervention
Motor evoked potential (MEP) will be described with millivolt (mV).
Neurophysiological measures - Cortical silent period
Time frame: Immediately after the intervention
Cortical silent period (CSP) will be measured with millisecond (ms).
Neurophysiological measures - Short interval cortical inhibition
Time frame: Immediately after the intervention
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
Neurophysiological measures - Intra-cortical facilitation
Time frame: Immediately after the intervention
Intra-cortical facilitation (ICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
2 secondary outcomes
Scapular kinematics
Time frame: Immediately after the intervention
Scapular muscles activation
Time frame: Immediately after the intervention
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 24 May 2021.
- Individual participant dataSharing planned: No
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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 Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scapular strengthening exercise in people with Shoulder Impingement Syndrome and Transcranial Magnetic Stimulation, 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 15 inclusion and 0 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 24 May 2021. 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?
Neurophysiological measures - Active motor threshold (time frame: Immediately after the intervention). The study lists 5 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 24 May 2021.