Shoulder Impingement SyndromeNCT04493190
The Effects of Short-term Scapular Control Training in Overhead Athletes With Shoulder Impingement Syndrome
A study testing General exercise in people with Shoulder Impingement Syndrome and Scapular Dyskinesis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been accounted for 44-65 % of all shoulder pain. It is believed that one important contributing factor is scapular dyskinesis. 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, Scapular Dyskinesis
- What is being tested?
- General exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2020to 26 Nov 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
- perform overhead exercise at least 4 hours a week
- present type I or II scapular dyskinesis at rest or moving
- pain at least two weeks
- 3 of 6 impingement test present positive
- Neer's impingement test: arm abduction overhead with shoulder internal rotation and thumb downward. If feel pain, then positive.
- Hawkins-Kennedy impingement Test: arm lift to horizontal plane, elbow flexion to 90 degree. Tester put force on forearm toward shoulder internal rotation. If feel pain, then positive.
Show all 12Show fewer
- Empty can test: shoulder abduction with thumb down, then give a resistive force toward up. If feel pain, then positive.
- Resistive shoulder external rotation test: elbow flexion to 90 degrees and do resistive shoulder rotation. If feel pain, then positive.
- Rotator cuff tenderness test: tester put pressure on rotator cuff. If feel pain, then positive.
- Painful arc: perform arm elevation. If feel pain during movement, then positive.
- perform overhead exercise at least 4 hours a week
- no any symptoms or injuries on shoulder and neck
Who cannot join
- 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 transcranial magnetic stimulation (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Short-term Scapular Control Training on Motor Control in Overhead Athletes With Shoulder Impingement Syndrome
Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been accounted for 44-65 % of all shoulder pain. It is believed that one important contributing factor is scapular dyskinesis. Patients with SIS demonstrates scapular dyskinesis, including decrease in upward rotation, scapular posterior tilt, and external rotation. Altered muscle activity of scapular muscles may contribute to scapular dyskinesis, such as increase in activity of upper trapezius, and decrease in activity of lower trapezius and serratus anterior. In addition to these changes in neuromuscular control, central nervous system may be re-organized in patients with musculoskeletal disorders. Evidence has been reported that center of gravity of motor mapping changes, corticospinal excitability decreases and inhibition increases in patients with shoulder injuries such as instability, rotator cuff tendinopathy and SIS. These corticospinal changes are believed to be related to chronicity of symptoms and lack of treatment effects.
Previous studies have applied many types of treatments to SIS, such as manipulation, taping, and exercises. However, most studies mainly focused on the outcomes of pain and function, few studies investigated changes in neuromuscular control following treatments. Yet, no study has addressed how corticospinal system changes following treatment in patient with shoulder injuries. Motor skill training, which has been widely used in training healthy subjects or patients with neurological disorders, has been shown to change corticospinal systems, including increasing excitability and decreasing inhibition. To our knowledge, no study has integrated the concepts of motor skill learning into a short-term treatment or investigated the effects of motor skill training on corticospinal systems in patients with SIS. The purposes of the study are to investigate the effects of short-term motor skill training on pain, neuromuscular control, corticospinal system in patients with SIS, and also to investigate whether changes in corticospinal parameters will be related to changes in pain, function and neuromuscular control.
- Conditions
- Shoulder Impingement Syndrome, Scapular Dyskinesis
- Being tested
- Scapular control training, General exercise
- Keywords
- Corticospinal excitability, Transcranial magnetic stimulation, Motor control training, Scapula-focused exercise
- 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.
Scapular control trainingProcedure or surgery
Participants in this group will learn how to maintain normal scapular position at first. Then they will progress to moving arm with good scapular control with mirror. Afterward, participants will undergo movements protocol which give different directions of arm movements while keeping scapula in a good alignment. They will also receive scapular-focused exercises. The difficulty of the movement protocol will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
General exerciseProcedure or surgery
Participants in this group will receive a general shoulder strengthening with theraband or dumbbell. Load will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
| Study group | Role | What they receive |
|---|---|---|
| Scapular control training group | Experimental | Participants in these group will be taught how to correctly movement arm overhead. And they will undergo series of movement tasks with mirror and also receive scapular-focused exercises. The difficulty of the movements protocol will increase weekly. Receives: Procedure: Scapular control training |
| General exercise group | Experimental | Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly. Receives: Procedure: General exercise |
| Healthy subject group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurophysiological measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Measured: Change from baseline AMT at 6 weeks
Change in neurophysiological measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity
Measured: Change from baseline MEP at 6 weeks
Change in neurophysiological measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms).
Measured: Change from baseline CSP at 6 weeks
Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation
Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses
Measured: Change from baseline SICI and SICF at 6 weeks
Change in shoulder pain
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Measured: Change from baseline pain at 6 weeks
Change in shoulder function
Function will be measured questionnaire, Flexilevel Scale of Shoulder Function (FLEX-SF). There are 15 questions on each difficulty version. Zero indicates the most difficulty, while 3 means the least difficulty.
Measured: Change from baseline function at 6 weeks and 3 months
Long-term change in shoulder pain
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Measured: Change from baseline pain at 3 months
Long-term change in shoulder function
Function will be measured questionnaire, FLEX-SF. There are 15 questions on each
Measured: Change from baseline pain at 3 months
Secondary outcomes (2)
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: Change from baseline scapular kinematics at 6 weeks
Scapular muscle 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: Change from baseline muscle activation at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start2 Nov 2020
- Primary completion26 Aug 2021
- Study completion26 Nov 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
- 55 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 Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493190
- Sponsor's protocol ID
- YM108159F
- Status last verified
- Apr 2022
- First submitted
- 29 Jun 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Scapular Control Training on Motor Control in Overhead Athletes With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT04493190
- Acronym / sponsor ID
- YM108159F
- Conditions
- Shoulder Impingement Syndrome, Scapular Dyskinesis
- Keywords
- Corticospinal excitability, Transcranial magnetic stimulation, Motor control training, Scapula-focused exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 30 Jul 2020 (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.
Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been accounted for 44-65 % of all shoulder pain. It is believed that one important contributing factor is scapular dyskinesis. Patients with SIS demonstrates scapular dyskinesis, including decrease in upward rotation, scapular posterior tilt, and external rotation. Altered muscle activity of scapular muscles may contribute to scapular dyskinesis, such as increase in activity of upper trapezius, and decrease in activity of lower trapezius and serratus anterior. In addition to these changes in neuromuscular control, central nervous system may be re-organized in patients with musculoskeletal disorders. Evidence has been reported that center of gravity of motor mapping changes, corticospinal excitability decreases and inhibition increases in patients with shoulder injuries such as instability, rotator cuff tendinopathy and SIS. These corticospinal changes are believed to be related to chronicity of symptoms and lack of treatment effects.
Previous studies have applied many types of treatments to SIS, such as manipulation, taping, and exercises. However, most studies mainly focused on the outcomes of pain and function, few studies investigated changes in neuromuscular control following treatments. Yet, no study has addressed how corticospinal system changes following treatment in patient with shoulder injuries. Motor skill training, which has been widely used in training healthy subjects or patients with neurological disorders, has been shown to change corticospinal systems, including increasing excitability and decreasing inhibition. To our knowledge, no study has integrated the concepts of motor skill learning into a short-term treatment or investigated the effects of motor skill training on corticospinal systems in patients with SIS. The purposes of the study are to investigate the effects of short-term motor skill training on pain, neuromuscular control, corticospinal system in patients with SIS, and also to investigate whether changes in corticospinal parameters will be related to changes in pain, function and neuromuscular control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scapular control training group | Experimental | Procedure: Scapular control trainingParticipants in these group will be taught how to correctly movement arm overhead. And they will undergo series of movement tasks with mirror and also receive scapular-focused exercises. The difficulty of the movements protocol will increase weekly. |
| General exercise group | Experimental | Procedure: General exerciseParticipants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly. |
| Healthy subject group | No intervention | –No intervention. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- perform overhead exercise at least 4 hours a week
- present type I or II scapular dyskinesis at rest or moving
- pain at least two weeks
- 3 of 6 impingement test present positive
- perform overhead exercise at least 4 hours a week
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Scapular control trainingParticipants in this group will learn how to maintain normal scapular position at first. Then they will progress to moving arm with good scapular control with mirror. Afterward, participants will undergo movements protocol which give different directions of arm movements while keeping scapula in a good alignment. They will also receive scapular-focused exercises. The difficulty of the movement protocol will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session. | Procedure or surgery | Scapular control training group |
| General exerciseParticipants in this group will receive a general shoulder strengthening with theraband or dumbbell. Load will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session. | Procedure or surgery | General exercise group |
Primary outcome
Change in neurophysiological measures - Active motor threshold
Time frame: Change from baseline AMT at 6 weeks
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Change in neurophysiological measures - Motor evoked potential
Time frame: Change from baseline MEP at 6 weeks
Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity
Change in neurophysiological measures - Cortical silent period
Time frame: Change from baseline CSP at 6 weeks
Cortical silent period (CSP) will be measured with millisecond (ms).
Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation
Time frame: Change from baseline SICI and SICF at 6 weeks
Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses
Change in shoulder pain
Time frame: Change from baseline pain at 6 weeks
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Change in shoulder function
Time frame: Change from baseline function at 6 weeks and 3 months
Function will be measured questionnaire, Flexilevel Scale of Shoulder Function (FLEX-SF). There are 15 questions on each difficulty version. Zero indicates the most difficulty, while 3 means the least difficulty.
Long-term change in shoulder pain
Time frame: Change from baseline pain at 3 months
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Long-term change in shoulder function
Time frame: Change from baseline pain at 3 months
Function will be measured questionnaire, FLEX-SF. There are 15 questions on each
2 secondary outcomes
Scapular kinematics
Time frame: Change from baseline scapular kinematics at 6 weeks
Scapular muscle activation
Time frame: Change from baseline muscle activation at 6 weeks
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 6 Apr 2022.
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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 General exercise in people with Shoulder Impingement Syndrome and Scapular Dyskinesis, 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 12 inclusion and 6 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 6 Apr 2022. 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?
Change in neurophysiological measures - Active motor threshold (time frame: Change from baseline AMT at 6 weeks). The study lists 8 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 6 Apr 2022.