Scapular DyskinesisNCT03568487
Scapula Adaption in Overhead Athletes
A study testing Intensive scapula-focused approach in people with Scapular Dyskinesis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Previous studies have proposed various ways to assess scapular dyskinesis, but they were impractical in clinical setting or the validity was questioned. The novel scapulometer we developed can measure the prominence of scapular medial border and inferior angle. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Scapular Dyskinesis
- What is being tested?
- Intensive scapula-focused approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2019to 31 Jul 2022
- 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (1) with scapular dyskinesis
- (2) overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools
Who cannot join
- if they have a history of shoulder pain or injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scapula Adaption in Overhead Athletes: Novel Scapulometer Development, Scapula Movement Adaption and Intensive Scapula-focused Intervention
Previous studies have proposed various ways to assess scapular dyskinesis, but they were impractical in clinical setting or the validity was questioned. The novel scapulometer we developed can measure the prominence of scapular medial border and inferior angle. We would like to examine its reliability and validity in subjects with symptomatic scapular dyskinesis. The long-term, high-intensity, unilateral loading may cause overhead athletes to develop adaptive changes in shoulder kinematics, range of motion (ROM) and strength in the dominant arm. We hypothesized that these changes may be related to scapular dyskinesis. According to the previous studies, we expect electromyography (EMG) biofeedback training can help improve the ratio of muscle activation of scapular muscle.
Read the detailed description
Fifty subjects of scapular dyskinesis will be classified and recruited from overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools and through local Internet media. All participants and their legal guardians will provide written informed assent and consent, respectively, and the study will be approved by the Ethics Committee Institutional Review Board. Since intervention may be specific to pattern of scapular dyskinesis, pattern of scapular dyskinesis in control group will match the pattern of scapular dyskinesis in the intervention group. Twenty-five subjects per group is based on a minimal revenant difference of a self-reported functional questionnaire between intervention and control (Struyf et al., 2013; Andersen et al., 2014). Participants will be recognized as elite players in their age categories. Subjects will be excluded if they have a history of shoulder pain or injury. Players will supply their player characteristics, including years of sports practice, weekly sports and conditioning exposure and type of sports. Players' standing height, sitting height, and body mass will be measured and used with the chronologic age to estimate their biological age according to the assessments of skeletal age, dental age, and secondary sex characteristics (Baxter et al., 2005). A clinical trial with a blinded assessor will be conducted. The subject takes a form (with a letter A or B) indicating allocation to either groups (scapula-focused approach versus control) from a closed envelop. For the scapula-approached group, pattern of scapular dyskinesis will be assessed. Then subjects in B control group will meet pattern-matched criteria related to pattern assessment of scapula-focused group. More subjects may be recruited for the control group to meet pattern-matched criteria of scapula-approached group. A list with subject numbers and the group allocation that results from this matched-control procedure will be stored in a sealed envelope. Only the therapist has direct access to the allocation list. In this way, subjects are allocated to either intervention or control group comprised of 25 subjects in each group. Both groups will be treated by the same therapist.
- Conditions
- Scapular Dyskinesis
- Being tested
- Intensive scapula-focused approach, Control Therapy
- Keywords
- scapular dyskinesis, EMG biofeedback, scapulometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive scapula-focused approachOther
scapula-focused approach with exercises, 3 x 20 min training per week for 4 weeks
Control TherapyOther
not have any physical training but is encouraged to stay active as usual.
| Study group | Role | What they receive |
|---|---|---|
| Intensive scapula-focused approach | Experimental | Not described Receives: Other: Intensive scapula-focused approach |
| Control therapy | Active comparator | Not described Receives: Other: Control Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of range of motion after 4-week training
Passive interior rotation ROM and exterior rotation ROM of the glenohumeral joint will be assessed bilaterally using a hand-held standard universal goniometer. The player will lay supine with the humerus abducted to 90 degrees and elbow flexed to 90 degrees. The fulcrum of the goniometer is set at the olecranon process.
Measured: Baseline and after 4-week training
Change of muscle strength after 4-week training
The maximal isometric strength of 8 shoulder-scapula complex muscles will be assessed bilaterally using a handheld dynamometer. Each test will be performed twice, with a 30-second rest period between tests. The largest strength value for each muscle will be used for statistical analyses, normalized to body weight (in kilograms), and expressed as a percentage for inter individual comparison.
Measured: Baseline and after 4-week training
Change of shoulder complex kinematics after 4-week training
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) will be used to record shoulder complex kinematics.
Measured: Baseline and after 4-week training
Change of muscular activities after 4-week training
Bipolar surface electromyographic (EMG) electrodes will be placed over the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) of the dominant shoulder to record muscular activities.
Measured: Baseline and after 4-week training
Secondary outcomes (2)
Forward shoulder posture (acromial distance)
The measurement of the distance between the posterior border of the acromion and the table (acromial distance) is performed in supine. In this position, the assessor measured the distance between the most posterior aspect of the posterior border of the acromion and the table bilaterally.
Measured: Baseline and after 4-week training
Pectoralis minor muscle length
The distance from the fourth rib to the coracoids process will be measured with FASTRAK system with accuracy of 0.08 cm. This distance (in centimeter) is divided by the subjects height and multiplied by 100. This results in a pectoralis muscle length index (PMI).
Measured: Baseline and after 4-week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start2 Jan 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapular DyskinesisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568487
- Sponsor's protocol ID
- 201712089RINC
- Status last verified
- May 2024
- First submitted
- 30 May 2018
- Last updated
- 20 Mar 2025
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapula Adaption in Overhead Athletes: Novel Scapulometer Development, Scapula Movement Adaption and Intensive Scapula-focused Intervention
- ClinicalTrials.gov ID
- NCT03568487
- Acronym / sponsor ID
- 201712089RINC
- Conditions
- Scapular Dyskinesis
- Keywords
- scapular dyskinesis, EMG biofeedback, scapulometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 26 Jun 2018 (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.
Previous studies have proposed various ways to assess scapular dyskinesis, but they were impractical in clinical setting or the validity was questioned. The novel scapulometer we developed can measure the prominence of scapular medial border and inferior angle. We would like to examine its reliability and validity in subjects with symptomatic scapular dyskinesis. The long-term, high-intensity, unilateral loading may cause overhead athletes to develop adaptive changes in shoulder kinematics, range of motion (ROM) and strength in the dominant arm. We hypothesized that these changes may be related to scapular dyskinesis. According to the previous studies, we expect electromyography (EMG) biofeedback training can help improve the ratio of muscle activation of scapular muscle.
Detailed description
Fifty subjects of scapular dyskinesis will be classified and recruited from overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools and through local Internet media. All participants and their legal guardians will provide written informed assent and consent, respectively, and the study will be approved by the Ethics Committee Institutional Review Board. Since intervention may be specific to pattern of scapular dyskinesis, pattern of scapular dyskinesis in control group will match the pattern of scapular dyskinesis in the intervention group. Twenty-five subjects per group is based on a minimal revenant difference of a self-reported functional questionnaire between intervention and control (Struyf et al., 2013; Andersen et al., 2014). Participants will be recognized as elite players in their age categories. Subjects will be excluded if they have a history of shoulder pain or injury. Players will supply their player characteristics, including years of sports practice, weekly sports and conditioning exposure and type of sports. Players' standing height, sitting height, and body mass will be measured and used with the chronologic age to estimate their biological age according to the assessments of skeletal age, dental age, and secondary sex characteristics (Baxter et al., 2005). A clinical trial with a blinded assessor will be conducted. The subject takes a form (with a letter A or B) indicating allocation to either groups (scapula-focused approach versus control) from a closed envelop. For the scapula-approached group, pattern of scapular dyskinesis will be assessed. Then subjects in B control group will meet pattern-matched criteria related to pattern assessment of scapula-focused group. More subjects may be recruited for the control group to meet pattern-matched criteria of scapula-approached group. A list with subject numbers and the group allocation that results from this matched-control procedure will be stored in a sealed envelope. Only the therapist has direct access to the allocation list. In this way, subjects are allocated to either intervention or control group comprised of 25 subjects in each group. Both groups will be treated by the same therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive scapula-focused approach | Experimental | Other: Intensive scapula-focused approach |
| Control therapy | Active comparator | Other: Control Therapy |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- (1) with scapular dyskinesis
- (2) overhead players (baseball, basketball, tennis, volleyball, and so on) at high schools
Key exclusion criteria (1 listed)
- if they have a history of shoulder pain or injury
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 |
|---|---|---|
| Intensive scapula-focused approachscapula-focused approach with exercises, 3 x 20 min training per week for 4 weeks | Other | Intensive scapula-focused approach |
| Control Therapynot have any physical training but is encouraged to stay active as usual. | Other | Control therapy |
Primary outcome
Change of range of motion after 4-week training
Time frame: Baseline and after 4-week training
Passive interior rotation ROM and exterior rotation ROM of the glenohumeral joint will be assessed bilaterally using a hand-held standard universal goniometer. The player will lay supine with the humerus abducted to 90 degrees and elbow flexed to 90 degrees. The fulcrum of the goniometer is set at the olecranon process.
Change of muscle strength after 4-week training
Time frame: Baseline and after 4-week training
The maximal isometric strength of 8 shoulder-scapula complex muscles will be assessed bilaterally using a handheld dynamometer. Each test will be performed twice, with a 30-second rest period between tests. The largest strength value for each muscle will be used for statistical analyses, normalized to body weight (in kilograms), and expressed as a percentage for inter individual comparison.
Change of shoulder complex kinematics after 4-week training
Time frame: Baseline and after 4-week training
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) will be used to record shoulder complex kinematics.
Change of muscular activities after 4-week training
Time frame: Baseline and after 4-week training
Bipolar surface electromyographic (EMG) electrodes will be placed over the upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) of the dominant shoulder to record muscular activities.
2 secondary outcomes
Forward shoulder posture (acromial distance)
Time frame: Baseline and after 4-week training
Pectoralis minor muscle length
Time frame: Baseline and after 4-week training
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 20 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive scapula-focused approach in people with Scapular Dyskinesis, run by National Taiwan University Hospital 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 2 inclusion and 1 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 20 Mar 2025. 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 of range of motion after 4-week training (time frame: Baseline and after 4-week training). The study lists 4 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 20 Mar 2025.