Shoulder ImpingementNCT03252444
Therapeutic Approaches for Subjects With Scapula Dyskinesis
A study of Shoulder Impingement, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Impingement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Mar 2015to 21 May 2017
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
- Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms
Who cannot join
- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Approaches for Subjects With Scapula Dyskinesis: Conscious Control, EMG Biofeedback Training, and Intensive Scapula-focused Intervention
The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.
- Conditions
- Shoulder Impingement
- Being tested
- Conscious control, Conscious control+biofeedback
- Keywords
- Shoulder dyskinesis, EMG biofeedback training, Intensive Scapula-focused intervention
- 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.
Conscious controlOther
Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues
Conscious control+biofeedbackOther
In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback group | Experimental | After 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis. After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises. Receives: Other: Conscious control+biofeedback |
| Conscious control group | Active comparator | Conscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies. The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt. Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis Receives: Other: Conscious control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder complex kinematics
Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping). Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation. Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.
Measured: The scapular kinematics will be measured before scapular control and immediately after scapular control
Shoulder associated muscular activities
Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)
Measured: The muscle activation will be measured before scapular control and immediately after scapular control
Secondary outcomes (2)
Forward shoulder posture
The measurement of the distance between the posterior border of the acromion and the table
Measured: After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
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
Measured: After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start25 Mar 2015
- Primary completion21 May 2017
- Study completion21 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiu- Jenq Lin, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252444
- Sponsor's protocol ID
- 201412043RINA
- Status last verified
- Aug 2017
- First submitted
- 9 Aug 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Du WY, Huang TS, Chiu YC, Mao SJ, Hung LW, Liu MF, Yang JL, Lin JJ. Single-Session Video and Electromyography Feedback in Overhead Athletes With Scapular Dyskinesis and Impingement Syndrome. J Athl Train. 2020 Mar;55(3):265-273. doi: 10.4085/1062-6050-490-18. Epub 2019 Dec 26.
PubMed 31876455
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Approaches for Subjects With Scapula Dyskinesis: Conscious Control, EMG Biofeedback Training, and Intensive Scapula-focused Intervention
- ClinicalTrials.gov ID
- NCT03252444
- Acronym / sponsor ID
- 201412043RINA
- Conditions
- Shoulder Impingement
- Keywords
- Shoulder dyskinesis, EMG biofeedback training, Intensive Scapula-focused intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 21 May 2017 (actual)
- Study completion
- 21 May 2017 (actual)
- First posted
- 17 Aug 2017 (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.
The investigators will test whether conscious control with manual guides and video or EMG biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with different type of scapula dyskinesis. The investigators will also examine how correction of scapular orientation may affect the activation of associated muscles during various dynamic movements in these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback group | Experimental | Other: Conscious control+biofeedbackAfter 1 minute of rest, participants will perform 6 trials of bilateral, active, weighted arm elevation in the scapular plane and a therapist classifies the scapular motion into specific patterns of scapular dyskinesis. After the evaluation of scapular dyskinesis, the kinematics and surface EMG (sEMG) data will be collected during 5 trials of the same arm movements and 3 selected exercises. |
| Conscious control group | Active comparator | Other: Conscious controlConscious correction of scapular orientation will be taught to the subjects in the manner described in previous studies. The starting position is determined in each individual by actively positioning the scapula between maximal upward and downward rotation, external and internal rotation, and posterior and anterior tilt. Scapular assistance test (SAT) is also conducted by passively assisting patients' scapula into appropriate position to correct scapula dyskinesis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff and resisted external test.
- Each patient will need a prescription of the physician or orthopedic surgeon for diagnosing impingement symptoms
Key exclusion criteria (1 listed)
- Shoulder pain onset due to trauma, a history of shoulder fractures or dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, surgical interventions on the shoulder, or inflammatory arthropathy
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 |
|---|---|---|
| Conscious controlConscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues | Other | Conscious control group |
| Conscious control+biofeedbackIn electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events. | Other | Biofeedback group |
Primary outcome
Shoulder complex kinematics
Time frame: The scapular kinematics will be measured before scapular control and immediately after scapular control
Scapular orientation relative to the thorax is described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping). Scapular elevation is defined as the vertical displacement of the scapular sensor during arm elevation. Humeral orientation relative to the scapula is described using a Euler angle sequence in which the first rotation represents the plane of elevation, the second rotation defines the amount of elevation, and the third rotation describes the amount of axial rotation.
Shoulder associated muscular activities
Time frame: The muscle activation will be measured before scapular control and immediately after scapular control
Full bandwidth sEMG data, captured by data acquisition software (AcqKnowledge, Biopac systems Inc., CA, USA)
2 secondary outcomes
Forward shoulder posture
Time frame: After subjects are included in the study, the forward shoulder posture will be measured before scapular control, and be done within 2 hours.
Pectoralis minor muscle length
Time frame: After subjects are included in the study, the muscle length will be measured before scapular control, and be done within 2 hours.
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 25 Jun 2019.
- Derived from this study: PubMed 31876455Du WY, Huang TS, Chiu YC, Mao SJ, Hung LW, Liu MF, Yang JL, Lin JJ. Single-Session Video and Electromyography Feedback in Overhead Athletes With Scapular Dyskinesis and Impingement Syndrome. J Athl Train. 2020 Mar;55(3):265-273. doi: 10.4085/1062-6050-490-18. Epub 2019 Dec 26.
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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.
Jiu- Jenq Lin, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Shoulder Impingement, 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 25 Jun 2019. 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?
Shoulder complex kinematics (time frame: The scapular kinematics will be measured before scapular control and immediately after scapular control). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252444, which also lists 1 linked publication.
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 25 Jun 2019.