Unilateral Shoulder Pain With and Without Scapular DyskinesisNCT01962727
Scapular Dyskinesis: a Reliability and Validity Study of Comprehensive Classification Test
An observational study of Unilateral Shoulder Pain With and Without Scapular Dyskinesis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Study Design: Clinical measurement (cross-sectional) Objectives: The purpose of this study was to investigate the reliability and validity of the novel scapular dyskinesis classification test. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Unilateral Shoulder Pain With and Without Scapular Dyskinesis
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Oct 2012
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sixty subjects (36 males and 14 females, age: 22.5 ± 2.6) were recruited.Potential participants from outpatient clinic in a University hospital and local internet media were evaluated and recruited. They read and signed the informed consent approved by the Hospital institutional review boards.
Who may be able to join
- (1) they were from 18 to 50 years old and (2) they had unilateral shoulder pain around shoulder complex during activities.
Who cannot join
- history of shoulder dislocation, fracture, or shoulder surgery within past 1 year, or a history of direct contact injury to the neck if upper extremities within the past 1 month, scoliosis or excessive kyphosis, neurological disorders, body mass index (BMI)≧25, or demonstrate pain (VAS>3) during overall testing procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Study Design: Clinical measurement (cross-sectional)
Objectives: The purpose of this study was to investigate the reliability and validity of the novel scapular dyskinesis classification test.
Read more
Background: A visual-based clinical assessment with sufficient reliability and validity to identify scapular dyskinesis provides information for rehabilitation treatment.
Methods: A visual-based palpation method was evaluated by two independent physiotherapists in 60 subjects with unilateral shoulder pain to test reliability. This method classified the scapular movements during arm raising/lowing movements in scapular plane as single abnormal scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of scapular dyskinesis were also validated by corresponding alternation of the scapular kinematics and muscular activities assessed by electromagnetic motion-capturing system and surface electromyography (EMG).
Read the detailed description
No other detailed description
- Keywords
- scapular dyskinesis, kinematics, muscular activities
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of scapular dyskinesis test
The inter-rater reliability for the comprehensive scapular dyskinesis classification test was described using percentage of agreement and κ coefficient.
Rating of scapular dyskinesis was evaluated and classified into 8 patterns including(A) patterns I (B) patterns II (C) pattern III (D) pattern IV (E) pattern I+II (F) pattern II+III (G) pattern I+III (H) pattern I+II+III.
Measured: 2 hours
Secondary outcomes (1)
Validity of scapular dyskinesis test
Different patterns of scapular dyskinesis were validated by corresponding alternation of the scapular kinematics and muscular activities assessed by electromagnetic motion-capturing system and surface electromyography.
To quantitatively characterize the scapular kinematics and muscular activities, the kinematic data at 30°, 60°, 90°, and 120° and EMG data at 0~30°, 30°~60°, 60°~90°, 90°~120°, and >120° in the raising and lowering phases of humeral movement in the scapular plane were used as dependent variables. Data from the same scapular dyskinesis pattern assessed by 2 raters were used for validity analysis.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
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 Unilateral Shoulder Pain With and Without 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 60 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, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, 100 Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962727
- Sponsor's protocol ID
- 201112034RIB
- Status last verified
- Oct 2013
- First submitted
- 12 Aug 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang TS, Ou HL, Huang CY, Lin JJ. Specific kinematics and associated muscle activation in individuals with scapular dyskinesis. J Shoulder Elbow Surg. 2015 Aug;24(8):1227-34. doi: 10.1016/j.jse.2014.12.022. Epub 2015 Feb 19.
PubMed 25704212
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Dyskinesis: a Reliability and Validity Study of Comprehensive Classification Test
- ClinicalTrials.gov ID
- NCT01962727
- Acronym / sponsor ID
- 201112034RIB
- Keywords
- scapular dyskinesis, kinematics, muscular activities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Oct 2013 (estimated)
- 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.
Study Design: Clinical measurement (cross-sectional)
Objectives: The purpose of this study was to investigate the reliability and validity of the novel scapular dyskinesis classification test.
Background: A visual-based clinical assessment with sufficient reliability and validity to identify scapular dyskinesis provides information for rehabilitation treatment.
Methods: A visual-based palpation method was evaluated by two independent physiotherapists in 60 subjects with unilateral shoulder pain to test reliability. This method classified the scapular movements during arm raising/lowing movements in scapular plane as single abnormal scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of scapular dyskinesis were also validated by corresponding alternation of the scapular kinematics and muscular activities assessed by electromagnetic motion-capturing system and surface electromyography (EMG).
Detailed description
No other detailed description
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sixty subjects (36 males and 14 females, age: 22.5 ± 2.6) were recruited.Potential participants from outpatient clinic in a University hospital and local internet media were evaluated and recruited. They read and signed the informed consent approved by the Hospital institutional review boards.
Key inclusion criteria (1 listed)
- (1) they were from 18 to 50 years old and (2) they had unilateral shoulder pain around shoulder complex during activities.
Key exclusion criteria (1 listed)
- history of shoulder dislocation, fracture, or shoulder surgery within past 1 year, or a history of direct contact injury to the neck if upper extremities within the past 1 month, scoliosis or excessive kyphosis, neurological disorders, body mass index (BMI)≧25, or demonstrate pain (VAS>3) during overall testing procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reliability of scapular dyskinesis test
Time frame: 2 hours
The inter-rater reliability for the comprehensive scapular dyskinesis classification test was described using percentage of agreement and κ coefficient. Rating of scapular dyskinesis was evaluated and classified into 8 patterns including(A) patterns I (B) patterns II (C) pattern III (D) pattern IV (E) pattern I+II (F) pattern II+III (G) pattern I+III (H) pattern I+II+III.
1 secondary outcome
Validity of scapular dyskinesis test
Time frame: 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 14 Oct 2013.
- Derived from this study: PubMed 25704212Huang TS, Ou HL, Huang CY, Lin JJ. Specific kinematics and associated muscle activation in individuals with scapular dyskinesis. J Shoulder Elbow Surg. 2015 Aug;24(8):1227-34. doi: 10.1016/j.jse.2014.12.022. Epub 2015 Feb 19.
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
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, 100 Taipei, Taiwan
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 Unilateral Shoulder Pain With and Without 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 1 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 14 Oct 2013. 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?
Reliability of scapular dyskinesis test (time frame: 2 hours). 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 NCT01962727, 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 14 Oct 2013.