Shoulder Impingement SyndromeNCT05371457
The Influences of Subscapularis Lesion on Ultrasonography and Kinematics in Patients With Shoulder Impingement
An observational study of Shoulder Impingement Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Subacromial and subcoracoid impingement have been categorized as external impingement, one type of shoulder impingement syndrome (SIS). Differentiation between subacromial impingement and subcoracoid impingement are important in determining the treatment target. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2022to 15 Jul 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Forty subjects whose age from 20 to 60 years old were recruited from National Taiwan University Hospital and through general local internet media. The inclusion criteria of subjects will be 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. In addition, participants with a history of shoulder dislocation, fracture or surgery, history of direct contact injury to the neck or upper extremities within the past month, glenohumeral joint instability (positive apprehension test, sulcus sign), neurologic disorder (upper motor neuron diseases, cervical radiculopathy), passive ER ROM less than 30 degrees and pain (visual analogue scale, VAS less than 5) during the experimental tasks will be excluded.
Who may be able to join
- Age from 20 to 60 years old
- Unilateral shoulder symptoms
- 2. 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.
Who cannot join
- Shoulder dislocation
- Fracture
- Surgery
- History of direct contact injury to the neck or upper extremities within the past month
- Glenohumeral joint instability (positive apprehension test, sulcus sign)
- Neurologic disorder (upper motor neuron diseases, cervical radiculopathy)
- Passive ER ROM less than 30 degrees
- Pain (visual analogue scale, VAS more than 5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influences of Subscapularis Lesion on Ultrasonography and Scapular Kinematics in Patients With Shoulder Impingement Syndrome
Subacromial and subcoracoid impingement have been categorized as external impingement, one type of shoulder impingement syndrome (SIS). Differentiation between subacromial impingement and subcoracoid impingement are important in determining the treatment target. The thickness of the coracohumeral ligament (CHL) may affect coracohumeral distance (CHD), which has been suggested as a possible factor in developing subcoracoid impingement with subscapularis (SSC) lesion. Evidence that indicates the existence of abnormal SSC, CHL thickness and CHD in people with SIS is limited. The purposes of the study were (1) to evaluate the correlations between CHL thickness and CHD by using ultrasonography in people with SIS with and without SSC lesion, (2) to examine the difference in SSC/CHL thickness and CHD between people with SIS with and without SSC lesion.
Read the detailed description
Based on previous studies, a total sample size of 40 participants was calculated to provide 80% power with detection of a difference of more than 1.0 mm CHD between 2 groups. The inclusion criteria of the participants were age of 20-60 years old and positive unilateral shoulder results on at least 3 of 5 tests: 1) Neer's test, 2) Hawkins' test, 3) the Empty can test, 4) the pain or weakness with resisted ER test, and 5) tenderness in the tendon of the rotator cuff. Participants with a history of shoulder dislocation, fracture or surgery, history of direct contact injury to the neck or upper extremities within the past month, glenohumeral joint instability (positive apprehension test, sulcus sign), neurologic disorder (upper motor neuron diseases, cervical radiculopathy), passive ER Range of Motion (ROM) less than 30 degrees, or pain (visual analogue scale, VAS more than 5) during the experimental tasks were excluded. After the impingement tests were performed to ensure that the participants met our inclusion criteria, all participants were assessed with 3 special SSC tests, namely, the lift-off test, belly-press test (Napoleon sign) and bear-hug test, for group allocation. Patients with positive results on at least 2 of the 3 special tests were allocated to the SSC lesion (SSCL) group.
The characteristics of the participants were collected by one assessor, including age, gender, height, weight, dominant side, involved side, duration of symptom, pain (VAS), occupation ratio, the Flexilevel Scale of Shoulder Function (FLEX-SF) and internal rotator strength.
USG measurements We measured the following outcomes: (1) CHL thickness, (2) CHD and (3) AHD. Each outcome was measured in 3 trials and the mean of the 3 trials was used for data analyses. All of the measurements were measured with THI turned on except for that of CHD, due to the deeper anatomical structure.
For measurement of the CHL thickness, the position of the linear probe was on the lateral border of the coracoid process to obtain a longitudinal image of the CHL. Each participant was instructed to lie in supine position and relax while the examiner maintained the elbow of the participant at flexion of 90° and the shoulder under maximal ER without shoulder abduction or flexion (arm by side) (Figure 2). Maximal ER of the shoulder was achieved when the examiner could not further externally rotate the shoulder of the participant. The thickness of the CHL at a 2-mm distance from the coracoid process was measured.
CHD was measured with the probe positioned on the lateral border of the coracoid process to obtain images of the coracoid process and humeral head in 4 different shoulder rotation positions: (1) shoulder neutral rotation (CHD-NR), (2) external rotation (CHD-ER) and (3) shoulder internal rotation with maximal forward flexion and full adduction (CHD-IRFA, with the arm adducted across the chest reaching for the opposite shoulder) and (4) shoulder internal rotation (CHD-IR) (Figure 2). Participants were asked to sit with their arms by their sides and to perform the 4 different positions respectively. The measurements were repeated for 3 trials with repositioning of the arm to a neutral position for intervals of 10 seconds. The distance measured was that between the coracoid process and the lesser tuberosity of the humerus.
SSP tendon thickness was evaluated with the patient's palm placed over his/her iliac wing, or "back pocket", with the elbow flexed and directed medially. The transducer was placed over the anterior aspect of the shoulder, perpendicular to the supraspinatus tendon and just anterior of the anterior-lateral margin of the acromion. A transverse glide was then performed at the site to determine the exact position where the observer judged that the tendon thickness was at its maximum. The thickness of the SSP tendon was measured 2 cm away from the biceps long head tendon. For measuring SSC tendon thickness with a short axis of view, the probe was positioned horizontally on the bicipital grove. The participant's forearm was placed with the elbow flexed to 90° in slight internal rotation, with the palm facing upward and medially. Then the patient was asked to rotate the forearm externally, keeping the palm up and the elbow strictly close to the iliac crest.
Acrociohumeral distance (AHD) was measured under 0° and 60° of scapular plane shoulder elevation. The transducer was placed on the most anterior aspect of the acromion edge, with the long axis of the transducer placed in the plane of the scapula and parallel to the flat surface of the acromion. The participants sat in an upright position without back support and with their feet flat on the floor, holding their shoulders back and looking straight ahead, to achieve retracted shoulders and extension in the thoracic and cervical spine. AHD was measured at 0° and 60° of active shoulder elevation in the scapular plane. A 60° scapular elevation of AHD was then measured with a goniometer placed on the patient's arm to determine 60° of active shoulder elevation, with the thumb pointing up.
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder impingement syndrome, subcoracoid impingement, coracohumeral ligament distance, subscapularis
- Medical subject headings
- Shoulder Impingement Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of Coracohumeral Ligament (CHL)
The T3300 ultrasound system (BenQ, Taipei, Taiwan) is a portable ultrasonography machine to collect thickness of CHL as well as CHD. B-mode US depicts the CHL as a linear hyperechoic band surrounded by hyperechoic fat. Differentiation of the CHL from surrounding tissues can be achieved by tilting the probe to show anisotropy and by dynamic examination IR and ER. The CHL will be loosened (concave) in IR and tightened (straight) in ER. During the maximal ER, the thickness of the CHL at a 2-mm distance from the coracoid process will be measured.
Measured: Baseline
Coracohumeral Distance (CHD)
CHD was measured with the probe positioned on the lateral border of the coracoid process to obtain images of the coracoid process and humeral head in 4 different shoulder rotation positions: (1) shoulder neutral rotation (CHD-NR), (2) external rotation (CHD-ER) and (3) shoulder internal rotation with maximal forward flexion and full adduction (CHD-IRFA, with the arm adducted across the chest reaching for the opposite shoulder) and (4) shoulder internal rotation (CHD-IR). Participants were asked to sit with their arms by their sides and to perform the 4 different positions respectively. The measurements were repeated for 3 trials with repositioning of the arm to a neutral position for intervals of 10 seconds. The distance measured was that between the coracoid process and the lesser tuberosity of the humerus. The distance will be measured in the shortest distance between the interval of coracoid process and the lesser tuberosity of the humerus.
Measured: Baseline
Long Head of Biceps Tendon (LHBT) Stability
dynamic stability assessment and presence of "chondral print" will be measured for LHBT stability. The probe will be placed at the level of bicipital groove and slightly move upward for short axis image (dynamic stability and "chondral print") and orientated perpendicularly between the bicipital groove for long axis image ("chondral print"). The participant's forearm is placed with the supinated elbow flexed 90° and 10° of IR. Then, the LHBT transposition will be recorded while asking the participant to externally and internally rotation of GH joint for dynamic stability assessment. For "chondral print" evaluation, investigate the presence of irregularity of bicipital groove under short and long axis view.
Measured: Baseline
Humerus elevation
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) is an electromagnetic motion analysis system with Motion Monitor software which is used to collect three-dimensional scapular kinematics. The sensors will be attached to bony landmarks (sternum, the scapular acromial process, and the distal humerus between the lateral and medial epicondyles). The recording will be started with the participants in a sitting position, and two hands at the sides. Then, the participants will be asked to perform 5 trials of full ROM scapular plane elevation, and simultaneously we measuring the kinematic data. The humerus elevation, scapular upward/downward rotation, anterior/posterior tipping and internal/external rotation, elevation/depression will be calculated by the software. The kinematic data will be recorded during 30°, 60°, 90° and 120° in raising and lowering phase of humeral elevation in the scapular plane.
Measured: Baseline
Scapular upward/downward rotation
See outcome 4
Measured: Baseline
Scapular anterior/posterior tipping
See outcome 4
Measured: Baseline
Scapular internal/external rotation
See outcome 4
Measured: Baseline
Scapular elevation/depression
See outcome 4
Measured: Baseline
Scapular muscles activities
Electromyography surface silver chloride circular electrodes with an interelectrode distance of 20 mm, and a Grass AC/DC amplifier with a gain of 1,000, a common mode rejection ratio of 86 dB at 60 Hz, and a bandwidth (-3 dB) of 10 - 1,000 Hz were used. The sEMG data will be collected at 2,000 Hz/channel using a 16-bit analog to digital converter. Each electrode will be controlled with an impedance less than 10 k. The procedures of the recording of the sEMG activity are the same as the kinematic data. A RMS algorithm will be used to produces sEMG envelopes with a sampling rate of 50. Results will be normalized to the maximal activity during MVIC trials. Upper trapezius(UT), long head of biceps(LHB), lower trapezius(LT) and serratus anterior(SA) muscle activation in 0-30°, 30°-60°, 60°-90°, 90°-120° and >120° in raising and lowering phase will be recorded. The mean sEMG amplitude of each phase will be reported as a percentage of MVIC to assess the activity of each muscle.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start14 May 2022
- Primary completion15 Jun 2022
- Study completion15 Jul 2022
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 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371457
- Sponsor's protocol ID
- 202011045RIND
- Status last verified
- Dec 2021
- First submitted
- 6 Feb 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Subscapularis Lesion on Ultrasonography and Scapular Kinematics in Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT05371457
- Acronym / sponsor ID
- 202011045RIND
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder impingement syndrome, subcoracoid impingement, coracohumeral ligament distance, subscapularis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 12 May 2022 (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 and subcoracoid impingement have been categorized as external impingement, one type of shoulder impingement syndrome (SIS). Differentiation between subacromial impingement and subcoracoid impingement are important in determining the treatment target. The thickness of the coracohumeral ligament (CHL) may affect coracohumeral distance (CHD), which has been suggested as a possible factor in developing subcoracoid impingement with subscapularis (SSC) lesion. Evidence that indicates the existence of abnormal SSC, CHL thickness and CHD in people with SIS is limited. The purposes of the study were (1) to evaluate the correlations between CHL thickness and CHD by using ultrasonography in people with SIS with and without SSC lesion, (2) to examine the difference in SSC/CHL thickness and CHD between people with SIS with and without SSC lesion.
Detailed description
Based on previous studies, a total sample size of 40 participants was calculated to provide 80% power with detection of a difference of more than 1.0 mm CHD between 2 groups. The inclusion criteria of the participants were age of 20-60 years old and positive unilateral shoulder results on at least 3 of 5 tests: 1) Neer's test, 2) Hawkins' test, 3) the Empty can test, 4) the pain or weakness with resisted ER test, and 5) tenderness in the tendon of the rotator cuff. Participants with a history of shoulder dislocation, fracture or surgery, history of direct contact injury to the neck or upper extremities within the past month, glenohumeral joint instability (positive apprehension test, sulcus sign), neurologic disorder (upper motor neuron diseases, cervical radiculopathy), passive ER Range of Motion (ROM) less than 30 degrees, or pain (visual analogue scale, VAS more than 5) during the experimental tasks were excluded. After the impingement tests were performed to ensure that the participants met our inclusion criteria, all participants were assessed with 3 special SSC tests, namely, the lift-off test, belly-press test (Napoleon sign) and bear-hug test, for group allocation. Patients with positive results on at least 2 of the 3 special tests were allocated to the SSC lesion (SSCL) group.
The characteristics of the participants were collected by one assessor, including age, gender, height, weight, dominant side, involved side, duration of symptom, pain (VAS), occupation ratio, the Flexilevel Scale of Shoulder Function (FLEX-SF) and internal rotator strength.
USG measurements We measured the following outcomes: (1) CHL thickness, (2) CHD and (3) AHD. Each outcome was measured in 3 trials and the mean of the 3 trials was used for data analyses. All of the measurements were measured with THI turned on except for that of CHD, due to the deeper anatomical structure.
For measurement of the CHL thickness, the position of the linear probe was on the lateral border of the coracoid process to obtain a longitudinal image of the CHL. Each participant was instructed to lie in supine position and relax while the examiner maintained the elbow of the participant at flexion of 90° and the shoulder under maximal ER without shoulder abduction or flexion (arm by side) (Figure 2). Maximal ER of the shoulder was achieved when the examiner could not further externally rotate the shoulder of the participant. The thickness of the CHL at a 2-mm distance from the coracoid process was measured.
CHD was measured with the probe positioned on the lateral border of the coracoid process to obtain images of the coracoid process and humeral head in 4 different shoulder rotation positions: (1) shoulder neutral rotation (CHD-NR), (2) external rotation (CHD-ER) and (3) shoulder internal rotation with maximal forward flexion and full adduction (CHD-IRFA, with the arm adducted across the chest reaching for the opposite shoulder) and (4) shoulder internal rotation (CHD-IR) (Figure 2). Participants were asked to sit with their arms by their sides and to perform the 4 different positions respectively. The measurements were repeated for 3 trials with repositioning of the arm to a neutral position for intervals of 10 seconds. The distance measured was that between the coracoid process and the lesser tuberosity of the humerus.
SSP tendon thickness was evaluated with the patient's palm placed over his/her iliac wing, or "back pocket", with the elbow flexed and directed medially. The transducer was placed over the anterior aspect of the shoulder, perpendicular to the supraspinatus tendon and just anterior of the anterior-lateral margin of the acromion. A transverse glide was then performed at the site to determine the exact position where the observer judged that the tendon thickness was at its maximum. The thickness of the SSP tendon was measured 2 cm away from the biceps long head tendon. For measuring SSC tendon thickness with a short axis of view, the probe was positioned horizontally on the bicipital grove. The participant's forearm was placed with the elbow flexed to 90° in slight internal rotation, with the palm facing upward and medially. Then the patient was asked to rotate the forearm externally, keeping the palm up and the elbow strictly close to the iliac crest.
Acrociohumeral distance (AHD) was measured under 0° and 60° of scapular plane shoulder elevation. The transducer was placed on the most anterior aspect of the acromion edge, with the long axis of the transducer placed in the plane of the scapula and parallel to the flat surface of the acromion. The participants sat in an upright position without back support and with their feet flat on the floor, holding their shoulders back and looking straight ahead, to achieve retracted shoulders and extension in the thoracic and cervical spine. AHD was measured at 0° and 60° of active shoulder elevation in the scapular plane. A 60° scapular elevation of AHD was then measured with a goniometer placed on the patient's arm to determine 60° of active shoulder elevation, with the thumb pointing up.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Forty subjects whose age from 20 to 60 years old were recruited from National Taiwan University Hospital and through general local internet media. The inclusion criteria of subjects will be 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. In addition, participants with a history of shoulder dislocation, fracture or surgery, history of direct contact injury to the neck or upper extremities within the past month, glenohumeral joint instability (positive apprehension test, sulcus sign), neurologic disorder (upper motor neuron diseases, cervical radiculopathy), passive ER ROM less than 30 degrees and pain (visual analogue scale, VAS less than 5) during the experimental tasks will be excluded.
Key inclusion criteria (3 listed)
- Age from 20 to 60 years old
- Unilateral shoulder symptoms
- 2. 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.
Key exclusion criteria (8 listed)
- Shoulder dislocation
- Fracture
- Surgery
- History of direct contact injury to the neck or upper extremities within the past month
- Glenohumeral joint instability (positive apprehension test, sulcus sign)
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
Thickness of Coracohumeral Ligament (CHL)
Time frame: Baseline
The T3300 ultrasound system (BenQ, Taipei, Taiwan) is a portable ultrasonography machine to collect thickness of CHL as well as CHD. B-mode US depicts the CHL as a linear hyperechoic band surrounded by hyperechoic fat. Differentiation of the CHL from surrounding tissues can be achieved by tilting the probe to show anisotropy and by dynamic examination IR and ER. The CHL will be loosened (concave) in IR and tightened (straight) in ER. During the maximal ER, the thickness of the CHL at a 2-mm distance from the coracoid process will be measured.
Coracohumeral Distance (CHD)
Time frame: Baseline
CHD was measured with the probe positioned on the lateral border of the coracoid process to obtain images of the coracoid process and humeral head in 4 different shoulder rotation positions: (1) shoulder neutral rotation (CHD-NR), (2) external rotation (CHD-ER) and (3) shoulder internal rotation with maximal forward flexion and full adduction (CHD-IRFA, with the arm adducted across the chest reaching for the opposite shoulder) and (4) shoulder internal rotation (CHD-IR). Participants were asked to sit with their arms by their sides and to perform the 4 different positions respectively. The measurements were repeated for 3 trials with repositioning of the arm to a neutral position for intervals of 10 seconds. The distance measured was that between the coracoid process and the lesser tuberosity of the humerus. The distance will be measured in the shortest distance between the interval of coracoid process and the lesser tuberosity of the humerus.
Long Head of Biceps Tendon (LHBT) Stability
Time frame: Baseline
dynamic stability assessment and presence of "chondral print" will be measured for LHBT stability. The probe will be placed at the level of bicipital groove and slightly move upward for short axis image (dynamic stability and "chondral print") and orientated perpendicularly between the bicipital groove for long axis image ("chondral print"). The participant's forearm is placed with the supinated elbow flexed 90° and 10° of IR. Then, the LHBT transposition will be recorded while asking the participant to externally and internally rotation of GH joint for dynamic stability assessment. For "chondral print" evaluation, investigate the presence of irregularity of bicipital groove under short and long axis view.
Humerus elevation
Time frame: Baseline
The Polhemus 3Space FASTRAK system (Polhemus Inc., Colchester, VT, USA) is an electromagnetic motion analysis system with Motion Monitor software which is used to collect three-dimensional scapular kinematics. The sensors will be attached to bony landmarks (sternum, the scapular acromial process, and the distal humerus between the lateral and medial epicondyles). The recording will be started with the participants in a sitting position, and two hands at the sides. Then, the participants will be asked to perform 5 trials of full ROM scapular plane elevation, and simultaneously we measuring the kinematic data. The humerus elevation, scapular upward/downward rotation, anterior/posterior tipping and internal/external rotation, elevation/depression will be calculated by the software. The kinematic data will be recorded during 30°, 60°, 90° and 120° in raising and lowering phase of humeral elevation in the scapular plane.
Scapular upward/downward rotation
Time frame: Baseline
See outcome 4
Scapular anterior/posterior tipping
Time frame: Baseline
See outcome 4
Scapular internal/external rotation
Time frame: Baseline
See outcome 4
Scapular elevation/depression
Time frame: Baseline
See outcome 4
Scapular muscles activities
Time frame: Baseline
Electromyography surface silver chloride circular electrodes with an interelectrode distance of 20 mm, and a Grass AC/DC amplifier with a gain of 1,000, a common mode rejection ratio of 86 dB at 60 Hz, and a bandwidth (-3 dB) of 10 - 1,000 Hz were used. The sEMG data will be collected at 2,000 Hz/channel using a 16-bit analog to digital converter. Each electrode will be controlled with an impedance less than 10 k. The procedures of the recording of the sEMG activity are the same as the kinematic data. A RMS algorithm will be used to produces sEMG envelopes with a sampling rate of 50. Results will be normalized to the maximal activity during MVIC trials. Upper trapezius(UT), long head of biceps(LHB), lower trapezius(LT) and serratus anterior(SA) muscle activation in 0-30°, 30°-60°, 60°-90°, 90°-120° and >120° in raising and lowering phase will be recorded. The mean sEMG amplitude of each phase will be reported as a percentage of MVIC to assess the activity of each muscle.
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 18 Jul 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.
Jiu- Jenq Lin, PHD principal investigator
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
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 Shoulder Impingement Syndrome, 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 3 inclusion and 8 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 18 Jul 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?
Thickness of Coracohumeral Ligament (CHL) (time frame: Baseline). The study lists 9 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 18 Jul 2022.