Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)NCT03413488
Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome
A study testing kinesio taping and exercise in people with Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)
- What is being tested?
- kinesio taping and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jan 2018to 18 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects age between 20 and 75
- Diagnosed with shoulder impingement syndrome
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff
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
- Inflammatory arthropathy
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome.
Read the detailed description
Background: Poor posture and abnormal scapular kinematics have been suggested as possible primary factors in developing Shoulder impingement syndrome (SIS) and also as secondary observed phenomena of SIS. Round shoulder posture (RSP) is major and common posture contributing to increase the potential for subacromial impingement or exaggerate the symptoms of SIS. Objective: To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing RSP and improving symptoms in subjects with SIS/RSP. Methods: Forty subjects with impingement age between 20 and 75 are recruited and measured on acromial distance, pectoralis minor index (PMI), posterior and anterior shoulder tightness, distance of scapular medial border, pain score and flexilevel scale of shoulder function (FLEX-SF). Clinical significance: Shoulder impingement syndrome (SIS) have been identified as the majority of reported shoulder complaints. The project will provide an effective intervention for subjects with SIS/RSP.
- Being tested
- kinesio taping, exercise
- Keywords
- Shoulder impingement syndrome, Kinesio tape, Round shoulder posture
- 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.
kinesio tapingOther
Apply exercise and kinesio taping for intervention
exerciseOther
Apply only exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping | Experimental | subject with shoulder impingement syndrome Receives: Other: kinesio taping |
| Exercise | Active comparator | subject with shoulder impingement syndrome Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the pectoralis minor
The Pectoralis minor index (PMI) is calculated by dividing the resting muscle length by the subject's height and multiplying by 100.
Measured: 1 year
Acromial distance (AD)
Acromial distance is defined as the distance from table to border of lateral-inferior acromion and measured in centimeter.
Measured: 1 year
Posterior and anterior shoulder tightness
Flexibility of the posterior and anterior shoulder tissues, measured in degree
Measured: 1 year
Distance of scapular medial border
The distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thoracic wall in millimeter respectively
Measured: 1 year
Self-reported flexilevel scale of shoulder function (FLEX-SF)
FLEX-SF is used to assess shoulder function and disability. Scores will be recorded from 1, with the most limited function, to 50, without any limited function in the subject.
Measured: 1 year
Pain score
Severity of pain is measured by Visual Analogue Scale, providing a range of scores from 0-10.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start16 Jan 2018
- Primary completion14 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)Studies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing-Lan Yang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413488
- Sponsor's protocol ID
- 201705117RIND
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome
- ClinicalTrials.gov ID
- NCT03413488
- Acronym / sponsor ID
- 201705117RIND
- Keywords
- Shoulder impingement syndrome, Kinesio tape, Round shoulder posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 29 Jan 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.
To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome.
Detailed description
Background: Poor posture and abnormal scapular kinematics have been suggested as possible primary factors in developing Shoulder impingement syndrome (SIS) and also as secondary observed phenomena of SIS. Round shoulder posture (RSP) is major and common posture contributing to increase the potential for subacromial impingement or exaggerate the symptoms of SIS. Objective: To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing RSP and improving symptoms in subjects with SIS/RSP. Methods: Forty subjects with impingement age between 20 and 75 are recruited and measured on acromial distance, pectoralis minor index (PMI), posterior and anterior shoulder tightness, distance of scapular medial border, pain score and flexilevel scale of shoulder function (FLEX-SF). Clinical significance: Shoulder impingement syndrome (SIS) have been identified as the majority of reported shoulder complaints. The project will provide an effective intervention for subjects with SIS/RSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping | Experimental | Other: kinesio tapingsubject with shoulder impingement syndrome |
| Exercise | Active comparator | Other: exercisesubject with shoulder impingement syndrome |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects age between 20 and 75
- Diagnosed with shoulder impingement syndrome
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff
Key exclusion criteria (6 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
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 |
|---|---|---|
| kinesio tapingApply exercise and kinesio taping for intervention | Other | Kinesio taping |
| exerciseApply only exercise intervention | Other | Exercise |
Primary outcome
Length of the pectoralis minor
Time frame: 1 year
The Pectoralis minor index (PMI) is calculated by dividing the resting muscle length by the subject's height and multiplying by 100.
Acromial distance (AD)
Time frame: 1 year
Acromial distance is defined as the distance from table to border of lateral-inferior acromion and measured in centimeter.
Posterior and anterior shoulder tightness
Time frame: 1 year
Flexibility of the posterior and anterior shoulder tissues, measured in degree
Distance of scapular medial border
Time frame: 1 year
The distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thoracic wall in millimeter respectively
Self-reported flexilevel scale of shoulder function (FLEX-SF)
Time frame: 1 year
FLEX-SF is used to assess shoulder function and disability. Scores will be recorded from 1, with the most limited function, to 50, without any limited function in the subject.
Pain score
Time frame: 1 year
Severity of pain is measured by Visual Analogue Scale, providing a range of scores from 0-10.
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 Jun 2019.
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.
Jing-Lan Yang 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 testing kinesio taping and exercise in people with Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP), 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 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 20 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?
Length of the pectoralis minor (time frame: 1 year). The study lists 6 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 Jun 2019.