Shoulder PainNCT02688205
Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain
An observational study of Shoulder Pain, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life. Many tests were used for physical examination of the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Cyriax's functional examination and Ultrasound examination
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2015
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with or without shoulder pain
Who may be able to join
- Study group:
- patients with unilateral or bilateral shoulder pain with unknown causes;
- age≥ 20 years old.
- Control group:
- patients without unilateral or bilateral shoulder pain;
- age≥ 20 years old.
Who cannot join
- 1) chronic inflammatory joint disease, infections or tumors of the shoulder, previous fracture or surgery of shoulder, and referred pain from cervical origin or visceral organs.
Trial locations and contacts
1 site in 1 country.
About this study
Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life.
Many tests were used for physical examination of the shoulder. The reliability and validity of the tests have been studied before. However, a systemic review concluded that there was conflicting evidence in reliability of each or combined tests. Functional examination of the shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.
As far as the investigators know, correlation of Cyriax functional examination with the ultrasonographic findings has never been reported before. Therefore, the aim of this study is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings in patients with shoulder pain.
Read the detailed description
There are two groups with fifty patients in each group. First group is patients who have unilateral or bilateral shoulder pain from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital. The other group is control group who has no shoulder problems. Both groups will receive Cyriax's functional examination of the shoulder after history taking, and will be examined by shoulder ultrasound in one week.
- Conditions
- Shoulder Pain
- Being tested
- Cyriax's functional examination, Ultrasound examination
- Keywords
- Cyriax's functional examination, Ultrasound, Correlation, Resisted test
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyriax's functional examinationOther
included active range of motion, passive range of motion, resisted test and accessory test for shoulder pain evaluation
Ultrasound examinationDevice
to evaluate rotator cuff, acromio-clavicular joint, and subdeltoid-subacromial bursa
| Study group | Role | What they receive |
|---|---|---|
| Shoulder pain group | The participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week. Receives: Other: Cyriax's functional examination; Device: Ultrasound examination | |
| Without shoulder pain group | The participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week. Receives: Other: Cyriax's functional examination; Device: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyriax's functional examination for diagnosis
After Cyriax's functional examination for evaluating shoulder pain, a clinical diagnosis is made by the physician
Measured: 1 week
Ultrasound examination for diagnosis
Ultrasound examination is done in one week after Cyriax's functional examination for detailed shoulder pathology evaluation.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688205
- Sponsor's protocol ID
- 20140107R
- Other IDs
- SKH-8302-103-DR-37
- Status last verified
- Feb 2016
- First submitted
- 15 May 2015
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cyriax's Functional Examination and Ultrasound Examination in Patients With Shoulder Pain
- ClinicalTrials.gov ID
- NCT02688205
- Acronym / sponsor ID
- 20140107R
- Conditions
- Shoulder Pain
- Keywords
- Cyriax's functional examination, Ultrasound, Correlation, Resisted test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Feb 2016 (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.
Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life.
Many tests were used for physical examination of the shoulder. The reliability and validity of the tests have been studied before. However, a systemic review concluded that there was conflicting evidence in reliability of each or combined tests. Functional examination of the shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It includes three arm elevation, three tests for glenohumeral joints, and six resisted tests.
As far as the investigators know, correlation of Cyriax functional examination with the ultrasonographic findings has never been reported before. Therefore, the aim of this study is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings in patients with shoulder pain.
Detailed description
There are two groups with fifty patients in each group. First group is patients who have unilateral or bilateral shoulder pain from the outpatient clinic of Department of Physical Medicine and Rehabilitation in Shin Kong Wu Ho-Su Memorial Hospital. The other group is control group who has no shoulder problems. Both groups will receive Cyriax's functional examination of the shoulder after history taking, and will be examined by shoulder ultrasound in one week.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder pain group | – | Other: Cyriax's functional examination, Device: Ultrasound examinationThe participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week. |
| Without shoulder pain group | – | Other: Cyriax's functional examination, Device: Ultrasound examinationThe participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without shoulder pain
Key inclusion criteria (6 listed)
- patients with unilateral or bilateral shoulder pain with unknown causes;
- age≥ 20 years old.
- patients without unilateral or bilateral shoulder pain;
- age≥ 20 years old.
Key exclusion criteria (1 listed)
- 1) chronic inflammatory joint disease, infections or tumors of the shoulder, previous fracture or surgery of shoulder, and referred pain from cervical origin or visceral organs.
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 |
|---|---|---|
| Cyriax's functional examinationincluded active range of motion, passive range of motion, resisted test and accessory test for shoulder pain evaluation | Other | Shoulder pain group, Without shoulder pain group |
| Ultrasound examinationto evaluate rotator cuff, acromio-clavicular joint, and subdeltoid-subacromial bursa | Device | Shoulder pain group, Without shoulder pain group |
Primary outcome
Cyriax's functional examination for diagnosis
Time frame: 1 week
After Cyriax's functional examination for evaluating shoulder pain, a clinical diagnosis is made by the physician
Ultrasound examination for diagnosis
Time frame: 1 week
Ultrasound examination is done in one week after Cyriax's functional examination for detailed shoulder pathology evaluation.
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 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Pain
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Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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Hemiplegic Shoulder Pain
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.
Lin-Fen Hsieh, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
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 Pain, run by Shin Kong Wu Ho-Su Memorial 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 6 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 23 Dec 2020. 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?
Cyriax's functional examination for diagnosis (time frame: 1 week). 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?
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 23 Dec 2020.