Shoulder PainNCT01956968
Flexibility, Range of Motion and Strength Among Patients With Differing Response to the Scapular and Humeral Assistance Tests
An observational study of Shoulder Pain, run by Meir Medical Center at 1 site in Israel.
Trial summary
Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2013to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 130 subjects referred to physical therapy due to shoulder pain.
Who may be able to join
- Age 18 years or older, main complaint of shoulder pain, ability to elevate arm in the scapular plane to at least 135 degrees, pain during scapular plane elevation, can read Hebrew.
Who cannot join
- Signs or symptoms suggesting cervical spine origin, previous fracture around shoulder complex, traumatic onset of shoulder pain, Fibromyalgia, Rheumatiod arthritis, previous shoulder surgery, loss of 50% or more of passive range of motion in 2 or more planes of motion, positive lag signs, positive apprehension test, pregnancy.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bat-Yamon Physical Therapy Clinic - Clalit Health Services
Bat Yam
About this study
Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Therefore identifying any abnormal arm or scapular movement, as well as any impairments that are associated with them can help clinicians plan a proper management strategy for patients presenting with shoulder disorders. Our hypothesis is that specific impairments will be associated with abnormal arm movement, while other impairments will be associated with abnormal scapular movement among patients with shoulder pain.
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Scapular dyskinesia, Physical examination
- Medical subject headings
- Shoulder Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder internal rotation range of motion
Measurement of supine glenohumeral internal rotation range of motion.
Measured: Baseline
Posterior capsule flexibility
Measurement of sidelying glenohumeral horizontal adduction
Measured: Baseline
Pectoralis minor resting length
Distance from coracoid process to 4th rib attachment onto sternum
Measured: Baseline
Scapular dyskinesis
Visual assessment and classification of scapular movement pattern
Measured: Baseline
Scapular upward rotation range of motion
Measured by the use of an inclinometer placed on top of scapular spine during various degrees of glenohumeral elevation angles.
Measured: Baseline
Shoulder elevation torque
Measured with a hand-held dynamometer
Measured: Baseline
Shoulder external rotator torque
Measured with a hand-held dynamometer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alon Rabin, PhD, Study director, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956968
- Sponsor's protocol ID
- MMC13028-13KCTIL
- Status last verified
- Apr 2014
- First submitted
- 15 Sep 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexibility, Range of Motion and Strength Among Patients With Differing Response to the Scapular and Humeral Assistance Tests
- ClinicalTrials.gov ID
- NCT01956968
- Acronym / sponsor ID
- MMC13028-13KCTIL
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Scapular dyskinesia, Physical examination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 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.
Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Therefore identifying any abnormal arm or scapular movement, as well as any impairments that are associated with them can help clinicians plan a proper management strategy for patients presenting with shoulder disorders. Our hypothesis is that specific impairments will be associated with abnormal arm movement, while other impairments will be associated with abnormal scapular movement among patients with shoulder pain.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 130 subjects referred to physical therapy due to shoulder pain.
Key inclusion criteria (1 listed)
- Age 18 years or older, main complaint of shoulder pain, ability to elevate arm in the scapular plane to at least 135 degrees, pain during scapular plane elevation, can read Hebrew.
Key exclusion criteria (1 listed)
- Signs or symptoms suggesting cervical spine origin, previous fracture around shoulder complex, traumatic onset of shoulder pain, Fibromyalgia, Rheumatiod arthritis, previous shoulder surgery, loss of 50% or more of passive range of motion in 2 or more planes of motion, positive lag signs, positive apprehension test, pregnancy.
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
Shoulder internal rotation range of motion
Time frame: Baseline
Measurement of supine glenohumeral internal rotation range of motion.
Posterior capsule flexibility
Time frame: Baseline
Measurement of sidelying glenohumeral horizontal adduction
Pectoralis minor resting length
Time frame: Baseline
Distance from coracoid process to 4th rib attachment onto sternum
Scapular dyskinesis
Time frame: Baseline
Visual assessment and classification of scapular movement pattern
Scapular upward rotation range of motion
Time frame: Baseline
Measured by the use of an inclinometer placed on top of scapular spine during various degrees of glenohumeral elevation angles.
Shoulder elevation torque
Time frame: Baseline
Measured with a hand-held dynamometer
Shoulder external rotator torque
Time frame: Baseline
Measured with a hand-held dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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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.
Alon Rabin, PhD study director
Ariel 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 Pain, run by Meir Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 25 Apr 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Rabin, PhD (011-972-54-7766395, alonrabin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder internal rotation range of motion (time frame: Baseline). The study lists 7 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 25 Apr 2014.