Shoulder ImpingementNCT03421535
Opposite SI Joint Stretching for GIRD
A study testing Sleeper Stretch and Opposite SI joint Stretch in people with Shoulder Impingement, run by Romano Orthopaedic Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint stretching regiment with a classically described sleeper stretch routine. Read more about this study
- Who is it for?
- Ages 23 to 25 years, men only
- Conditions the study is for
- Shoulder Impingement
- What is being tested?
- Sleeper Stretch and Opposite SI joint Stretch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 23 May 2017
- 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 23 to 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- All members a minor league baseball team
Who cannot join
- Any active shoulder or back injury or history of shoulder or back injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sacroiliac Stretching Improves Glenohumeral Internal Rotational Deficit of the Opposite Shoulder in Baseball Players in a Randomized Control Study
The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint stretching regiment with a classically described sleeper stretch routine.
Read the detailed description
Abstract:
Background:
Glenohumeral Internal Rotational Deficit (GIRD) is a well-documented finding in throwing athletes.
Hypothesis/Purpose:
The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, the effect of the SI joint stretch will be compared to that of the classically described sleeper stretch.
Study Design:
Randomized Controlled Clinical Trial
Methods:
With the athlete supine and arm abducted 90o, internal rotation of both shoulders was measured in 23 minor league baseball players.
Next, each player randomly was assigned to either a control (sleeper stretch of dominant shoulder) or experimental (stretch of the SI joint contralateral to the dominant shoulder) group supervised by a certified athletic trainer. The players performed their own stretches.
Finally, the initial two investigators, unaware of to which group the player was assigned, re-measured the end-range internal rotation of each athlete's dominant shoulder.
- Conditions
- Shoulder Impingement
- Being tested
- Sleeper Stretch, Opposite SI joint Stretch
- Keywords
- Glenohumeral internal rotational deficit, GIRD, Sleeper stretch, SI joint stretch
- 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.
Sleeper StretchProcedure or surgery
Internal Range of motion of dominant shoulder
Opposite SI joint StretchProcedure or surgery
Internal range of motion of dominant shoulder
| Study group | Role | What they receive |
|---|---|---|
| Sleeper stretch group | Active comparator | A certified athletic trainer supervised and observed the athlete as he performed the sleeper stretch on his dominant shoulder. Receives: Procedure: Sleeper Stretch |
| Opposite SI joint Stretch | Experimental | A certified athletic trainer supervised and observed the athlete as he performed the SI joint stretch opposite his dominant shoulder. Receives: Procedure: Opposite SI joint Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder internal ROM after stretching opposite SI joint
Internal range of motion of dominant shoulder after stretching opposite SI joint
Measured: Measurement made within 30 minutes of stretching
Secondary outcomes (1)
Shoulder Internal ROM after sleeper stretch
Internal range of motion of dominant shoulder after sleeper stretch
Measured: Measurement made with 30 minutes of stretching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start23 May 2017
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All 23 players of a minor league baseball team voluntarily participated in the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romano Orthopaedic Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Romano, MD, Romano Orthopaedic Center
- Investigators
- Victor Romano, Principal investigator, Romano Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421535
- Sponsor's protocol ID
- IRB#2017-087
- Status last verified
- Jan 2018
- First submitted
- 30 Dec 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PubMed 12671624Bigliani LU, Codd TP, Connor PM, Levine WN, Littlefield MA, Hershon SJ. Shoulder motion and laxity in the professional baseball player. Am J Sports Med. 1997 Sep-Oct;25(5):609-13. doi: 10.1177/036354659702500504.
PubMed 9302464
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacroiliac Stretching Improves Glenohumeral Internal Rotational Deficit of the Opposite Shoulder in Baseball Players in a Randomized Control Study
- ClinicalTrials.gov ID
- NCT03421535
- Acronym / sponsor ID
- IRB#2017-087
- Conditions
- Shoulder Impingement
- Keywords
- Glenohumeral internal rotational deficit, GIRD, Sleeper stretch, SI joint stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Romano Orthopaedic CenterUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 5 Feb 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.
The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, we aimed to compare our SI joint stretching regiment with a classically described sleeper stretch routine.
Detailed description
Abstract:
Background:
Glenohumeral Internal Rotational Deficit (GIRD) is a well-documented finding in throwing athletes.
Hypothesis/Purpose:
The purpose of this study is to investigate if stretching the contralateral sacroiliac (SI) joint improves GIRD in baseball players. Additionally, the effect of the SI joint stretch will be compared to that of the classically described sleeper stretch.
Study Design:
Randomized Controlled Clinical Trial
Methods:
With the athlete supine and arm abducted 90o, internal rotation of both shoulders was measured in 23 minor league baseball players.
Next, each player randomly was assigned to either a control (sleeper stretch of dominant shoulder) or experimental (stretch of the SI joint contralateral to the dominant shoulder) group supervised by a certified athletic trainer. The players performed their own stretches.
Finally, the initial two investigators, unaware of to which group the player was assigned, re-measured the end-range internal rotation of each athlete's dominant shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All 23 players of a minor league baseball team voluntarily participated in the study.
| Arm | Type | Receives |
|---|---|---|
| Sleeper stretch group | Active comparator | Procedure: Sleeper StretchA certified athletic trainer supervised and observed the athlete as he performed the sleeper stretch on his dominant shoulder. |
| Opposite SI joint Stretch | Experimental | Procedure: Opposite SI joint StretchA certified athletic trainer supervised and observed the athlete as he performed the SI joint stretch opposite his dominant shoulder. |
Who may qualify
- Ages
- 23 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All members a minor league baseball team
Key exclusion criteria (1 listed)
- Any active shoulder or back injury or history of shoulder or back injury
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 |
|---|---|---|
| Sleeper StretchInternal Range of motion of dominant shoulder | Procedure or surgery | Sleeper stretch group |
| Opposite SI joint StretchInternal range of motion of dominant shoulder | Procedure or surgery | Opposite SI joint Stretch |
Primary outcome
Shoulder internal ROM after stretching opposite SI joint
Time frame: Measurement made within 30 minutes of stretching
Internal range of motion of dominant shoulder after stretching opposite SI joint
1 secondary outcome
Shoulder Internal ROM after sleeper stretch
Time frame: Measurement made with 30 minutes of stretching
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 5 Feb 2018.
- Background: PubMed 12671624Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
- Background: PubMed 9302464Bigliani LU, Codd TP, Connor PM, Levine WN, Littlefield MA, Hershon SJ. Shoulder motion and laxity in the professional baseball player. Am J Sports Med. 1997 Sep-Oct;25(5):609-13. doi: 10.1177/036354659702500504.
- Individual participant dataSharing planned: No
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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.
Victor Romano principal investigator
Romano Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeper Stretch and Opposite SI joint Stretch in people with Shoulder Impingement, run by Romano Orthopaedic Center at 1 site in United States.
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 5 Feb 2018. 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 United States. 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?
Shoulder internal ROM after stretching opposite SI joint (time frame: Measurement made within 30 minutes of stretching). 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 NCT03421535, which also lists 2 linked publications.
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 5 Feb 2018.