Internal Rotation Contracture-shoulderNCT03091530
Glenohumeral Rotation After Throwing: RCT Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise
A study testing Sleeper Stretch and 90/90 Hip Lift with Balloon Blow Exercise in people with Internal Rotation Contracture-shoulder, run by Duke University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. Read more about this study
- Who is it for?
- Ages 15 to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Internal Rotation Contracture-shoulder
- What is being tested?
- Sleeper Stretch and 90/90 Hip Lift with Balloon Blow Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 14 Apr 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 15 to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Active participation in competitive high school baseball at the time of study participation.
- Ability to read, write, and speak the English language.
Who cannot join
- Prior surgery to the dominant (throwing) shoulder
- Any current upper extremity injury or limitation that restricts full participation in sport
- Latex allergy secondary to use of latex material of the balloon
- Any known inability to be physically present for daily testing during the weeks of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of Glenohumeral Internal Rotation Deficit (GIRD) After Throwing: A Randomized Clinical Trail Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise
The primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study will progress the body of research related to internal rotation deficits with regards to baseball throwers. The research will be relevant to clinicians who treat patients with baseball players with internal rotation loss.
High school baseball players will be the targeted subjects for this study. They will perform two exercises (one per week) designed to increase shoulder internal rotation over the course of three weeks with one week of rest between intervention weeks. The primary outcome will be shoulder internal rotation range of motion improvements over the course of one week's time. There are no known adverse risks to either intervention.
Read the detailed description
Purpose of the Study: The primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study will progress the body of research related to internal rotation deficits with regards to baseball throwers. The research will be relevant to clinicians who treat patients with baseball players with internal rotation loss.
Specific Aim: To determine if the glenohumeral internal rotation deficit (GIRD) is more effectively restored following a throwing session by performing the sleeper stretch (SS) or the 90/90 hip lift with balloon blow exercise (BBE).
Hypothesis: BBE will improve GIRD more effectively and quickly than the SS.
This is a prospective randomized trial comparing the efficacy of two exercises designed to improve shoulder internal rotation. Subjects meeting study criteria will be randomly allocated to each group as shown in the following CONSORT allocation diagram. Randomization will be performed via random number generator.
Each subject will participate in two week-long interventions with at least one week separating the two intervention weeks. During the week of intervention, the subject will have his baseline IR measured. He will then be instructed in how to perform a single exercise designed to improve internal rotation range of motion. Approximately half of the subjects will perform the Sleeper Stretch the first week, then the Balloon Blow Exercise the second week. The remaining group of subjects will perform the Balloon Blow Exercise during the first week, then the Sleeper Stretch the second week. Both exercises will be instructed by a physical therapist who commonly prescribes the exercises in the clinical setting. A written handout detailing the exercise instructions, frequency, and duration of the stretch will be provided for the subjects' reference (submitted with IRB application). The subject will perform this exercise throughout the week as directed by study personnel. Baseline measures of glenohumeral internal rotation (IR) with the shoulder positioned at 90 degrees of abduction in the scapular plane will be obtained using a goniometer, as described by Manske. These measurements will be repeated after the initiation of the intervention exercise at the following intervals: 2 hours, 1 day, 2 days, 3 days and 4 days. All measures of IR will be taken 3 times and the average of the three measures used in data analysis. The investigator performing the measures will be blinded to participant group assignment. When the subject completes both intervention weeks, he will be asked if he had a personal preference for either exercise.
- Conditions
- Internal Rotation Contracture-shoulder
- Being tested
- Sleeper Stretch, 90/90 Hip Lift with Balloon Blow Exercise
- Keywords
- Throwing, Sleeper Stretch, Balloon Blow, GIRD (Glenohumeral internal rotation deficit)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeper StretchOther
The sleeper stretch protocol will follow the process described by Wilk with the subject lying on his throwing shoulder side, with the lateral border of the scapula on the table, and the glenohumeral and elbow joints both at 90 degrees of flexion. Participants will be instructed to passively internally rotate the shoulder with gentle overpressure applied on the dorsum of the dominant arm wrist by the nondominant hand to the point of stretch on the posterior aspect of the shoulder. Stretches will be held for 20 seconds each and repeated 4 times for optimal sustained collagen elongation. This protocol will be performed on days 0-4 after the throwing session.
90/90 Hip Lift with Balloon Blow ExerciseOther
The 90/90 Hip Lift with Balloon Blow Exercise (BBE) will follow the guidelines described by the Postural Restoration Institute. The subjects will lie supine with hips and knees flexed to 90 degrees, the right arm flexed to end range and resting on the floor. Using the left arm to hold the balloon, subjects will inhale fully and exhale into a balloon while holding a posterior pelvic tilt. The subjects inhale and then exhale into the balloon fully, then hold their breath for 5 seconds while putting their tongue on the roof of their mouth.
| Study group | Role | What they receive |
|---|---|---|
| Sleeper Stretch THEN Balloon Blow | Experimental | Sleeper Stretch CROSSOVER TO 90/90 Hip Lift with Balloon Blow Exercise Receives: Other: Sleeper Stretch; Other: 90/90 Hip Lift with Balloon Blow Exercise |
| Balloon Blow THEN Sleeper Stretch | Experimental | 90/90 Hip Lift with Balloon Blow Exercise CROSSOVER TO Sleeper Stretch Receives: Other: Sleeper Stretch; Other: 90/90 Hip Lift with Balloon Blow Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Shoulder Internal Rotation Range of Motion
Goniometric measurement of passive shoulder internal rotation
Measured: baseline, 2 hours, 1 day, 2 days, 3 days, 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Jan 2018
- Primary completion14 Apr 2018
- Study completion14 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Rotation Contracture-shoulderStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091530
- Sponsor's protocol ID
- Pro00081964
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Glenohumeral Internal Rotation Deficit (GIRD) After Throwing: A Randomized Clinical Trail Comparing the Sleeper Stretch to the 90/90 Hip Lift With Balloon Blow Exercise
- ClinicalTrials.gov ID
- NCT03091530
- Acronym / sponsor ID
- Pro00081964
- Conditions
- Internal Rotation Contracture-shoulder
- Keywords
- Throwing, Sleeper Stretch, Balloon Blow, GIRD (Glenohumeral internal rotation deficit)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 14 Apr 2018 (actual)
- First posted
- 27 Mar 2017 (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 primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study will progress the body of research related to internal rotation deficits with regards to baseball throwers. The research will be relevant to clinicians who treat patients with baseball players with internal rotation loss.
High school baseball players will be the targeted subjects for this study. They will perform two exercises (one per week) designed to increase shoulder internal rotation over the course of three weeks with one week of rest between intervention weeks. The primary outcome will be shoulder internal rotation range of motion improvements over the course of one week's time. There are no known adverse risks to either intervention.
Detailed description
Purpose of the Study: The primary purpose of this study is to determine if the loss of internal rotation following a throwing session is best restored through soft tissue stretching with the sleeper stretch or with scapular repositioning with the 90/90 hip lift with balloon blow exercise. This study will progress the body of research related to internal rotation deficits with regards to baseball throwers. The research will be relevant to clinicians who treat patients with baseball players with internal rotation loss.
Specific Aim: To determine if the glenohumeral internal rotation deficit (GIRD) is more effectively restored following a throwing session by performing the sleeper stretch (SS) or the 90/90 hip lift with balloon blow exercise (BBE).
Hypothesis: BBE will improve GIRD more effectively and quickly than the SS.
This is a prospective randomized trial comparing the efficacy of two exercises designed to improve shoulder internal rotation. Subjects meeting study criteria will be randomly allocated to each group as shown in the following CONSORT allocation diagram. Randomization will be performed via random number generator.
Each subject will participate in two week-long interventions with at least one week separating the two intervention weeks. During the week of intervention, the subject will have his baseline IR measured. He will then be instructed in how to perform a single exercise designed to improve internal rotation range of motion. Approximately half of the subjects will perform the Sleeper Stretch the first week, then the Balloon Blow Exercise the second week. The remaining group of subjects will perform the Balloon Blow Exercise during the first week, then the Sleeper Stretch the second week. Both exercises will be instructed by a physical therapist who commonly prescribes the exercises in the clinical setting. A written handout detailing the exercise instructions, frequency, and duration of the stretch will be provided for the subjects' reference (submitted with IRB application). The subject will perform this exercise throughout the week as directed by study personnel. Baseline measures of glenohumeral internal rotation (IR) with the shoulder positioned at 90 degrees of abduction in the scapular plane will be obtained using a goniometer, as described by Manske. These measurements will be repeated after the initiation of the intervention exercise at the following intervals: 2 hours, 1 day, 2 days, 3 days and 4 days. All measures of IR will be taken 3 times and the average of the three measures used in data analysis. The investigator performing the measures will be blinded to participant group assignment. When the subject completes both intervention weeks, he will be asked if he had a personal preference for either exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeper Stretch THEN Balloon Blow | Experimental | Other: Sleeper Stretch, Other: 90/90 Hip Lift with Balloon Blow ExerciseSleeper Stretch CROSSOVER TO 90/90 Hip Lift with Balloon Blow Exercise |
| Balloon Blow THEN Sleeper Stretch | Experimental | Other: Sleeper Stretch, Other: 90/90 Hip Lift with Balloon Blow Exercise90/90 Hip Lift with Balloon Blow Exercise CROSSOVER TO Sleeper Stretch |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Active participation in competitive high school baseball at the time of study participation.
- Ability to read, write, and speak the English language.
Key exclusion criteria (4 listed)
- Prior surgery to the dominant (throwing) shoulder
- Any current upper extremity injury or limitation that restricts full participation in sport
- Latex allergy secondary to use of latex material of the balloon
- Any known inability to be physically present for daily testing during the weeks of the study
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 StretchThe sleeper stretch protocol will follow the process described by Wilk with the subject lying on his throwing shoulder side, with the lateral border of the scapula on the table, and the glenohumeral and elbow joints both at 90 degrees of flexion. Participants will be instructed to passively internally rotate the shoulder with gentle overpressure applied on the dorsum of the dominant arm wrist by the nondominant hand to the point of stretch on the posterior aspect of the shoulder. Stretches will be held for 20 seconds each and repeated 4 times for optimal sustained collagen elongation. This protocol will be performed on days 0-4 after the throwing session. | Other | Balloon Blow THEN Sleeper Stretch, Sleeper Stretch THEN Balloon Blow |
| 90/90 Hip Lift with Balloon Blow ExerciseThe 90/90 Hip Lift with Balloon Blow Exercise (BBE) will follow the guidelines described by the Postural Restoration Institute. The subjects will lie supine with hips and knees flexed to 90 degrees, the right arm flexed to end range and resting on the floor. Using the left arm to hold the balloon, subjects will inhale fully and exhale into a balloon while holding a posterior pelvic tilt. The subjects inhale and then exhale into the balloon fully, then hold their breath for 5 seconds while putting their tongue on the roof of their mouth. | Other | Balloon Blow THEN Sleeper Stretch, Sleeper Stretch THEN Balloon Blow |
Primary outcome
Change In Shoulder Internal Rotation Range of Motion
Time frame: baseline, 2 hours, 1 day, 2 days, 3 days, 4 days
Goniometric measurement of passive shoulder internal rotation
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 8 May 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 90/90 Hip Lift with Balloon Blow Exercise in people with Internal Rotation Contracture-shoulder, run by Duke University 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 2 inclusion and 4 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 8 May 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?
Change In Shoulder Internal Rotation Range of Motion (time frame: baseline, 2 hours, 1 day, 2 days, 3 days, 4 days). 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 8 May 2018.