Postoperative Posterior Shoulder TightnessNCT01810211
The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population
A study testing Horizontal Adduction Stretch and Pendulums and Modified Sleeper Stretch and Pendulum in people with Postoperative Posterior Shoulder Tightness, run by Nova Southeastern University at 1 site in United States.
Trial summary
This study will look at which, if any, active stretching procedure is most effective at correcting posterior shoulder tightness (PST) in the post-operative population. Posterior shoulder tightness can influence shoulder mobility and function within both a symptomatic and an asymptomatic population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Posterior Shoulder Tightness
- What is being tested?
- Horizontal Adduction Stretch and Pendulums and Modified Sleeper Stretch and Pendulum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Apr 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- arthroscopic shoulder surgery within the past two weeks preceding data collection with
- no surgical complications
- age 18-65.
Who cannot join
- total shoulder arthroplasty
- hemi shoulder arthroplasty
- open rotator cuff repair
- shoulder fracture fixations
- those that are unable to perform interventions and or tolerate measurement positions
- those seeking an initial evaluation after two weeks from the date of the surgical procedure.
- younger than 18
- older than 65
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeastern Orthopedics Physical Therapy
Raleigh, North Carolina, 27609
About this study
Official title: The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population: A Double Blinded Randomized Control Trial.
This study will look at which, if any, active stretching procedure is most effective at correcting posterior shoulder tightness (PST) in the post-operative population. Posterior shoulder tightness can influence shoulder mobility and function within both a symptomatic and an asymptomatic population. There are previous studies that have examined the effectiveness of different active stretching procedures and their ability to correct PST but only in the asymptomatic population. As clinicians it will be helpful to investigate their effect within a symptomatic population in order to prescribe appropriate and effective stretches within an individual's home exercise program. The study design is a double blinded randomized control trial. During evaluation a passive measurement of PST and internal rotation will be performed. Another therapist, blinded to the measurements, will randomly select which subgroup the individual will be placed in for the first three individuals and this sequence will be followed for the remainder of the participants. At this time the therapist will instruct the individual on the corresponding exercise which they will perform in front of that therapist. The individual will perform this exercise one more time that day and twice the following day and once again upon follow up prior to having internal rotation and PST measured once again. At this point this will be the conclusion of that individuals involvement in the study.
Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely in the post-operative shoulder population.
Read more
Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the post-operative population.
Null Hypothesis2: There is no significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.
Hypothesis2: There is a significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.
- Being tested
- Horizontal Adduction Stretch and Pendulums, Modified Sleeper Stretch and Pendulum
- Keywords
- Shoulder, Surgery, Posterior Shoulder Tightness, Flexibility, Range of Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal Adduction Stretch and PendulumsOther
Modified Sleeper Stretch and PendulumOther
| Study group | Role | What they receive |
|---|---|---|
| Horizontal Adduction Stretch and Pendulums | Experimental | Horizontal Adduction Stretch- Individual standing with their operative scapula against a wall and rotating toward the side to be stretched to stabilize scapula and the operative arm is relaxed. The opposite hand is placed under the elbow of the involved extremity and assists the operative shoulder into horizontal adduction attempting to bring the hand to the opposite shoulder.
Pendulum -Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. Receives: Other: Horizontal Adduction Stretch and Pendulums |
| Modified Sleeper Stretch and Pendulum | Experimental | Modified Sleeper Stretch: Individual in supine with operative shoulder abducted to approximately 45 degrees and elbow at 90 degrees of flexion with neutral rotation of the glenohumeral joint. The individual then places other hand on the wrist of the involved extremity and passively moves the glenohumeral joint into internal rotation.
Pendulum Exercise: Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. Receives: Other: Modified Sleeper Stretch and Pendulum |
| Pendulum Exercise | No intervention | Pendulum Exercise: Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclinometric Measurement of Posterior Shoulder Tightness taken in side-lying
During the initial evaluation and first follow up, PST of the operative shoulder will be measured in sidelying using an inclinometer that is attached to the mid-humerus of the patient's involved upper extremity using a Velcro strap. An inclinometer is a small device that is used to measure degrees of motion.
Measured: Initial evaluation 3 days following surgery and follow up (no longer than 72 hours from initial evaluation)
Secondary outcomes (1)
Global Rating of Change Score (GROC)
This outcome measure asks patients to rate the overall condition of their shoulder from the time they began treatment until now.
Measured: At first follow up visit no more than a week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Posterior Shoulder TightnessStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Salamh, PT,DPT, Principal investigator, Nova Southeastern University and Southeastern Orthopedics Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810211
- Sponsor's protocol ID
- NovaSEU
- Status last verified
- Mar 2014
- First submitted
- 8 Mar 2013
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population: A Double Blinded Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01810211
- Acronym / sponsor ID
- NovaSEU
- Keywords
- Shoulder, Surgery, Posterior Shoulder Tightness, Flexibility, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Mar 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.
This study will look at which, if any, active stretching procedure is most effective at correcting posterior shoulder tightness (PST) in the post-operative population. Posterior shoulder tightness can influence shoulder mobility and function within both a symptomatic and an asymptomatic population. There are previous studies that have examined the effectiveness of different active stretching procedures and their ability to correct PST but only in the asymptomatic population. As clinicians it will be helpful to investigate their effect within a symptomatic population in order to prescribe appropriate and effective stretches within an individual's home exercise program. The study design is a double blinded randomized control trial. During evaluation a passive measurement of PST and internal rotation will be performed. Another therapist, blinded to the measurements, will randomly select which subgroup the individual will be placed in for the first three individuals and this sequence will be followed for the remainder of the participants. At this time the therapist will instruct the individual on the corresponding exercise which they will perform in front of that therapist. The individual will perform this exercise one more time that day and twice the following day and once again upon follow up prior to having internal rotation and PST measured once again. At this point this will be the conclusion of that individuals involvement in the study.
Null Hypothesis1: Stretches are no more effective than no treatment for reducing PST acutely in the post-operative shoulder population.
Hypothesis1: Stretches are more effective than no treatment for reducing PST acutely in the post-operative population.
Null Hypothesis2: There is no significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.
Hypothesis2: There is a significant difference in the reduction of PST between the horizontal adduction stretch and the modified sleeper stretch acutely in the post-operative shoulder population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Horizontal Adduction Stretch and Pendulums | Experimental | Other: Horizontal Adduction Stretch and PendulumsHorizontal Adduction Stretch- Individual standing with their operative scapula against a wall and rotating toward the side to be stretched to stabilize scapula and the operative arm is relaxed. The opposite hand is placed under the elbow of the involved extremity and assists the operative shoulder into horizontal adduction attempting to bring the hand to the opposite shoulder. Pendulum -Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. |
| Modified Sleeper Stretch and Pendulum | Experimental | Other: Modified Sleeper Stretch and PendulumModified Sleeper Stretch: Individual in supine with operative shoulder abducted to approximately 45 degrees and elbow at 90 degrees of flexion with neutral rotation of the glenohumeral joint. The individual then places other hand on the wrist of the involved extremity and passively moves the glenohumeral joint into internal rotation. Pendulum Exercise: Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. |
| Pendulum Exercise | No intervention | –Pendulum Exercise: Individual leans over with support from uninvolved extremity placed on an immovable object while involved extremity is relaxed. The individual than rotates their hips in order to allow the involved extremity to create small circles passively in a clockwise direction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- arthroscopic shoulder surgery within the past two weeks preceding data collection with
- no surgical complications
- age 18-65.
Key exclusion criteria (8 listed)
- total shoulder arthroplasty
- hemi shoulder arthroplasty
- open rotator cuff repair
- shoulder fracture fixations
- those that are unable to perform interventions and or tolerate measurement positions
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 |
|---|---|---|
| Horizontal Adduction Stretch and Pendulums | Other | Horizontal Adduction Stretch and Pendulums |
| Modified Sleeper Stretch and Pendulum | Other | Modified Sleeper Stretch and Pendulum |
Primary outcome
Inclinometric Measurement of Posterior Shoulder Tightness taken in side-lying
Time frame: Initial evaluation 3 days following surgery and follow up (no longer than 72 hours from initial evaluation)
During the initial evaluation and first follow up, PST of the operative shoulder will be measured in sidelying using an inclinometer that is attached to the mid-humerus of the patient's involved upper extremity using a Velcro strap. An inclinometer is a small device that is used to measure degrees of motion.
1 secondary outcome
Global Rating of Change Score (GROC)
Time frame: At first follow up visit no more than a week after surgery
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 26 Sep 2014.
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.
Paul A Salamh, PT,DPT principal investigator
Nova Southeastern University and Southeastern Orthopedics Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal Adduction Stretch and Pendulums and Modified Sleeper Stretch and Pendulum in people with Postoperative Posterior Shoulder Tightness, run by Nova Southeastern 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 3 inclusion and 8 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 26 Sep 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 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?
Inclinometric Measurement of Posterior Shoulder Tightness taken in side-lying (time frame: Initial evaluation 3 days following surgery and follow up (no longer than 72 hours from initial evaluation)). 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 26 Sep 2014.