- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810211
The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Raleigh, North Carolina, United States, 27609
- Southeastern Orthopedics Physical Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- arthroscopic shoulder surgery within the past two weeks preceding data collection with
- no surgical complications
- age 18-65.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Horizontal Adduction Stretch and Pendulums
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. |
|
Experimental: Modified Sleeper Stretch and Pendulum
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. |
|
No Intervention: Pendulum Exercise
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Initial evaluation 3 days following surgery and follow up (no longer than 72 hours from initial evaluation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Rating of Change Score (GROC)
Time Frame: At first follow up visit no more than a week after surgery
|
This outcome measure asks patients to rate the overall condition of their shoulder from the time they began treatment until now.
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At first follow up visit no more than a week after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul A Salamh, PT,DPT, Nova Southeastern University and Southeastern Orthopedics Physical Therapy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NovaSEU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Posterior Shoulder Tightness
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Federal University of Health Science of Porto AlegreActive, not recruitingPosterior Shoulder TightnessBrazil
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Nova Southeastern UniversitySoutheastern Orthopedics Sports Medicine and Shoulder Center; Triangle Volleyball...CompletedPosterior Shoulder TightnessUnited States
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Hacettepe UniversityCompletedPosterior Shoulder TightnessTurkey
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National Yang Ming UniversityRecruitingPosterior Shoulder TightnessTaiwan
-
Peking University Third HospitalNot yet recruitingSuperior Labrum From Anterior to Posterior InjuriesChina
-
Metzger, Charles, M.D.UnknownShoulder Posterior Capsular Contracture
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Wayne State UniversityCompletedFracture of Shoulder and Upper ArmUnited States
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Johnny K. LeeNorthShore University HealthSystemRecruitingTotal Shoulder Arthroplasty | Reverse Total Shoulder ArthroplastyUnited States
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Istanbul UniversityCompleted
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University of UtahEnrolling by invitationScapular Dyskinesis | Posterior Shoulder InstabilityUnited States
Clinical Trials on Horizontal Adduction Stretch and Pendulums
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Nova Southeastern UniversitySoutheastern Orthopedics Sports Medicine and Shoulder Center; Triangle Volleyball...CompletedPosterior Shoulder TightnessUnited States
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University of VirginiaNational Institutes of Health (NIH)Unknown
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Riphah International UniversityRecruitingOverhead Throwing Athletes | Tennis Players, Bowlers, Volleyball PlayersPakistan
-
King Saud UniversityCompletedStiffness of Shoulder, Not Elsewhere ClassifiedSaudi Arabia
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Qilu Hospital of Shandong UniversityUnknownCatheterization, Peripheral | Catheterization, Central VenousChina
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CEU San Pablo UniversityCompleted
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Dublin City UniversityNot yet recruitingAdductor StrainIreland
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Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
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Riphah International UniversityCompletedCarpal Tunnel SyndromePakistan