The Most Effective Intervention for Reducing Posterior Shoulder Tightness Acutely in the Post-operative Population

September 24, 2014 updated by: Nova Southeastern University

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

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Southeastern Orthopedics Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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)
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.
Initial evaluation 3 days following surgery and follow up (no longer than 72 hours from initial evaluation)

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.
At first follow up visit no more than a week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul A Salamh, PT,DPT, Nova Southeastern University and Southeastern Orthopedics Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

March 1, 2014

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.

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