Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04513535 |
Other study ID # |
PRO20010001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 7, 2020 |
Est. completion date |
November 1, 2020 |
Study information
Verified date |
February 2021 |
Source |
University of Hartford |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to directly compare the effects of four distinct interventions
commonly used in the treatment of shoulder pathology on shoulder range of motion (ROM) and
strength in asymptomatic shoulders:
- grade III oscillatory anterior-posterior glenohumeral joint mobilizations
- an internal rotation (IR) "sleeper" stretch
- supine upper-thoracic manipulation
- cervical spine manipulation
Description:
Research questions:
Do different interventions result in different immediate changes in shoulder ROM? Ha1:
Stretching and glenohumeral mobilization will result in increased shoulder ROM Ha2: Thoracic
and Cervical manipulations will result in decreased shoulder ROM Ho: There will be no
differences in shoulder ROM between groups for each of the four interventions
Do different interventions result in different immediate effects for shoulder external
rotation (ER) strength? Ha1: Stretching and glenohumeral mobilization will result in a
decrease in ER strength Ha2: Thoracic and cervical manipulations will result in increased ER
strength Ho: There will be no differences in ER strength between groups for each of the four
interventions
Do different interventions result in different immediate effects for shoulder
electromyographic (EMG) activity? Ha1: Stretching and glenohumeral mobilization will result
in a decrease in EMG activity Ha2: Thoracic and cervical manipulations will result in
increased EMG activity Ho: There will be no differences EMG activity between groups for each
of the four interventions
Based on pilot data, the apparent effect sizes ranged from .57 - .78. With the ɑ = .05 and
1-β = .80, G-power software for a 4 group ANOVA yields a sample of 20 participants per group.
To account for possible sample variations and participant drop-outs, a sample of 24 per group
will be enrolled. Based on the study design of a randomized cross-over study, where each
participant will receive two of the interventions, a total sample of 48 individuals will be
enrolled.
Once a participant is cleared to participate, all individuals will undergo the following
tests:
External Rotator Strength Test Strength of the external rotators (infraspinatus) will be
measured by a blinded examiner using a hand-held dynamometer (Micro-FET 2, Hoggan Health
Industries, Salt Lake CIty, UT). The dynamometer will be placed on the high threshold setting
and the force recorded in Newtons. The strength measurement will be taken with the
participant in the prone position with their shoulder abducted 90 degrees and 80 degrees of
external rotation with the elbow bent to 90 degrees. Abduction (ABD) and elbow flexion ROM
positioning will be assessed using a goniometer, and the shoulder external rotation ROM will
be measured using the iPhoneX. To ensure consistent placement, the researchers will place a
mark 10 cm proximal to the medial epicondyle of the humerus. This mark will be aligned with
the edge of the table in order to allow for adequate clearing of the arm and dynamometer
while completing the test. A second mark will be placed on the distal end of the radius,
using the radial styloid process as a reference. The distal edge of the dynamometer will be
placed at this mark. The testers knee will be positioned behind the participant's elbow to
ensure there is no compensation and activation of other muscles. At the start of the test the
participant will be instructed to resist the pressure applied by the tester. The tester will
apply their force progressively over 5 seconds while the participant maximally resists
against the dynamometer plate. Two pretest and two post-test measurements of strength will be
obtained, with the greater measurement used for data analysis.
Posterior Shoulder Tightness Posterior shoulder tightness (PST) will be measured by blinded
examiners with the participant side lying with hips and knees flexed to 45 degrees. The
non-tested humerus will be placed behind the participants head with half of their humerus off
of the plinth. The participants' arm being tested will be placed so that the humeral condyles
will be stacked perpendicular to the plinth with the olecranon facing posteriorly in relation
to the participants' body. The participant's arm will be marked 5cm proximal to the lateral
epicondyle, where an independent examiner will place the top of the iPhoneX to measure PST in
degrees. The Level in the Measure application, manufactured by Apple's arkit via iOS 13.2.3,
will be used to measure horizontal adduction and quantify PST. The tester will be blinded
from the results of the PST measurement. The arm being tested will be gripped by the tester
just distal to the humeral condyles. The scapula will be stabilized in retraction throughout
the test. The test will be completed and the measurement will be recorded when the tester is
no longer able to stabilize the scapula or the movement ceases. Two trials will be performed
by the tester with a 10 second rest between trials.
Internal Rotation ROM Internal rotation range of motion will be measured by a blinded
examiner with the participant in the prone position, shoulder abducted to 90 degrees, with a
bolster under the mid-humerus to keep the glenohumeral joint in the neutral position. A mark
will be placed on the participants arm 5cm distal to the medial epicondyle on the ventral
forearm where the top of the iPhoneX will be placed to measure internal rotation range of
motion in degrees. Two testers will be used to complete the test. One tester will apply
stabilization by placing their elbow atop the scapula, their forearm on top of the
participant's humerus, and take the participants through the motion. The other tester will
hold the iPhoneX and record the final measurement. The test will be completed when the
scapula begins to rise from the table or no further motion is felt. The tester performing the
motion will be blinded to the measurements being taken. Two trials will be taken on the right
upper extremity.
The iPhoneX (iOS 13.2.3) will be used as an inclinometer using the Level in the Measure
application that is pre-downloaded on the iPhoneX. In this study, the smartphone inclinometer
application that is available to iPhones for purchase was used.
EMG of the Infraspinatus Pre-post intervention activity of the infraspinatus muscle will be
assessed with surface EMG during a maximal voluntary isometric contraction (MVIC). Before
placing the electrodes on the participants, the area will be thoroughly cleaned with an
alcohol wipe. A single, Norotrode 20 electrode will then be placed over the muscle belly of
the infraspinatus. The Delsys EMGworks acquisition software will be used to obtain all EMG
data. The electrodes will be sampled at a rate of 1926 samples/s. Maximal Voluntary Isometric
Contraction (MVIC) will be recorded simultaneously with the isometric strength testing. The
MVC for each participant consists of a 5s hold in the standard manual muscle testing(MMT)
positioning.
All EMG data will be prepared and collected by an assessor blinded to the assigned
intervention, and will be analyzed using the Delsys EMGworks Analysis software.
Randomization:
Prior to enrollment, using paired, block randomization, a set of 48 group assignments will be
prepared and placed in sealed, opaque envelopes by an individual not involved in the data
collection process.
The participants will be assigned to two of the four different intervention groups: posterior
shoulder mobilization, cervical manipulation, thoracic manipulation, and a self-applied
sleeper stretch technique.
All participants will select an envelope at the time of enrollment, and only reveal the
contents to the examiner preforming the intervention. The first intervention will be applied
at the first research session, and the second intervention will be applied during a second
session approximately one week later.
Data Analysis:
Baseline and participant demographic data will be analyzed and reported using descriptive and
measures of central tendency.
Interaction and main effects for Internal rotation ROM, posterior shoulder tightness,
external rotation force, and infraspinatus EMG activity x intervention will be assessed with
repeated measures ANOVAs and post hoc testing.