A Comparison of Electromyographic Activity & Glenohumeral Motion
Primary Purpose
Orthopedic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glenohumeral mobilization-oscillation
glenohumeral mobilization-sustained
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Disorder focused on measuring shoulder, mobilization, electromyography, imaging ultrasound
Eligibility Criteria
Inclusion Criteria:
- both healthy volunteers, as well as individuals with shoulder stiffness
Exclusion Criteria:
- shoulder surgery within the past 6 months
- history of shoulder fractures
- rheumatoid arthritis
- osteoporosis
- current pregnancy
- active cancer
- blood clotting or connective tissue disorders
- receiving workman's compensation benefits for your shoulder injury
- pending litigation for your shoulder injury
Sites / Locations
- University of New England
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
control oscillation
control sustained
stiff oscillation
stiff sustained
Arm Description
control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation
control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained
subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation
subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained
Outcomes
Primary Outcome Measures
EMG activity of posterior rotator cuff
Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization
Secondary Outcome Measures
force applied during mobilization
force sensor used to determine force required to produce glenohumeral translation, compared pre-post intervention
translation of humeral head
Real time US imaging to determine amount of translation, assess pre-post intervention changes
pain pressure threshold-bilateral deltoid
pain pressure threshold at deltoid bilaterally; assessed for changes pre-post intervention
pain pressure threshold-bilateral forearm
pain pressure threshold at medial forearmbilaterally; assessed for changes pre-post intervention
Full Information
NCT ID
NCT03001908
First Posted
December 1, 2016
Last Updated
June 4, 2018
Sponsor
University of New England
1. Study Identification
Unique Protocol Identification Number
NCT03001908
Brief Title
A Comparison of Electromyographic Activity & Glenohumeral Motion
Official Title
A Comparison of Electromyographic(EMG) Activity & Glenohumeral Motion During Posterior Glide Mobilizations in Healthy & Stiff Shoulders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New England
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to determine the relationships between motion, pain perception, and mobility in the glenohumeral joint. Muscle activity, joint motion, and pain will be measured pre-post randomized interventions to determine the response to various physical therapy techniques.
Detailed Description
To achieve the study aims, 88 adults (44 controls, 44 with stiff shoulders) between the ages of 18-65 will be recruited. The investigators will apply a protocol based on current evidence for effectiveness of mobilizations (4 bouts of 30 sec, oscillatory gr III mobilization @1 Hz vs. 4 bouts of 30 seconds, static gr III mobilization), with interventions determined by randomized blocked assignment. Before and after the intervention, the investigators will assess levels of EMG activity of the posterior rotator cuff during a posterior glide, the force required for the mobilization to reach end range stretch, the amount of humeral head translation on the glenoid via US, and pain pressure thresholds (PPT). The data collected will allow investigators to determine the mechanisms involved in range of motion (ROM) changes and hypoalgesia produced by glenohumeral (GH) joint mobilization in both normal and stiff shoulders by evaluating the main and interaction effects of: the type of mobilization (static vs oscillatory), the magnitude of joint translation via imaging ultrasound, the EMG response of the supraspinatus and infraspinatus muscles, and changes in local and central pain processing observed via PPT testing. These data will allow investigators to evaluate whether motion improvements occur due to mechanical factors (stretch of the capsule observed via change in translation), neurophysiologic factors (change in translation associated with reduction in EMG activity), or both. Concurrent measurements of pain processing by the nervous system (local and central mechanisms) will allow evaluation of whether changes in pain processing occur following oscillatory movements, sustained movements, or both. This information will result in improved understanding of the mechanisms of action of joint mobilization, determination of the efficacy of various modes of mobilization to improve joint translation, and determination of the efficacy of various modes of mobilization to decrease pain.
Data analysis:
All data will be analyzed in aggregate form using quantitative statistics. Descriptive statistics will be utilized for demographic data including age, height, weight, gender, handedness, and side of intervention.
Groups will be measured using tests of difference based on group assignments (normal vs stiff shoulder; sustained vs oscillatory mobilization) comparing peak and root mean squared EMG activity, pain pressure thresholds, force of mobilization, and amount of translation measured via US as well as analysis of interaction effects.
All data will be analyzed using an intention to treat model, and any missing data points were replaced using imputation via means of the group.
All outliers, defined as data points beyond the 95th percentile and identified as outliers during analysis in SPSS, will be Winsorized to minimize the effect of potentially spurious outliers via replacement with the highest non-outlier obtained value for the group.
Descriptive statistics including means, ranges and standard deviations will be assessed for each group condition.
Data will be assessed for the required assumptions for parametric testing/ Analysis of variance(ANOVA) including Mauchly's test of sphericity and the Shapiro-Wilk test of normality. Data not meeting the required assumptions will be assessed with the appropriate non-parametric equivalent test.
Aim 1 will investigate the relationships and within and between group differences in rotator cuff activity (EMG) and posterior glide mobility and mobilization force in the glenohumeral joint in individuals with stiff and normal shoulders based on joint mobilization type.
To analyze within subjects main effects, interaction effects, and second order interaction effects of group and mobilization condition on the DV, three-way between-between-within mixed ANOVAs will be used.
IV: shoulder condition stiff vs normal; oscillation vs static posterior glide; time.
X Repeated measure Dependent variables(DV)s: EMG, US translation, force In the presence of significant three way interactions, post hoc testing to determine simple two way interaction effects will be performed using separate two way ANOVAs Univariate testing will be utilized to determine the presence of simple main effects.
Post hoc analysis will utilize pairwise comparisons in the presence of significant main effects. Bonferroni correction will be utilized due to multiple tests, with comparisons within each simple-simple main effect considered a family of comparisons.
To investigate the relationships between rotator cuff activity (EMG) and posterior glide mobility in individuals with stiff and normal shoulders, point bi-serial correlation will be utilized to assess for meaningful relationships between the following variables:
Mobilization condition x change in EMG, US, force Group (stiff vs control) assignment x change in EMG, US, force Aim 2 will investigate the within and between group differences and relationships between changes in PPT and type of mobilization (static, oscillatory) in individuals with stiff and normal shoulders.
Between group differences will be assessed via ind. t-tests, using the dichotomous independent variables (IV) static vs. oscillatory mobilization, and the DV of PPT measures.
Within group differences will be assessed via paired t-tests, using the dichotomous IV static vs. oscillatory mobilization, and the DV of PPT measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
shoulder, mobilization, electromyography, imaging ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control oscillation
Arm Type
Active Comparator
Arm Description
control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation
Arm Title
control sustained
Arm Type
Active Comparator
Arm Description
control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained
Arm Title
stiff oscillation
Arm Type
Experimental
Arm Description
subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation
Arm Title
stiff sustained
Arm Type
Experimental
Arm Description
subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained
Intervention Type
Other
Intervention Name(s)
glenohumeral mobilization-oscillation
Other Intervention Name(s)
musculoskeletal manipulation
Intervention Description
posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds
Intervention Type
Other
Intervention Name(s)
glenohumeral mobilization-sustained
Other Intervention Name(s)
musculoskeletal manipulation
Intervention Description
posterior glide mobilization, sustained 4 x 30 seconds
Primary Outcome Measure Information:
Title
EMG activity of posterior rotator cuff
Description
Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization
Time Frame
Immediate post-intervention
Secondary Outcome Measure Information:
Title
force applied during mobilization
Description
force sensor used to determine force required to produce glenohumeral translation, compared pre-post intervention
Time Frame
baseline, immediately post intervention (within 3 minutes)
Title
translation of humeral head
Description
Real time US imaging to determine amount of translation, assess pre-post intervention changes
Time Frame
baseline, immediately post intervention (within 3 minutes)
Title
pain pressure threshold-bilateral deltoid
Description
pain pressure threshold at deltoid bilaterally; assessed for changes pre-post intervention
Time Frame
baseline, immediately post intervention (within 5 minutes)
Title
pain pressure threshold-bilateral forearm
Description
pain pressure threshold at medial forearmbilaterally; assessed for changes pre-post intervention
Time Frame
baseline, immediately post intervention (within 5 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
both healthy volunteers, as well as individuals with shoulder stiffness
Exclusion Criteria:
shoulder surgery within the past 6 months
history of shoulder fractures
rheumatoid arthritis
osteoporosis
current pregnancy
active cancer
blood clotting or connective tissue disorders
receiving workman's compensation benefits for your shoulder injury
pending litigation for your shoulder injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian T Swanson, PT, DSc
Organizational Affiliation
University of New England
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New England
City
Portland
State/Province
Maine
ZIP/Postal Code
04103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of Electromyographic Activity & Glenohumeral Motion
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