Orthopedic DisorderNCT03001908
A Comparison of Electromyographic Activity & Glenohumeral Motion
A study testing glenohumeral mobilization-oscillation and glenohumeral mobilization-sustained in people with Orthopedic Disorder, run by University of New England at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- glenohumeral mobilization-oscillation and glenohumeral mobilization-sustained
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 30 Apr 2018
- 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
- both healthy volunteers, as well as individuals with shoulder stiffness
Who cannot join
- shoulder surgery within the past 6 months
- history of shoulder fractures
- rheumatoid arthritis
- osteoporosis
- current pregnancy
- active cancer
Show all 9Show fewer
- blood clotting or connective tissue disorders
- receiving workman's compensation benefits for your shoulder injury
- pending litigation for your shoulder injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Electromyographic(EMG) Activity & Glenohumeral Motion During Posterior Glide Mobilizations in Healthy & Stiff Shoulders
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.
Read the 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.
- Conditions
- Orthopedic Disorder
- Being tested
- glenohumeral mobilization-oscillation, glenohumeral mobilization-sustained
- Keywords
- shoulder, mobilization, electromyography, imaging ultrasound
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glenohumeral mobilization-oscillationOther
Also called musculoskeletal manipulation
posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds
glenohumeral mobilization-sustainedOther
Also called musculoskeletal manipulation
posterior glide mobilization, sustained 4 x 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| control oscillation | Active comparator | control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation Receives: Other: glenohumeral mobilization-oscillation |
| control sustained | Active comparator | control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained Receives: Other: glenohumeral mobilization-sustained |
| stiff oscillation | Experimental | subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation Receives: Other: glenohumeral mobilization-oscillation |
| stiff sustained | Experimental | subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained Receives: Other: glenohumeral mobilization-sustained |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activity of posterior rotator cuff
Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization
Measured: Immediate post-intervention
Secondary outcomes (4)
force applied during mobilization
force sensor used to determine force required to produce glenohumeral translation, compared pre-post intervention
Measured: baseline, immediately post intervention (within 3 minutes)
translation of humeral head
Real time US imaging to determine amount of translation, assess pre-post intervention changes
Measured: baseline, immediately post intervention (within 3 minutes)
pain pressure threshold-bilateral deltoid
pain pressure threshold at deltoid bilaterally; assessed for changes pre-post intervention
Measured: baseline, immediately post intervention (within 5 minutes)
pain pressure threshold-bilateral forearm
pain pressure threshold at medial forearmbilaterally; assessed for changes pre-post intervention
Measured: baseline, immediately post intervention (within 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian T Swanson, University of New England
- Investigators
- Brian T Swanson, PT, DSc, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001908
- Sponsor's protocol ID
- UNE 052316-013
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Electromyographic(EMG) Activity & Glenohumeral Motion During Posterior Glide Mobilizations in Healthy & Stiff Shoulders
- ClinicalTrials.gov ID
- NCT03001908
- Acronym / sponsor ID
- UNE 052316-013
- Conditions
- Orthopedic Disorder
- Keywords
- shoulder, mobilization, electromyography, imaging ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 23 Dec 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control oscillation | Active comparator | Other: glenohumeral mobilization-oscillationcontrol subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation |
| control sustained | Active comparator | Other: glenohumeral mobilization-sustainedcontrol subjects with normal shoulders will undergo the glenohumeral mobilization-sustained |
| stiff oscillation | Experimental | Other: glenohumeral mobilization-oscillationsubjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation |
| stiff sustained | Experimental | Other: glenohumeral mobilization-sustainedsubjects with stiff shoulders will undergo the glenohumeral mobilization-sustained |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- both healthy volunteers, as well as individuals with shoulder stiffness
Key exclusion criteria (9 listed)
- shoulder surgery within the past 6 months
- history of shoulder fractures
- rheumatoid arthritis
- osteoporosis
- current pregnancy
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 |
|---|---|---|
| glenohumeral mobilization-oscillationAlso: musculoskeletal manipulationposterior glide mobilizations oscillated at 1hz, 4 x 30 seconds | Other | control oscillation, stiff oscillation |
| glenohumeral mobilization-sustainedAlso: musculoskeletal manipulationposterior glide mobilization, sustained 4 x 30 seconds | Other | control sustained, stiff sustained |
Primary outcome
EMG activity of posterior rotator cuff
Time frame: Immediate post-intervention
Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization
4 secondary outcomes
force applied during mobilization
Time frame: baseline, immediately post intervention (within 3 minutes)
translation of humeral head
Time frame: baseline, immediately post intervention (within 3 minutes)
pain pressure threshold-bilateral deltoid
Time frame: baseline, immediately post intervention (within 5 minutes)
pain pressure threshold-bilateral forearm
Time frame: baseline, immediately post intervention (within 5 minutes)
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 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Brian T Swanson, PT, DSc principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glenohumeral mobilization-oscillation and glenohumeral mobilization-sustained in people with Orthopedic Disorder, run by University of New England 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 1 inclusion and 9 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 6 Jun 2018. 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?
EMG activity of posterior rotator cuff (time frame: Immediate post-intervention). 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 6 Jun 2018.