Shoulder PainNCT02491489
Activity of the Rotator Cuff During Glenohumeral Mobilization
A study testing Glenohumeral mobilization in people with Shoulder Pain, run by Texas Woman's University.
Trial summary
Shoulder pain is one of the most common musculoskeletal conditions treated by physical therapists. One common treatment is passive glenohumeral joint accessory mobilization, which is the application of a therapist generated force to move the humeral head (ball) on the glenoid (socket) of the shoulder to improve motion… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Glenohumeral mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2015
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals and subjects with shoulder pain
- ages 18-64
- all subjects must be ambulatory, able to transfer onto a standard treatment plinth, and able to tolerate lying supine (on their back) for a minimum of 15 minutes.
Who cannot join
- recent (6 months) shoulder surgery
- shoulder replacement on the involved side
- any history of shoulder fractures
- active cancer or metastatic disease
- coagulation disorders
- current pregnancy
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- rheumatoid arthritis
- active litigation for current injury
- active workman's compensation for current injury
- osteoporosis
About this study
Official title: A Comparison of the Effects of Glenohumeral Mobilization on Rotator Cuff Activity in Normal and Painful Shoulders
Shoulder pain is one of the most common musculoskeletal conditions treated by physical therapists. One common treatment is passive glenohumeral joint accessory mobilization, which is the application of a therapist generated force to move the humeral head (ball) on the glenoid (socket) of the shoulder to improve motion and decrease pain. It is generally accepted that these mobilizations do not elicit active muscular contractions of the surrounding musculature. However, there is very little literature to support this assumption, and a preliminary PubMed search utilizing the terms "shoulder"," mobilization", and "EMG" returned zero relevant references. Therefore, the investigators plan to utilize surface electromyography (EMG), a non-invasive assessment tool, to objectively measure the activity of the rotator cuff muscles (the muscles that surround the shoulder and provide stability to the joint) during various grades(levels of force and amplitude of movement) of glenohumeral mobilization ( a standard of care treatment). It is also unknown if subjects pain levels impact the level of rotator cuff activity. To investigate these questions, the investigators will collect EMG data while performing mobilizations on a total of 20 subjects, divided into two groups: 10 pain free shoulders and 10 painful shoulders. Data analysis will then include descriptive analysis, estimates of effect size, and analysis for between group differences.
The investigators hypothesize that there will be significant differences in muscular activity between groups related to the presence of shoulder pain.
Read the detailed description
Following informed consent, all participants will be assessed in a private EMG lab setting. After exposing the posterior shoulder girdle, the areas of the upper trapezius, supraspinatus, and infraspinatus will be cleaned using a cloth alcohol prep pad, and the skin at the area of electrode placement will be vigorously abraded for 5 seconds. A previously calibrated (per Delsys system protocol) Delsys mini-wireless electrode will then be placed at the appropriate location over each muscle as described by Criswell. These electrodes will be securely taped in place using specialized tape as specified by the manufacturer.
Once electrode placement is complete, each participant will first undergo a standardizing reference contraction of each muscle group. For the upper trapezius, this will consist of 1) a 9 second shrug,2) 9 second elevation of the arm to 90 degrees in the empty can position, and 3) a side lying external rotation of the shoulder to 90 degrees. The middle 3 seconds of each trial will be used to record the average electrical activity of each muscle during voluntary contraction.
Participants will then be placed supine on a standard plinth. The investigators will then proceed to provide a mobilizing force to the subject's glenohumeral joints. Each of two investigators will, in sequence perform a 15 second longitudinal distraction, followed by a 15 second posteriorly directed glenohumeral glide with the shoulder placed in the open pack resting position (~50 degrees abduction, slight horizontal adduction, external rotation). The middle 5 seconds will be captured for mean electrical activity at each of the three previously identified muscles. Following completion of the mobilizations by the second investigator, the electrodes will be removed, and the subject's participation will be complete.
Data analysis will include basic subject demographics such as age, gender, and handedness. Tests of between group difference will be analyzed for each mobilization and tester condition. Data will be analyzed comparing mean EMG values during mobilization compared to the active contraction using the reference voluntary contraction (RVC) method, as this has been shown be a more accurate comparator for low levels of muscle activity.
- Conditions
- Shoulder Pain
- Being tested
- Glenohumeral mobilization
- Keywords
- Manual therapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenohumeral mobilizationOther
Participants will then be placed supine on a standard plinth. The investigators will then proceed to provide a mobilizing force to the participant's glenohumeral joints. Each of two investigators will, in sequence perform a 15 second longitudinal distraction, followed by a 15 second posteriorly directed glenohumeral glide with the shoulder placed in the open pack resting position (~50 degrees abduction, slight horizontal adduction, external rotation).
| Study group | Role | What they receive |
|---|---|---|
| Painful shoulders | Experimental | Subjects with shoulder pain undergoing glenohumeral mobilization Receives: Other: Glenohumeral mobilization |
| Normal shoulders | Active comparator | Subjects without shoulder pain undergoing glenohumeral mobilization Receives: Other: Glenohumeral mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG activity of the rotator cuff using % reference voluntary contraction method
EMG activity collected during the intervention will be compared to the baseline reference contractions.
Measured: EMG data will be collected simultaneously during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491489
- Sponsor's protocol ID
- RCEMG
- Status last verified
- Jun 2015
- First submitted
- 29 Jun 2015
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Glenohumeral Mobilization on Rotator Cuff Activity in Normal and Painful Shoulders
- ClinicalTrials.gov ID
- NCT02491489
- Acronym / sponsor ID
- RCEMG
- Conditions
- Shoulder Pain
- Keywords
- Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Jul 2015 (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.
Shoulder pain is one of the most common musculoskeletal conditions treated by physical therapists. One common treatment is passive glenohumeral joint accessory mobilization, which is the application of a therapist generated force to move the humeral head (ball) on the glenoid (socket) of the shoulder to improve motion and decrease pain. It is generally accepted that these mobilizations do not elicit active muscular contractions of the surrounding musculature. However, there is very little literature to support this assumption, and a preliminary PubMed search utilizing the terms "shoulder"," mobilization", and "EMG" returned zero relevant references. Therefore, the investigators plan to utilize surface electromyography (EMG), a non-invasive assessment tool, to objectively measure the activity of the rotator cuff muscles (the muscles that surround the shoulder and provide stability to the joint) during various grades(levels of force and amplitude of movement) of glenohumeral mobilization ( a standard of care treatment). It is also unknown if subjects pain levels impact the level of rotator cuff activity. To investigate these questions, the investigators will collect EMG data while performing mobilizations on a total of 20 subjects, divided into two groups: 10 pain free shoulders and 10 painful shoulders. Data analysis will then include descriptive analysis, estimates of effect size, and analysis for between group differences.
The investigators hypothesize that there will be significant differences in muscular activity between groups related to the presence of shoulder pain.
Detailed description
Following informed consent, all participants will be assessed in a private EMG lab setting. After exposing the posterior shoulder girdle, the areas of the upper trapezius, supraspinatus, and infraspinatus will be cleaned using a cloth alcohol prep pad, and the skin at the area of electrode placement will be vigorously abraded for 5 seconds. A previously calibrated (per Delsys system protocol) Delsys mini-wireless electrode will then be placed at the appropriate location over each muscle as described by Criswell. These electrodes will be securely taped in place using specialized tape as specified by the manufacturer.
Once electrode placement is complete, each participant will first undergo a standardizing reference contraction of each muscle group. For the upper trapezius, this will consist of 1) a 9 second shrug,2) 9 second elevation of the arm to 90 degrees in the empty can position, and 3) a side lying external rotation of the shoulder to 90 degrees. The middle 3 seconds of each trial will be used to record the average electrical activity of each muscle during voluntary contraction.
Participants will then be placed supine on a standard plinth. The investigators will then proceed to provide a mobilizing force to the subject's glenohumeral joints. Each of two investigators will, in sequence perform a 15 second longitudinal distraction, followed by a 15 second posteriorly directed glenohumeral glide with the shoulder placed in the open pack resting position (~50 degrees abduction, slight horizontal adduction, external rotation). The middle 5 seconds will be captured for mean electrical activity at each of the three previously identified muscles. Following completion of the mobilizations by the second investigator, the electrodes will be removed, and the subject's participation will be complete.
Data analysis will include basic subject demographics such as age, gender, and handedness. Tests of between group difference will be analyzed for each mobilization and tester condition. Data will be analyzed comparing mean EMG values during mobilization compared to the active contraction using the reference voluntary contraction (RVC) method, as this has been shown be a more accurate comparator for low levels of muscle activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painful shoulders | Experimental | Other: Glenohumeral mobilizationSubjects with shoulder pain undergoing glenohumeral mobilization |
| Normal shoulders | Active comparator | Other: Glenohumeral mobilizationSubjects without shoulder pain undergoing glenohumeral mobilization |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy individuals and subjects with shoulder pain
- ages 18-64
- all subjects must be ambulatory, able to transfer onto a standard treatment plinth, and able to tolerate lying supine (on their back) for a minimum of 15 minutes.
Key exclusion criteria (10 listed)
- recent (6 months) shoulder surgery
- shoulder replacement on the involved side
- any history of shoulder fractures
- active cancer or metastatic disease
- coagulation disorders
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 mobilizationParticipants will then be placed supine on a standard plinth. The investigators will then proceed to provide a mobilizing force to the participant's glenohumeral joints. Each of two investigators will, in sequence perform a 15 second longitudinal distraction, followed by a 15 second posteriorly directed glenohumeral glide with the shoulder placed in the open pack resting position (~50 degrees abduction, slight horizontal adduction, external rotation). | Other | Normal shoulders, Painful shoulders |
Primary outcome
EMG activity of the rotator cuff using % reference voluntary contraction method
Time frame: EMG data will be collected simultaneously during the intervention
EMG activity collected during the intervention will be compared to the baseline reference contractions.
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 19 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glenohumeral mobilization in people with Shoulder Pain, run by Texas Woman's University.
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 3 inclusion and 10 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 the rotator cuff using % reference voluntary contraction method (time frame: EMG data will be collected simultaneously during the 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 19 Jul 2018.