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Activity of the Rotator Cuff During Glenohumeral Mobilization

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Glenohumeral mobilization
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Manual therapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • rheumatoid arthritis
  • active litigation for current injury
  • active workman's compensation for current injury
  • osteoporosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Painful shoulders

    Normal shoulders

    Arm Description

    Subjects with shoulder pain undergoing glenohumeral mobilization

    Subjects without shoulder pain undergoing glenohumeral mobilization

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    July 18, 2018
    Sponsor
    Texas Woman's University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02491489
    Brief Title
    Activity of the Rotator Cuff During Glenohumeral Mobilization
    Official Title
    A Comparison of the Effects of Glenohumeral Mobilization on Rotator Cuff Activity in Normal and Painful Shoulders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Woman's University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    Manual therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Painful shoulders
    Arm Type
    Experimental
    Arm Description
    Subjects with shoulder pain undergoing glenohumeral mobilization
    Arm Title
    Normal shoulders
    Arm Type
    Active Comparator
    Arm Description
    Subjects without shoulder pain undergoing glenohumeral mobilization
    Intervention Type
    Other
    Intervention Name(s)
    Glenohumeral mobilization
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    EMG activity of the rotator cuff using % reference voluntary contraction method
    Description
    EMG activity collected during the intervention will be compared to the baseline reference contractions.
    Time Frame
    EMG data will be collected simultaneously during the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 rheumatoid arthritis active litigation for current injury active workman's compensation for current injury osteoporosis

    12. IPD Sharing Statement

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    Activity of the Rotator Cuff During Glenohumeral Mobilization

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