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Completed

NCT Number: NCT02491489

Activity of the Rotator Cuff During Glenohumeral Mobilization

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glenohumeral mobilization

Other

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

A Comparison of the Effects of Glenohumeral Mobilization on Rotator Cuff Activity in Normal and Painful Shoulders

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2015
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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