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CompletedNCT02491489Updated Jul 19, 2018

Activity of the Rotator Cuff During Glenohumeral Mobilization

An interventional study of Glenohumeral mobilization in Shoulder Pain, sponsored by Texas Woman's University. Completed. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by Texas Woman's University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Shoulder Pain

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Keywords

  • Manual therapy
03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Texas Woman's University is the lead sponsor of 82 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Painful shoulders

    Subjects with shoulder pain undergoing glenohumeral mobilization

    Other: Glenohumeral mobilization

  • Active comparator
    Normal shoulders

    Subjects without shoulder pain undergoing glenohumeral mobilization

    Other: Glenohumeral mobilization

Interventions

  • OtherGlenohumeral mobilization

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: EMG data will be collected simultaneously during the intervention

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02491489
Lead sponsor
Texas Woman's University
Responsible party
Sponsor
First posted
Jul 8, 2015
Start date
Mar 2015
Primary completion
May 2015
Completion
May 2015
Last update
Jul 19, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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