NCT02491489

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
Last Updated

July 19, 2018

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

June 29, 2015

Last Update Submit

July 18, 2018

Conditions

Keywords

Manual therapy

Outcome Measures

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.

    EMG data will be collected simultaneously during the intervention

Study Arms (2)

Painful shoulders

EXPERIMENTAL

Subjects with shoulder pain undergoing glenohumeral mobilization

Other: Glenohumeral mobilization

Normal shoulders

ACTIVE COMPARATOR

Subjects without shoulder pain undergoing glenohumeral mobilization

Other: Glenohumeral mobilization

Interventions

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).

Normal shouldersPainful shoulders

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 8, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 19, 2018

Record last verified: 2015-06