NCT03001908

Brief Summary

Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to determine the relationships between motion, pain perception, and mobility in the glenohumeral joint. Muscle activity, joint motion, and pain will be measured pre-post randomized interventions to determine the response to various physical therapy techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

December 1, 2016

Last Update Submit

June 4, 2018

Conditions

Keywords

shouldermobilizationelectromyographyimaging ultrasound

Outcome Measures

Primary Outcomes (1)

  • EMG activity of posterior rotator cuff

    Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization

    Immediate post-intervention

Secondary Outcomes (4)

  • force applied during mobilization

    baseline, immediately post intervention (within 3 minutes)

  • translation of humeral head

    baseline, immediately post intervention (within 3 minutes)

  • pain pressure threshold-bilateral deltoid

    baseline, immediately post intervention (within 5 minutes)

  • pain pressure threshold-bilateral forearm

    baseline, immediately post intervention (within 5 minutes)

Study Arms (4)

control oscillation

ACTIVE COMPARATOR

control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation

Other: glenohumeral mobilization-oscillation

control sustained

ACTIVE COMPARATOR

control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained

Other: glenohumeral mobilization-sustained

stiff oscillation

EXPERIMENTAL

subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation

Other: glenohumeral mobilization-oscillation

stiff sustained

EXPERIMENTAL

subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained

Other: glenohumeral mobilization-sustained

Interventions

posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds

Also known as: musculoskeletal manipulation
control oscillationstiff oscillation

posterior glide mobilization, sustained 4 x 30 seconds

Also known as: musculoskeletal manipulation
control sustainedstiff sustained

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • both healthy volunteers, as well as individuals with shoulder stiffness

You may not qualify if:

  • shoulder surgery within the past 6 months
  • history of shoulder fractures
  • rheumatoid arthritis
  • osteoporosis
  • current pregnancy
  • active cancer
  • blood clotting or connective tissue disorders
  • receiving workman's compensation benefits for your shoulder injury
  • pending litigation for your shoulder injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New England

Portland, Maine, 04103, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Brian T Swanson, PT, DSc

    University of New England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 23, 2016

Study Start

December 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations