NCT02164305

Brief Summary

Dynamic control of the rotator cuff muscles plays an important role in stabilizing the shoulder during motion. Impairment in the neuromuscular control of these muscles may to lead to injury and pain. Rehabilitation programs have moderate success in decreasing pain and improving shoulder function. While most of these programs target the rotator cuff, it is still unknown if they serve to improve the neuromuscular control of the rotator cuff muscles. The rehabilitation may induce neurological and physiologic changes in neuromuscular structures and thus alter the neuromuscular control of the entire shoulder complex. Kinematics and electromyographic (EMG) activities have been widely used to study neuromuscular control. However, corticospinal excitability, which has been widely examined in the patients with neurological disorders, provides a more detailed account of central control from the primary motor cortex through the spinal cord to the muscles. This assessment of neuromuscular control will serve to illuminate the ability of the shoulder muscles to handle the stress from activities such as overhead sports activities and carrying or lifting heavy objects. This approach could be used to help design efficient training program for athletes and effective rehabilitation program for patients with shoulder injuries. The purpose of the proposed study is to investigate the effect of exercise treatment effect on the proprioception, kinematics, EMG and corticospinal excitability of shoulder muscles, including the deltoid and rotator cuff muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

May 21, 2014

Last Update Submit

September 12, 2017

Conditions

Keywords

Rotator cuff muscleExcitabilityProprioceptionKinematicsMuscle activityElectromyography

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in muscle activity of rotator cuff and scapular muscles at 4 weeks

    Baseline and 4 weeks

Secondary Outcomes (3)

  • Change from baseline in elevation force at 4 weeks

    Baseline and 4 weeks

  • Change from baseline in proprioception errors at 4 weeks

    Baseline and 4 weeks

  • Change from baseline in the amplitude of motor evoked potential of rotator cuff at 4 weeks

    Baseline and 4 weeks

Study Arms (3)

Strengthening group

EXPERIMENTAL

4-week exercise training, 3 times a week, 30 minutes per visit.

Other: Strengthening group

Neuromuscular group

EXPERIMENTAL

4-week exercise training, 3 times a week, 30 minutes per visit

Other: Neuromuscular group

Control

SHAM COMPARATOR

Only have 2 assessments.

Other: Control

Interventions

Open-chain exercise for rotator cuff and scapular muscles

Strengthening group

Closed-chain exercise for shoulder muscles

Neuromuscular group
ControlOTHER

No exercise training

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Less than 135 degrees of active humeral elevation in the scapular plane
  • Prior shoulder and cervical surgery
  • Presence of shoulder and neck pain
  • Had history of head, cervical or shoulder pain or pathology
  • Stroke and neurological impairment
  • History of seizures
  • Taking anti-seizure and anti-depressive medication
  • With pacemaker and other magnetic implant
  • Pregnancy
  • Athletes performing upper extremity exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Andrew Karduna, PhD

    Department of Human Physiology at University of Oregon

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 21, 2014

First Posted

June 16, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations