NCT04014491

Brief Summary

Shoulder impingement syndrome is the most common shoulder disorder in overhead athletes. It describes a mechanical compression of subacromial bursa and rotator cuff tendons during arm movement, which results in pain and injuries. Most of previous studies focus on investigating motor performance in individuals with shoulder impingement syndrome and found altered scapular kinematics and muscle activation may contribute to the impingement. Recently few studies found changes in the central nervous system, decreases in corticospinal excitability and increases in inhibition in scapular muscles, by using transcranial magnetic stimulation (TMS). Although more studies are still needed to investigate the changes in central nervous system in the individuals with impingement syndrome, the changes in central nervous system are believed to be associated with the deficits of impingement syndrome. However, the exercise protocols for the impingement syndrome are usually designed to restore scapular kinematics and muscle activation, including scapular muscle strengthening exercise and scapular control exercise. To our knowledge, no study has investigated whether these exercise protocols can reverse these changes in the corticospinal system. The objectives of this proposal are to understand neuromuscular and neurophysiological mechanisms of the scapula-focused exercise protocols to improve the effectiveness of treatment. The study aims to investigate the effects of scapular muscle strengthening training and scapular control training on the scapular kinematics, muscle activation and corticospinal system. The study also aims to investigate whether any other cortical mechanisms are also affected by the shoulder impingement syndrome. We will recruit 70 overhead athletes with shoulder impingement syndrome and 22 healthy control athletes. Subjects with shoulder impingement syndrome will randomly receive either scapular muscle strengthening or scapular control training. When performing the exercise, subjects in the scapular control training group will receive electromyography feedback and cues but those in the strengthening training group will not. Immediate effects of these two training protocols on scapular kinematics, muscle activation, and neurophysiological measures will be tested before and after the training. Neurophysiological measures will be tested by TMS, including corticospinal excitability, cortical inhibition, intracortical inhibition, and intracortical facilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

July 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 22, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

July 1, 2019

Last Update Submit

May 20, 2021

Conditions

Keywords

Shoulder impingement syndromeTranscranial magnetic stimulationCorticospinal systemScapular control exerciseKinematics

Outcome Measures

Primary Outcomes (5)

  • Neurophysiological measures - Active motor threshold

    Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).

    Immediately after the intervention

  • Neurophysiological measures - Motor evoked potential

    Motor evoked potential (MEP) will be described with millivolt (mV).

    Immediately after the intervention

  • Neurophysiological measures - Cortical silent period

    Cortical silent period (CSP) will be measured with millisecond (ms).

    Immediately after the intervention

  • Neurophysiological measures - Short interval cortical inhibition

    Short interval cortical inhibition (SICI) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is below 5 ms

    Immediately after the intervention

  • Neurophysiological measures - Intra-cortical facilitation

    Intra-cortical facilitation (ICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms

    Immediately after the intervention

Secondary Outcomes (2)

  • Scapular kinematics

    Immediately after the intervention

  • Scapular muscles activation

    Immediately after the intervention

Study Arms (3)

Scapula control exercise

EXPERIMENTAL

Subjects will perform three exercises with EMG biofeedback and verbal cues. Three exercises are elevation in scapular plane, sidelying external rotation and dynamic hug plus

Procedure: Scapula control exercise

Scapula strengthening exercise

EXPERIMENTAL

The subjects in the scapular strengthening group will be asked to perform the three exercises the same as scapula control exercise group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction.

Procedure: scapular strengthening exercise

Healthy subject group

OTHER

Healthy subjects will be included to compare the differences in corticospinal system between healthy subjects and subjects with shoulder impingement syndrome, so this group will not receive any treatment.

Other: No intervention

Interventions

To perform arm elevation in the scapular plane, subjects will be first asked to correct scapular resting posture in sitting with EMG biofeedback. Then the subjects will be instructed to do elevation in the scapular plane, side lying external rotation and dynamic hug plus with control of the scapula by EMG feedback and verbal cues

Scapula control exercise

The subjects in the scapular strengthening group will be asked to perform these three exercises the same as scapula control group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction.

Scapula strengthening exercise

No intervention

Healthy subject group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Practice overhead exercise more than six hours a week,
  • Aged 20 to 40 years old,
  • Have shoulder pain localized at the anterior or lateral aspect of shoulder more than two weeks,
  • Have obvious medial border prominence of the scapula at 90° of arm elevation,
  • Have shoulder impingement syndrome, which is confirmed by having at least two of the following: (a) positive Neer test, (b) positive Hawkins sign, (c) positive empty can test, (d) positive resisted external rotation test, and (e) tenderness of the rotator cuff tendons
  • Practice overhead exercise more than six hours a week,
  • Aged 20 to 40 years old,
  • Not have a history of shoulder or neck pain or injury.

You may not qualify if:

  • Have a history of dislocation, fracture, or surgery of upper extremity,
  • A history of direct contact injury to the neck or upper extremities within the past 12 months,
  • A concussion within the past 12 months or a history of three or more concussions,
  • Brain injury and neurological impairment,
  • History of frequent headache or dizziness,
  • Contraindications to the use of TMS, assessed with a safety screening questionnaire, including pregnancy, history of seizure, epilepsy and syncope, having cochlear implant, having medal implant and taking anti-depressant medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yin-Liang Lin

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Yin-Liang Lin, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

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

July 1, 2019

First Posted

July 10, 2019

Study Start

October 22, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations