NCT04493190

Brief Summary

Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been accounted for 44-65 % of all shoulder pain. It is believed that one important contributing factor is scapular dyskinesis. Patients with SIS demonstrates scapular dyskinesis, including decrease in upward rotation, scapular posterior tilt, and external rotation. Altered muscle activity of scapular muscles may contribute to scapular dyskinesis, such as increase in activity of upper trapezius, and decrease in activity of lower trapezius and serratus anterior. In addition to these changes in neuromuscular control, central nervous system may be re-organized in patients with musculoskeletal disorders. Evidence has been reported that center of gravity of motor mapping changes, corticospinal excitability decreases and inhibition increases in patients with shoulder injuries such as instability, rotator cuff tendinopathy and SIS. These corticospinal changes are believed to be related to chronicity of symptoms and lack of treatment effects. Previous studies have applied many types of treatments to SIS, such as manipulation, taping, and exercises. However, most studies mainly focused on the outcomes of pain and function, few studies investigated changes in neuromuscular control following treatments. Yet, no study has addressed how corticospinal system changes following treatment in patient with shoulder injuries. Motor skill training, which has been widely used in training healthy subjects or patients with neurological disorders, has been shown to change corticospinal systems, including increasing excitability and decreasing inhibition. To our knowledge, no study has integrated the concepts of motor skill learning into a short-term treatment or investigated the effects of motor skill training on corticospinal systems in patients with SIS. The purposes of the study are to investigate the effects of short-term motor skill training on pain, neuromuscular control, corticospinal system in patients with SIS, and also to investigate whether changes in corticospinal parameters will be related to changes in pain, function and neuromuscular control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

June 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2021

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

June 29, 2020

Last Update Submit

April 5, 2022

Conditions

Keywords

Corticospinal excitabilityTranscranial magnetic stimulationMotor control trainingScapula-focused exercise

Outcome Measures

Primary Outcomes (8)

  • Change in neurophysiological measures - Active motor threshold

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

    Change from baseline AMT at 6 weeks

  • Change in neurophysiological measures - Motor evoked potential

    Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity

    Change from baseline MEP at 6 weeks

  • Change in neurophysiological measures - Cortical silent period

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

    Change from baseline CSP at 6 weeks

  • Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation

    Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses

    Change from baseline SICI and SICF at 6 weeks

  • Change in shoulder pain

    Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.

    Change from baseline pain at 6 weeks

  • Change in shoulder function

    Function will be measured questionnaire, Flexilevel Scale of Shoulder Function (FLEX-SF). There are 15 questions on each difficulty version. Zero indicates the most difficulty, while 3 means the least difficulty.

    Change from baseline function at 6 weeks and 3 months

  • Long-term change in shoulder pain

    Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.

    Change from baseline pain at 3 months

  • Long-term change in shoulder function

    Function will be measured questionnaire, FLEX-SF. There are 15 questions on each

    Change from baseline pain at 3 months

Secondary Outcomes (2)

  • Scapular kinematics

    Change from baseline scapular kinematics at 6 weeks

  • Scapular muscle activation

    Change from baseline muscle activation at 6 weeks

Study Arms (3)

Scapular control training group

EXPERIMENTAL

Participants in these group will be taught how to correctly movement arm overhead. And they will undergo series of movement tasks with mirror and also receive scapular-focused exercises. The difficulty of the movements protocol will increase weekly.

Procedure: Scapular control training

General exercise group

EXPERIMENTAL

Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly.

Procedure: General exercise

Healthy subject group

NO INTERVENTION

No intervention.

Interventions

Participants in this group will learn how to maintain normal scapular position at first. Then they will progress to moving arm with good scapular control with mirror. Afterward, participants will undergo movements protocol which give different directions of arm movements while keeping scapula in a good alignment. They will also receive scapular-focused exercises. The difficulty of the movement protocol will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.

Scapular control training group

Participants in this group will receive a general shoulder strengthening with theraband or dumbbell. Load will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.

General exercise group

Eligibility Criteria

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

You may qualify if:

  • perform overhead exercise at least 4 hours a week
  • present type I or II scapular dyskinesis at rest or moving
  • pain at least two weeks
  • of 6 impingement test present positive
  • Neer's impingement test: arm abduction overhead with shoulder internal rotation and thumb downward. If feel pain, then positive.
  • Hawkins-Kennedy impingement Test: arm lift to horizontal plane, elbow flexion to 90 degree. Tester put force on forearm toward shoulder internal rotation. If feel pain, then positive.
  • Empty can test: shoulder abduction with thumb down, then give a resistive force toward up. If feel pain, then positive.
  • Resistive shoulder external rotation test: elbow flexion to 90 degrees and do resistive shoulder rotation. If feel pain, then positive.
  • Rotator cuff tenderness test: tester put pressure on rotator cuff. If feel pain, then positive.
  • Painful arc: perform arm elevation. If feel pain during movement, then positive.
  • perform overhead exercise at least 4 hours a week
  • no any symptoms or injuries on shoulder and neck

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 transcranial magnetic stimulation (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)

National Yang-Ming University

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 30, 2020

Study Start

November 2, 2020

Primary Completion

August 26, 2021

Study Completion

November 26, 2021

Last Updated

April 6, 2022

Record last verified: 2022-04

Locations