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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04014491
Other study ID # YM108043F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2019
Est. completion date February 28, 2021

Study information

Verified date May 2021
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: (patients of shoulder impingement) 1. Practice overhead exercise more than six hours a week, 2. Aged 20 to 40 years old, 3. Have shoulder pain localized at the anterior or lateral aspect of shoulder more than two weeks, 4. Have obvious medial border prominence of the scapula at 90° of arm elevation, 5. 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 Inclusion Criteria: (healthy subjects) 1. Practice overhead exercise more than six hours a week, 2. Aged 20 to 40 years old, 3. Not have a history of shoulder or neck pain or injury. Exclusion Criteria (patients of shoulder impingement and healthy subjects) 1. Have a history of dislocation, fracture, or surgery of upper extremity, 2. A history of direct contact injury to the neck or upper extremities within the past 12 months, 3. A concussion within the past 12 months or a history of three or more concussions, 4. Brain injury and neurological impairment, 5. History of frequent headache or dizziness, 6. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Scapula control exercise
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
scapular strengthening 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.
Other:
No intervention
No intervention

Locations

Country Name City State
Taiwan Yin-Liang Lin Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurophysiological measures - Active motor threshold Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO). Immediately after the intervention
Primary Neurophysiological measures - Motor evoked potential Motor evoked potential (MEP) will be described with millivolt (mV). Immediately after the intervention
Primary Neurophysiological measures - Cortical silent period Cortical silent period (CSP) will be measured with millisecond (ms). Immediately after the intervention
Primary 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
Primary 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 Scapular kinematics Scapular kinematics, including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plan elevation at 30°, 60°, 90°, and 120°, will be calculated and will be described with degree (°). Immediately after the intervention
Secondary Scapular muscles activation The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated over three 30° increments of motion during arm elevation from 30° to 120°, including 30° - 60°, 60° - 90°, and 90° - 120° Immediately after the intervention
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