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The Effects of Dynamic Taping With Exercise on Neuromuscular Control in Individuals With Subacromial Impingement

Primary Purpose

Shoulder Impingement Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Motor control exercise with dynamic taping
Motor control exercise
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder Impingement Syndrome, Transcranial magnetic stimulation, Dynamic tape, Corticospinal system, Scapular control exercise, Kinematics, Muscle activation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Shoulder pain located on the front or outer side. The participants were only included if they were aged between 20-40 years. Total participation time in shoulder exercises per week is greater than or equal to 4 hours. Presence of scapular movement dysfunction. Presence of shoulder impingement symptoms, with at least 3 positive results in the following 6 tests: Painful arc test Neer's impingement test Hawkins-Kennedy impingement test Empty can test Resisted external rotation test Tenderness of the rotator cuff tendons Exclusion Criteria Receivd shoulder exercise therapy in the past three months. Arm elevation angle less than 120 degrees 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.

Sites / Locations

  • National Yang Ming Chiao Tung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Exercise group

Dynamic taping with exercise group

Arm Description

Motor control exercise

Motor control exercise combined with dynamic taping

Outcomes

Primary Outcome Measures

Neurophysiological measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Neurophysiological measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Neurophysiological measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV).
Neurophysiological measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV).
Neurophysiological measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms).
Neurophysiological measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms).
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
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
Neurophysiological measures - Short interval cortical facilitation
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Neurophysiological measures - Short interval cortical facilitation
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms

Secondary Outcome Measures

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 (°).
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 (°).
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°
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°
Shoulder function
Shoulder function will be measured by the disabilities of the arm, shoulder and hand (DASH) questionnaire, including the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). A higher score indicates greater disability.
Visual analogue scale (VAS) of shoulder pain and instability
Shoulder pain and instability will be measured by visual analogue scale (VAS). Subjects need to mark the point that they feel represent their perception of their current state on a 10-cm line. Scores range from 0 (no symptom) to 100 (maximum symptom).

Full Information

First Posted
July 2, 2023
Last Updated
July 14, 2023
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05957952
Brief Title
The Effects of Dynamic Taping With Exercise on Neuromuscular Control in Individuals With Subacromial Impingement
Official Title
The Effects of Dynamic Taping With Exercise on Neuromuscular Control
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Subacromial Impingement Syndrome (SIS) is the commonest disorder of the shoulder, accounting for 44%-65% of all complaints of shoulder pain. Previous studies have found kinematic changes and alterations in muscle activation amplitude or timing. Recent studies also show the different organization of the corticospinal system in patients with SIS and alterations in central motor representation in individuals with rotator cuff tendinopathy. To restore kinematic changes and muscle activation in patients with SIS, treatments of patients with SIS commonly include motor control exercise and taping. However, there are different types of taping with different properties and purposes resulting in inconsistent outcomes. Recently, a new taping technique, Dynamic tape whose properties are between the most common taping Kinesio tape and rigid tape may solve the questions above. But the evidence of the effect of Dynamic tape and the additional effect of Dynamic tape with motor control exercises are still not well understood. Purpose: The purpose of this study is to investigate the additional effects of Dynamic taping with motor control exercise compared to motor control exercise alone on kinematic, muscle activity, corticospinal excitability, pain and function in people with subacromial Impingement Syndrome. Methods: This is a randomized control trial. Fifty individuals with SIS will be randomly assigned into either an exercise group or dynamic tape with exercise group. Both groups will receive 5 sessions of treatment in 2 weeks, with 30 minutes per sessions. Outcomes will be measured at baseline, after the first intervention and following 2-week intervention. Primary outcome measures will include scapular kinematics, scapular muscle activation and corticospinal system. Secondary outcome measures included shoulder pain by a numeric pain rating scale and shoulder function by the disability of the arm, shoulder & hand scale (DASH). Data analysis: two-way and three-way mixed ANOVA will used to compare the intervention effect of two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Shoulder Impingement Syndrome, Transcranial magnetic stimulation, Dynamic tape, Corticospinal system, Scapular control exercise, Kinematics, Muscle activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Sham Comparator
Arm Description
Motor control exercise
Arm Title
Dynamic taping with exercise group
Arm Type
Experimental
Arm Description
Motor control exercise combined with dynamic taping
Intervention Type
Procedure
Intervention Name(s)
Motor control exercise with dynamic taping
Intervention Description
Subjects will learn how to control their scapula during motor control exercise with application of dynamic tape
Intervention Type
Procedure
Intervention Name(s)
Motor control exercise
Intervention Description
Subjects will learn how to control their scapula during motor control exercise without tapine
Primary Outcome Measure Information:
Title
Neurophysiological measures - Active motor threshold
Description
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Time Frame
Change from baseline AMT at the completion of the first 30-minute intervention
Title
Neurophysiological measures - Active motor threshold
Description
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Time Frame
Change from baseline AMT at the completion of 5-session intervention, an average of 2 weeks
Title
Neurophysiological measures - Motor evoked potential
Description
Motor evoked potential (MEP) will be described with millivolt (mV).
Time Frame
Change from baseline MEP at the completion of the first 30-minute intervention
Title
Neurophysiological measures - Motor evoked potential
Description
Motor evoked potential (MEP) will be described with millivolt (mV).
Time Frame
Change from baseline MEP at the completion of 5-session intervention, an average of 2 weeks
Title
Neurophysiological measures - Cortical silent period
Description
Cortical silent period (CSP) will be measured with millisecond (ms).
Time Frame
Change from baseline CSP at the completion of the first 30-minute intervention
Title
Neurophysiological measures - Cortical silent period
Description
Cortical silent period (CSP) will be measured with millisecond (ms).
Time Frame
Change from baseline CSP at the completion of 5-session intervention, an average of 2 weeks
Title
Neurophysiological measures - Short interval cortical inhibition
Description
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
Time Frame
Change from baseline SICI at the completion of the first 30-minute intervention
Title
Neurophysiological measures - Short interval cortical inhibition
Description
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
Time Frame
Change from baseline SICI at the completion of 5-session intervention, an average of 2 weeks
Title
Neurophysiological measures - Short interval cortical facilitation
Description
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Time Frame
Change from baseline SICF at the completion of the first 30-minute intervention
Title
Neurophysiological measures - Short interval cortical facilitation
Description
Short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses while the inter-stimulus interval is above 5 ms
Time Frame
Change from baseline SICF at the completion of 5-session intervention, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Scapular kinematics
Description
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 (°).
Time Frame
Change from baseline scapular kinematics at the completion of the first 30-minute intervention
Title
Scapular kinematics
Description
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 (°).
Time Frame
Change from baseline scapular kinematics at the completion of 5-session intervention, an average of 2 weeks
Title
Scapular muscles activation
Description
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°
Time Frame
Change from baseline scapular muscles activation at the completion of the first 30-minute intervention
Title
Scapular muscles activation
Description
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°
Time Frame
Change from baseline scapular muscles activation at the completion of 5-session intervention, an average of 2 weeks
Title
Shoulder function
Description
Shoulder function will be measured by the disabilities of the arm, shoulder and hand (DASH) questionnaire, including the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). A higher score indicates greater disability.
Time Frame
Change from baseline DASH questionnaire at the completion of 5-session intervention, an average of 2 weeks
Title
Visual analogue scale (VAS) of shoulder pain and instability
Description
Shoulder pain and instability will be measured by visual analogue scale (VAS). Subjects need to mark the point that they feel represent their perception of their current state on a 10-cm line. Scores range from 0 (no symptom) to 100 (maximum symptom).
Time Frame
Change from baseline visual analogue scale at the completion of 5-session intervention, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Shoulder pain located on the front or outer side. The participants were only included if they were aged between 20-40 years. Total participation time in shoulder exercises per week is greater than or equal to 4 hours. Presence of scapular movement dysfunction. Presence of shoulder impingement symptoms, with at least 3 positive results in the following 6 tests: Painful arc test Neer's impingement test Hawkins-Kennedy impingement test Empty can test Resisted external rotation test Tenderness of the rotator cuff tendons Exclusion Criteria Receivd shoulder exercise therapy in the past three months. Arm elevation angle less than 120 degrees 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yin-Liang Lin, PhD
Phone
+886-2-2826-7288
Email
yinliang@ym.edu.tw
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Yin-Liang, PhD
Phone
+886-2-28267288
Email
yinliang@ym.edu.tw

12. IPD Sharing Statement

Learn more about this trial

The Effects of Dynamic Taping With Exercise on Neuromuscular Control in Individuals With Subacromial Impingement

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