- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05957952
The Effects of Dynamic Taping With Exercise on Neuromuscular Control in Individuals With Subacromial Impingement
The Effects of Dynamic Taping With Exercise on Neuromuscular Control
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yin-Liang Lin, PhD
- Phone Number: +886-2-2826-7288
- Email: yinliang@ym.edu.tw
Study Locations
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Taipei, Taiwan, 112
- National Yang Ming Chiao Tung University
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Contact:
- Lin Yin-Liang, PhD
- Phone Number: +886-2-28267288
- Email: yinliang@ym.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
- Received 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 transcranial magnetic stimulation, 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Exercise group
Motor control exercise
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Subjects will learn how to control their scapula during motor control exercise without taping
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Experimental: Dynamic taping with exercise group
Motor control exercise combined with dynamic taping
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Subjects will learn how to control their scapula during motor control exercise with application of dynamic tape
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurophysiological measures - Active motor threshold
Time Frame: Change from baseline AMT at the completion of the first 30-minute intervention
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Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
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Change from baseline AMT at the completion of the first 30-minute intervention
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Neurophysiological measures - Active motor threshold
Time Frame: Change from baseline AMT at the completion of 5-session intervention, an average of 2 weeks
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Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
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Change from baseline AMT at the completion of 5-session intervention, an average of 2 weeks
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Neurophysiological measures - Motor evoked potential
Time Frame: Change from baseline MEP at the completion of the first 30-minute intervention
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Motor evoked potential (MEP) will be described with millivolt (mV).
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Change from baseline MEP at the completion of the first 30-minute intervention
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Neurophysiological measures - Motor evoked potential
Time Frame: Change from baseline MEP at the completion of 5-session intervention, an average of 2 weeks
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Motor evoked potential (MEP) will be described with millivolt (mV).
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Change from baseline MEP at the completion of 5-session intervention, an average of 2 weeks
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Neurophysiological measures - Cortical silent period
Time Frame: Change from baseline CSP at the completion of the first 30-minute intervention
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Cortical silent period (CSP) will be measured with millisecond (ms).
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Change from baseline CSP at the completion of the first 30-minute intervention
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Neurophysiological measures - Cortical silent period
Time Frame: Change from baseline CSP at the completion of 5-session intervention, an average of 2 weeks
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Cortical silent period (CSP) will be measured with millisecond (ms).
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Change from baseline CSP at the completion of 5-session intervention, an average of 2 weeks
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Neurophysiological measures - Short interval cortical inhibition
Time Frame: Change from baseline SICI at the completion of the first 30-minute intervention
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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
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Change from baseline SICI at the completion of the first 30-minute intervention
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Neurophysiological measures - Short interval cortical inhibition
Time Frame: Change from baseline SICI at the completion of 5-session intervention, an average of 2 weeks
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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
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Change from baseline SICI at the completion of 5-session intervention, an average of 2 weeks
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Neurophysiological measures - Short interval cortical facilitation
Time Frame: Change from baseline SICF at the completion of the first 30-minute intervention
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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
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Change from baseline SICF at the completion of the first 30-minute intervention
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Neurophysiological measures - Short interval cortical facilitation
Time Frame: Change from baseline SICF at the completion of 5-session intervention, an average of 2 weeks
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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
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Change from baseline SICF at the completion of 5-session intervention, an average of 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scapular kinematics
Time Frame: Change from baseline scapular kinematics at the completion of the first 30-minute intervention
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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 (°).
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Change from baseline scapular kinematics at the completion of the first 30-minute intervention
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Scapular kinematics
Time Frame: Change from baseline scapular kinematics at the completion of 5-session intervention, an average of 2 weeks
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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 (°).
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Change from baseline scapular kinematics at the completion of 5-session intervention, an average of 2 weeks
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Scapular muscles activation
Time Frame: Change from baseline scapular muscles activation at the completion of the first 30-minute intervention
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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°
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Change from baseline scapular muscles activation at the completion of the first 30-minute intervention
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Scapular muscles activation
Time Frame: Change from baseline scapular muscles activation at the completion of 5-session intervention, an average of 2 weeks
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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°
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Change from baseline scapular muscles activation at the completion of 5-session intervention, an average of 2 weeks
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Shoulder function
Time Frame: Change from baseline DASH questionnaire at the completion of 5-session intervention, an average of 2 weeks
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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.
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Change from baseline DASH questionnaire at the completion of 5-session intervention, an average of 2 weeks
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Visual analogue scale (VAS) of shoulder pain and instability
Time Frame: Change from baseline visual analogue scale at the completion of 5-session intervention, an average of 2 weeks
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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).
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Change from baseline visual analogue scale at the completion of 5-session intervention, an average of 2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU112007AF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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