Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05957952
Other study ID # NYCU112007AF
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 22, 2023
Est. completion date July 1, 2024

Study information

Verified date November 2023
Source National Yang Ming University
Contact Yin-Liang Lin, PhD
Phone +886-2-2826-7288
Email yinliang@ym.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: 1. Shoulder pain located on the front or outer side. 2. The participants were only included if they were aged between 20-40 years. 3. Total participation time in shoulder exercises per week is greater than or equal to 4 hours. 4. Presence of scapular movement dysfunction. 5. 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 1. Received shoulder exercise therapy in the past three months. 2. Arm elevation angle less than 120 degrees 3. Have a history of dislocation, fracture, or surgery of upper extremity 4. A history of direct contact injury to the neck or upper extremities within the past 12 months 5. A concussion within the past 12 months or a history of three or more concussions 6. Brain injury and neurological impairment 7. History of frequent headache or dizziness 8. 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Motor control exercise with dynamic taping
Subjects will learn how to control their scapula during motor control exercise with application of dynamic tape
Motor control exercise
Subjects will learn how to control their scapula during motor control exercise without taping

Locations

Country Name City State
Taiwan National Yang Ming Chiao Tung University 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). Change from baseline AMT at the completion of the first 30-minute intervention
Primary 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 the completion of 5-session intervention, an average of 2 weeks
Primary Neurophysiological measures - Motor evoked potential Motor evoked potential (MEP) will be described with millivolt (mV). Change from baseline MEP at the completion of the first 30-minute intervention
Primary Neurophysiological measures - Motor evoked potential Motor evoked potential (MEP) will be described with millivolt (mV). Change from baseline MEP at the completion of 5-session intervention, an average of 2 weeks
Primary Neurophysiological measures - Cortical silent period Cortical silent period (CSP) will be measured with millisecond (ms). Change from baseline CSP at the completion of the first 30-minute intervention
Primary Neurophysiological measures - Cortical silent period Cortical silent period (CSP) will be measured with millisecond (ms). Change from baseline CSP at the completion of 5-session intervention, an average of 2 weeks
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 Change from baseline SICI at the completion of the first 30-minute 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 Change from baseline SICI at the completion of 5-session intervention, an average of 2 weeks
Primary 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 Change from baseline SICF at the completion of the first 30-minute intervention
Primary 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 Change from baseline SICF at the completion of 5-session intervention, an average of 2 weeks
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 (°). Change from baseline scapular kinematics at the completion of the first 30-minute 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 (°). Change from baseline scapular kinematics at the completion of 5-session intervention, an average of 2 weeks
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° Change from baseline scapular muscles activation at the completion of the first 30-minute 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° Change from baseline scapular muscles activation at the completion of 5-session intervention, an average of 2 weeks
Secondary 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. Change from baseline DASH questionnaire at the completion of 5-session intervention, an average of 2 weeks
Secondary 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). Change from baseline visual analogue scale at the completion of 5-session intervention, an average of 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04330027 - Effectiveness of Lyophilized Growth Factors for Subacromial Impingement N/A
Recruiting NCT02909920 - Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis) N/A
Completed NCT02598947 - The POST Study; POsterior Shoulder Tightness in Rotator Cuff Related Disorders N/A
Terminated NCT02669303 - Platelet-rich Plasma (PRP) Injection for Treating Shoulder Subacromial Impingement Syndrome N/A
Completed NCT02670174 - Influence of Kinetic Chain Training on the Treatment Outcome of Overhead Athletes With Impingement N/A
Active, not recruiting NCT01441830 - Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain Phase 3
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Recruiting NCT05528705 - Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome N/A
Completed NCT03667833 - Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture N/A
Completed NCT01623011 - Can Shoulder Arthroscopy Work N/A
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04014491 - The Effects of Exercise Training on Corticospinal System in Overhead Athletes With Shoulder Impingement Syndrome N/A
Completed NCT01090271 - Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome N/A
Recruiting NCT06081088 - Graded Motor Imagery Training in Shoulder Impingement Syndrome N/A
Recruiting NCT06092502 - Subacromial Pain Syndrome and Graded Motor Imagery N/A
Completed NCT05605730 - Maitland Thoracic Mobilization Versus Mulligan Thoracic Mobilization in Kyphotic Patients With Shoulder Impingement Syndrome N/A
Completed NCT04154345 - Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study N/A
Not yet recruiting NCT03554538 - Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain N/A
Recruiting NCT02285868 - ATI Evidence-based Guide Investigating Clinical Services
Completed NCT01414569 - Dexamethasone for Pain After Shoulder Surgery Phase 4