NCT05957952

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

July 2, 2023

Last Update Submit

May 19, 2025

Conditions

Keywords

Shoulder Impingement SyndromeTranscranial magnetic stimulationDynamic tapeCorticospinal systemScapular control exerciseKinematicsMuscle activation

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Scapular kinematics

    Change from baseline scapular kinematics at the completion of the first 30-minute intervention

  • Scapular kinematics

    Change from baseline scapular kinematics at the completion of 5-session intervention, an average of 2 weeks

  • Scapular muscles activation

    Change from baseline scapular muscles activation at the completion of the first 30-minute intervention

  • Scapular muscles activation

    Change from baseline scapular muscles activation at the completion of 5-session intervention, an average of 2 weeks

  • Shoulder function

    Change from baseline DASH questionnaire at the completion of 5-session intervention, an average of 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exercise group

SHAM COMPARATOR

Motor control exercise

Procedure: Motor control exercise

Dynamic taping with exercise group

EXPERIMENTAL

Motor control exercise combined with dynamic taping

Procedure: Motor control exercise with dynamic taping

Interventions

Subjects will learn how to control their scapula during motor control exercise with application of dynamic tape

Dynamic taping with exercise group

Subjects will learn how to control their scapula during motor control exercise without taping

Exercise group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan, 112, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

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

July 2, 2023

First Posted

July 24, 2023

Study Start

November 22, 2023

Primary Completion

August 28, 2024

Study Completion

June 30, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations