NCT04711447

Brief Summary

Shoulder pain increases excitation (or activity) of the upper trapezius (UT) and reduces excitation in lower trapezius (LT). Despite inconclusive evidence, kinesio-tape (KT) is often used to modify muscular excitation within the UT and/or LT to help correct alterations in scapular position and motion associated with shoulder pain/injury. The objectives of the current study were to determine if: 1) inhibitory KT to the UT acutely increases muscle excitation (whole-muscle and spatial distribution) within the LT in healthy individuals; and 2) if loading the limb alters the magnitude of change in muscle excitation of the LT. We hypothesize that: 1) inhibitory KT application to the UT will immediately increase whole-muscle LT excitation, and result in an inferior shift in the distribution of excitation within the LT compared to no tape and sham-KT tape conditions; and 2) the magnitude of immediate increase in LT excitation with KT would be greater in the loaded condition. A repeated-measures, crossover design was used to determine the impact of KT applied to UT and load on muscle excitation of the LT. Participants were asked to perform a repeated arm elevation task during three different taping conditions: no KT, experimental KT and sham KT. Each taping condition performed the repeated arm elevation task during two loading conditions: no load and loaded with 2.3 kilograms. All six conditions were tested during one visit with the no load condition preceding the loaded condition for each taping condition. A baseline trial (no KT; N-KT) was performed first, followed by both an experimental-KT (E-KT) and sham-KT (S-KT) condition. The order of the E-KT and S-KT conditions were randomized and the order was counterbalanced. Testing for each tape condition lasted approximately 10-minutes for a total of 45-minutes per participant including screening, EMG set-up and clean-up. KT was applied to the UT and muscle excitation (EMG amplitude) was measured in the LT using one single 32-grid high-density surface electromyography (HD-sEMG) electrode during a repeated arm elevation task.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
4 years until next milestone

Results Posted

Study results publicly available

January 27, 2025

Completed
Last Updated

January 27, 2025

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

January 12, 2021

Results QC Date

March 14, 2023

Last Update Submit

December 20, 2024

Conditions

Keywords

kinesio tape (KT)Shoulderupper trapeziuslower trapezius

Outcome Measures

Primary Outcomes (1)

  • Whole-muscle Activation

    RMS measured using high-density EMG electrode grids

    Measured during 2nd-9th repetitions of the arm elevation task. Each repetition lasted approximately 1.5 seconds, thus the timeframe was approximately 12 seconds.

Secondary Outcomes (1)

  • Spatial Distribution of Muscle Activation

    Measured during 2nd-9th repetitions of the arm elevation task. Each repetition lasted approximately 1.5 seconds, thus the timeframe was approximately 12 seconds.

Study Arms (2)

no-tape, experimental KT, sham KT

OTHER

Participants were asked to perform a repeated arm elevation task during three different taping conditions: no KT, experimental KT and sham KT. Each taping condition performed the repeated arm elevation task during two loading conditions: no load and loaded with 2.3 kilograms. All six conditions were tested during one visit with the no load condition preceding the loaded condition for each taping condition. This trial consisted of a baseline trial (no KT; N-KT) that was performed first, followed by both an experimental-KT (E-KT) and sham-KT (S-KT) condition.

Device: kinesio-tape

no-tape, sham KT, experimental KT

OTHER

Participants were asked to perform a repeated arm elevation task during three different taping conditions: no KT, experimental KT and sham KT. Each taping condition performed the repeated arm elevation task during two loading conditions: no load and loaded with 2.3 kilograms. All six conditions were tested during one visit with the no load condition preceding the loaded condition for each taping condition. This trial consisted of a baseline trial (no KT; N-KT) that was performed first, followed by both a sham-KT (S-KT) condition and experimental-KT (E-KT).

Device: kinesio-tape

Interventions

Twenty-two individuals with healthy shoulders completed 10 repetitions of an arm elevation task during three taping conditions (no-tape, experimental KT, sham KT) and 2 loading conditions (no-load and loaded).

no-tape, experimental KT, sham KTno-tape, sham KT, experimental KT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • right-handed individuals
  • no current shoulder pain or pathology in the shoulder, neck, back.

You may not qualify if:

  • recent history (\<6 months) of injury or orthopedic disorder of the shoulder, upper back or neck (e.g. rotator cuff tears, disc pathologies, etc.)
  • neurological or musculoskeletal disorder (e.g. epilepsy, multiple sclerosis, etc.)
  • current pain in the shoulder, upper back or neck
  • previous allergies or skin irritation to adhesives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Limitations and Caveats

No washout period utilized could lead to compounding effects of the kinesio-tape or sham tape conditions.

Results Point of Contact

Title
Dr. Trisha Scribbans
Organization
University of Manitoba

Study Officials

  • Trisha Scribbans

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 15, 2021

Study Start

January 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 27, 2025

Results First Posted

January 27, 2025

Record last verified: 2024-12

Locations