- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04711447
Effect of Inhibitory Kinesio-tape of the Upper Trapezius on Lower Trapezius Muscle Excitation
January 14, 2021 updated by: Trisha Scribbans
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- University of Manitoba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- right-handed individuals
- no current shoulder pain or pathology in the shoulder, neck, back.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: no-tape, experimental KT, sham KT
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.
|
Twenty-one 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).
|
OTHER: no-tape, sham KT, experimental KT
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).
|
Twenty-one 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole-muscle activation
Time Frame: Measured during the arm elevation task
|
RMS measured using high-density EMG electrode grids
|
Measured during the arm elevation task
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatial distribution of muscle activation
Time Frame: Measured during the arm elevation task
|
shifts in excitation measured using high-density EMG electrode grids
|
Measured during the arm elevation task
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Trisha Scribbans, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2020
Primary Completion (ACTUAL)
July 1, 2020
Study Completion (ACTUAL)
July 1, 2020
Study Registration Dates
First Submitted
January 12, 2021
First Submitted That Met QC Criteria
January 14, 2021
First Posted (ACTUAL)
January 15, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS22668 (E2019:019)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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