- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531306
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band
February 5, 2021 updated by: North Dakota State University
Participants will report for two research sessions.
Prior to arrival, membership to a club sports team will be confirmed via email.
The first session will require one hour, while the second will require 30 minutes.
Maximum amount of time expected is one and a half hours, over two sessions in 48 hours.
The 1st and 2nd sessions will be separated by 48 hours.
Upon arrival for session 1, informed consent will be obtained along with the following demographic information: age, sex, height, weight, dominant leg, and sport.
Next, the participant will complete the Musculoskeletal Questionnaire (MQ) in regard to the last 12 months.
Participants will then be assessed for trigger points in their dominant side iliotibial band via palpation.
Diagnostic criteria for trigger point will be modeled after Travell and Simons: taut band, pain upon palpation, referred pain, and a local twitch response.
Up to four trigger points will be marked on the subject's skin with marker or pen.
Pain pressure threshold will be obtained via algometer, using the terminology "Tell me the first moment you experience pain by verbalizing 'pain' ".
Then, three pain pressure threshold readings will be taken per trigger point and then averaged by the researcher.
Kinesiology tape will then be applied to the identified trigger points using the Fascial Technique.
Pain pressure threshold will be obtained again with the same protocols 10 minutes after the tape is applied.
The participant will be asked to wear the tape for 48 hours.
Upon arrival for session 2, the application of the tape will be confirmed.
With the participant's choice to continue in the study, a third and fourth measurement of pain pressure threshold will be obtained: one with the tape remaining on, and another 10 minutes after removal of the tape.
Again, three pain pressure threshold readings will be taken per trigger point and then averaged by the researcher.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
North Dakota
-
Fargo, North Dakota, United States, 58108
- North Dakota State University
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- member of club sports team
Exclusion Criteria:
- acute quadriceps strain in last six months
- knee surgery in last six months
- acute hamstring strain in last six months
- allergy to adhesive
- malignancies
- cellulitis
- skin infection
- diabetes
- fragile skin
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pre-tape
|
Fascial taping technique for myofascial trigger points on the iliotibial band
|
|
Experimental: With tape 1
|
Fascial taping technique for myofascial trigger points on the iliotibial band
|
|
Experimental: With tape 2
|
Fascial taping technique for myofascial trigger points on the iliotibial band
|
|
Experimental: Post-tape
|
Fascial taping technique for myofascial trigger points on the iliotibial band
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
with-in subject differences pre- and 10-minute post- tape application
Time Frame: 10 minutes
|
measured by pain pressure threshold (N/s2) via algometer
|
10 minutes
|
|
with-in subject differences pre- and 48-hour post- tape application
Time Frame: 48 hours
|
measured by pain pressure threshold (N/s2) via algometer
|
48 hours
|
|
with-in subject differences 10-minute post- and 48-hour post- tape application
Time Frame: 48 hours
|
measured by pain pressure threshold (N/s2) via algometer
|
48 hours
|
|
with-in subject differences 48-hour post- tape application and post- 10- minute tape removal
Time Frame: 10 minutes
|
measured by pain pressure threshold (N/s2) via algometer
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 4, 2020
Primary Completion (Actual)
October 23, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE20151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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