An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
Primary Purpose
Myofascial Trigger Point Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinesio® Tape
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Trigger Point Pain
Eligibility Criteria
Inclusion Criteria:
- Recreationally active per the American College of Sports Medicine or Recreational runners will have to report at least 10 miles a week for the last three months.
Exclusion Criteria:
- acute strain or surgery to the knee, quadriceps, or hamstrings
- allergy to adhesive
- malignancies
- cellulitis
- skin infection
- diabetes
- fragile skin
Sites / Locations
- North Dakota State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Pre-Tape
With Tape 1
With Tape 2
Post-Tape
Arm Description
Outcomes
Primary Outcome Measures
with-in subject differences pre- and 10-minute post- tape application measured by pain pressure threshold (N/s2) via algometer
with-in subject differences pre- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
with-in subject differences 10-minute post- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
with-in subject differences 48-hour post- tape application and post- 10- minute tape removal measured by pain pressure threshold (N/s2) via algometer
Secondary Outcome Measures
Full Information
NCT ID
NCT05396196
First Posted
June 2, 2021
Last Updated
May 24, 2022
Sponsor
North Dakota State University
1. Study Identification
Unique Protocol Identification Number
NCT05396196
Brief Title
An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
Official Title
An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Dakota State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Up to 15 participants between the ages of 18-55 will report for two research sessions. Prior to arrival, minimum requirements for being recreationally active or a recreational runner will be confirmed via email using the Pre-Participation Screening form. 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 activity. 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 and pain upon palpation. One 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 'now'. Then, three pain pressure threshold readings will be taken per trigger point and then averaged by the researcher. Following, a Visual Analogue Scale for pain will be assessed by asking the question 'On average, on a scale from 0-10 how painful was the pressure?' Kinesiology tape will then be applied to the identified trigger points using the Manual Fascial Glide. The Manual Fascial Glide will be applied with one 'I' strip horizontal to each trigger point. The tape will be anchored adjacent to the marked trigger point, a gentle pressure will be placed on the anchor while applying a lateral glide of the superficial tissue, and adhering the tape in the opposite direction at 30% tension. 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. Next, a second VAS for pain regarding the previous 48 hours will be completed by the participant. 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.
Regarding the new Covid-19 protocols for face-to-face research studies, the following protection guidelines will be followed according to the IRB recommendations. All participants will be seen individually, with no other participants in the research area at the same time. Due to the extended interaction, all participants and researchers will be required to wear a face covering, which covers their mouth and nose at all times while in the research area. The researcher will also wear a face covering over nose and mouth at all times in the research area. This study does not include any high exertion exercise which would increase the risk of infection. Physical distancing of 2 meters between the participant and the researcher will be maintained before and after any necessary close contact evaluation or tape application. All equipment (algometer, computer, examination tables, stools/chairs, pens, scissors, adherent spray bottle, hair trimmer) will be disinfected between each participant. Any disposable equipment (isopropyl alcohol pads, tape, or tape paper) will be disposed of immediately after use. The researcher will wash hands before and after each physical interaction with participants according to the CDC guidelines. Ventilation will be considered in the research area by allowing the door to remain open if the participant allows. Finally, the IRB approved COVID-19 screening questions will be presented to the participant before any part of the research study is completed. If any person answers 'yes' to any of the questions, they cannot participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-Tape
Arm Type
Active Comparator
Arm Title
With Tape 1
Arm Type
Experimental
Arm Title
With Tape 2
Arm Type
Experimental
Arm Title
Post-Tape
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Kinesio® Tape
Intervention Description
Manual Fascial Glide Application
Primary Outcome Measure Information:
Title
with-in subject differences pre- and 10-minute post- tape application measured by pain pressure threshold (N/s2) via algometer
Time Frame
10 minutes
Title
with-in subject differences pre- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
Time Frame
48 hours
Title
with-in subject differences 10-minute post- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
Time Frame
48 hours
Title
with-in subject differences 48-hour post- tape application and post- 10- minute tape removal measured by pain pressure threshold (N/s2) via algometer
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recreationally active per the American College of Sports Medicine or Recreational runners will have to report at least 10 miles a week for the last three months.
Exclusion Criteria:
acute strain or surgery to the knee, quadriceps, or hamstrings
allergy to adhesive
malignancies
cellulitis
skin infection
diabetes
fragile skin
Facility Information:
Facility Name
North Dakota State University
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
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