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An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of 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
North Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
May 21, 2020
Last Updated
February 5, 2021
Sponsor
North Dakota State University
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1. Study Identification

Unique Protocol Identification Number
NCT04531306
Brief Title
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band
Official Title
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2020 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
November 1, 2020 (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

5. Study Description

Brief Summary
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.

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
50 (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
Other
Intervention Name(s)
Kinesio® Tape
Intervention Description
Fascial taping technique for myofascial trigger points on the iliotibial band
Primary Outcome Measure Information:
Title
with-in subject differences pre- and 10-minute post- tape application
Description
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
Description
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
Description
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
Description
measured by pain pressure threshold (N/s2) via algometer
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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 on Myofascial Pain Syndrome of the Iliotibial Band

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