NCT04531306

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

May 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 4, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

19 days

First QC Date

May 21, 2020

Last Update Submit

February 5, 2021

Conditions

Myofascial Trigger Point Pain

Outcome Measures

Primary Outcomes (4)

  • with-in subject differences pre- and 10-minute post- tape application

    measured by pain pressure threshold (N/s2) via algometer

    10 minutes

  • with-in subject differences pre- and 48-hour post- tape application

    measured by pain pressure threshold (N/s2) via algometer

    48 hours

  • with-in subject differences 10-minute post- and 48-hour post- tape application

    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

    measured by pain pressure threshold (N/s2) via algometer

    10 minutes

Study Arms (4)

Pre-tape

ACTIVE COMPARATOR
Other: Kinesio® Tape

With tape 1

EXPERIMENTAL
Other: Kinesio® Tape

With tape 2

EXPERIMENTAL
Other: Kinesio® Tape

Post-tape

EXPERIMENTAL
Other: Kinesio® Tape

Interventions

Kinesio® TapeOTHER

Fascial taping technique for myofascial trigger points on the iliotibial band

Post-tapePre-tapeWith tape 1With tape 2

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • member of club sports team

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

August 28, 2020

Study Start

October 4, 2020

Primary Completion

October 23, 2020

Study Completion

November 1, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)