Myofascial Trigger Point PainNCT05396196
An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
A study testing Kinesio® Tape in people with Myofascial Trigger Point Pain, run by North Dakota State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Kinesio® Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 27 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- acute strain or surgery to the knee, quadriceps, or hamstrings
- allergy to adhesive
- malignancies
- cellulitis
- skin infection
- diabetes
- fragile skin
Trial locations and contacts
1 site in 1 country.
United States1 site
North Dakota State University
Fargo, North Dakota, 58108
About this study
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.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Kinesio® Tape
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio® TapeDevice
Manual Fascial Glide Application
| Study group | Role | What they receive |
|---|---|---|
| Pre-Tape | Active comparator | Not described Receives: Device: Kinesio® Tape |
| With Tape 1 | Experimental | Not described Receives: Device: Kinesio® Tape |
| With Tape 2 | Experimental | Not described Receives: Device: Kinesio® Tape |
| Post-Tape | Experimental | Not described Receives: Device: Kinesio® Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
with-in subject differences pre- and 10-minute post- tape application measured by pain pressure threshold (N/s2) via algometer
Measured: 10 minutes
with-in subject differences pre- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
Measured: 48 hours
with-in subject differences 10-minute post- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
Measured: 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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start25 May 2021
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396196
- Sponsor's protocol ID
- IRB0003556
- Status last verified
- May 2022
- First submitted
- 2 Jun 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Kinesio® Tape With Manual Fascial Glide Application on Trigger Points in The Iliotibial Band
- ClinicalTrials.gov ID
- NCT05396196
- Acronym / sponsor ID
- IRB0003556
- Conditions
- Myofascial Trigger Point Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-Tape | Active comparator | Device: Kinesio® Tape |
| With Tape 1 | Experimental | Device: Kinesio® Tape |
| With Tape 2 | Experimental | Device: Kinesio® Tape |
| Post-Tape | Experimental | Device: Kinesio® Tape |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- acute strain or surgery to the knee, quadriceps, or hamstrings
- allergy to adhesive
- malignancies
- cellulitis
- skin infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio® TapeManual Fascial Glide Application | Device | Post-Tape, Pre-Tape, With Tape 1, With Tape 2 |
Primary outcome
with-in subject differences pre- and 10-minute post- tape application measured by pain pressure threshold (N/s2) via algometer
Time frame: 10 minutes
with-in subject differences pre- and 48-hour post- tape application measured by pain pressure threshold (N/s2) via algometer
Time frame: 48 hours
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio® Tape in people with Myofascial Trigger Point Pain, run by North Dakota State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
with-in subject differences pre- and 10-minute post- tape application measured by pain pressure threshold (N/s2) via algometer (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.