Myofascial Trigger Point PainNCT04531306
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of 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
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Kinesio® Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2020to 1 Nov 2020
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- member of club sports team
Who cannot join
- 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
Show all 9Show fewer
- 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
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.
- 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® TapeOther
Fascial taping technique for myofascial trigger points on the iliotibial band
| Study group | Role | What they receive |
|---|---|---|
| Pre-tape | Active comparator | Not described Receives: Other: Kinesio® Tape |
| With tape 1 | Experimental | Not described Receives: Other: Kinesio® Tape |
| With tape 2 | Experimental | Not described Receives: Other: Kinesio® Tape |
| Post-tape | Experimental | Not described Receives: Other: 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: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start4 Oct 2020
- Primary completion23 Oct 2020
- Study completion1 Nov 2020
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
- 50 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
- NCT04531306
- Sponsor's protocol ID
- HE20151
- Status last verified
- Feb 2021
- First submitted
- 21 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band
- ClinicalTrials.gov ID
- NCT04531306
- Acronym / sponsor ID
- HE20151
- Conditions
- Myofascial Trigger Point Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North Dakota State UniversityUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 28 Aug 2020 (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.
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 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 | Other: Kinesio® Tape |
| With tape 1 | Experimental | Other: Kinesio® Tape |
| With tape 2 | Experimental | Other: Kinesio® Tape |
| Post-tape | Experimental | Other: Kinesio® Tape |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- member of club sports team
Key exclusion criteria (9 listed)
- acute quadriceps strain in last six months
- knee surgery in last six months
- acute hamstring strain in last six months
- allergy to adhesive
- malignancies
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® TapeFascial taping technique for myofascial trigger points on the iliotibial band | Other | Post-tape, Pre-tape, With tape 1, With tape 2 |
Primary outcome
with-in subject differences pre- and 10-minute post- tape application
Time frame: 10 minutes
measured by pain pressure threshold (N/s2) via algometer
with-in subject differences pre- and 48-hour post- tape application
Time frame: 48 hours
measured by pain pressure threshold (N/s2) via algometer
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
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
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 9 Feb 2021.
- 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 9 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 9 Feb 2021. 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 (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 9 Feb 2021.