HealthyNCT05250076
Immediate Effects of Kinesio Tape on Median Nerve's Mechanosensitivity
A study testing Kinesio Tape in people with Healthy, run by University Fernando Pessoa at 1 site in Portugal.
Trial summary
The purpose of this study is to verify the immediate effects of Kinesio Tape on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 11 Feb 2022to 26 Mar 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body
Who cannot join
- Deformities in the upper quadrant region of the body;
- Complaints in this region in the last 6 months;
- Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies of the upper quadrant that may disturb nerve function;
- Not present any mechanosensitive response to ULNT1;
- Pregnant women;
- Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Kinesio Tape on Median Nerve's Mechanosensitivity, Measured by the Upper Limb Neurodynamic Test 1 (ULNT1) in Healthy Participants: A Randomized Controlled Trial
The purpose of this study is to verify the immediate effects of Kinesio Tape on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.
Read the detailed description
After completing the socio-demographic and clinical questionnaire, the participants will be randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (Kinesio tape throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest for 5 minutes), using the software www.graphpad.com/quickcals.
- Conditions
- Healthy
- Being tested
- Kinesio Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeDevice
The beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | The beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination (Posturarte® Olympic). To clean the participant's skin, cotton (MASMI®) will be passed with ethyl alcohol (Fergus®). Scissor (Maped®) will be used to cut the Kinesio Tape. Receives: Device: Kinesio Tape |
| Control Group | No intervention | The participants will remain at rest in a supine position on a treatment table (Posturarte® Olympic) without inclination for 5 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in elbow extension range of motion measured by smartphone
Data will be collected in two moments: baseline (Moment 0) and after the application of Kinesio Tape for intervention group or after a resting period for control group (Moment 1).
Moment 0 will consist in performing the ULNT1 on the dominant upper limb for each participant. The participants will remain in a supine position on a treatment table with the body aligned, exposing the test forearm for the placement of the smartphone through an armband. The head and cervical spine will be stabilized at the maximum comfortable lateral inclination using a foam pillow. The ULNT1 sequence used was: (1) maximum contralateral cervical inclination; (2) arm at 90º of shoulder abduction preventing scapular elevation; (3) 90º of external rotation of the shoulder and elbow flexion at 90º (defined as the initial position or 0º of range of motion under test); (4) supination of the forearm; (5) wrist and fingers extension; and (6) elbow extension.
Measured: [Time Frame: Baseline (Moment 0), Immediately after intervention or control (Moment 1) .]]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start11 Feb 2022
- Primary completion26 Feb 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Cardoso, PhD, Principal investigator, Fernando Pessoa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250076
- Sponsor's protocol ID
- FISIO-2-28102019
- Status last verified
- May 2022
- First submitted
- 13 Jan 2022
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Kinesio Tape on Median Nerve's Mechanosensitivity, Measured by the Upper Limb Neurodynamic Test 1 (ULNT1) in Healthy Participants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05250076
- Acronym / sponsor ID
- FISIO-2-28102019
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Fernando PessoaUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 22 Feb 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.
The purpose of this study is to verify the immediate effects of Kinesio Tape on median nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy participants.
Detailed description
After completing the socio-demographic and clinical questionnaire, the participants will be randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (Kinesio tape throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest for 5 minutes), using the software www.graphpad.com/quickcals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Kinesio TapeThe beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination (Posturarte® Olympic). To clean the participant's skin, cotton (MASMI®) will be passed with ethyl alcohol (Fergus®). Scissor (Maped®) will be used to cut the Kinesio Tape. |
| Control Group | No intervention | –The participants will remain at rest in a supine position on a treatment table (Posturarte® Olympic) without inclination for 5 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy university students of both genders with normal mobility of the joints of the upper quadrant of the body
Key exclusion criteria (6 listed)
- Deformities in the upper quadrant region of the body;
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 TapeThe beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination. | Device | Intervention Group |
Primary outcome
change in elbow extension range of motion measured by smartphone
Time frame: [Time Frame: Baseline (Moment 0), Immediately after intervention or control (Moment 1) .]]
Data will be collected in two moments: baseline (Moment 0) and after the application of Kinesio Tape for intervention group or after a resting period for control group (Moment 1). Moment 0 will consist in performing the ULNT1 on the dominant upper limb for each participant. The participants will remain in a supine position on a treatment table with the body aligned, exposing the test forearm for the placement of the smartphone through an armband. The head and cervical spine will be stabilized at the maximum comfortable lateral inclination using a foam pillow. The ULNT1 sequence used was: (1) maximum contralateral cervical inclination; (2) arm at 90º of shoulder abduction preventing scapular elevation; (3) 90º of external rotation of the shoulder and elbow flexion at 90º (defined as the initial position or 0º of range of motion under test); (4) supination of the forearm; (5) wrist and fingers extension; and (6) elbow extension.
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 20 May 2022.
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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.
Ricardo Cardoso, PhD principal investigator
Fernando Pessoa University
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 Healthy, run by University Fernando Pessoa at 1 site in Portugal.
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 6 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 20 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 Portugal. 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?
change in elbow extension range of motion measured by smartphone (time frame: [Time Frame: Baseline (Moment 0), Immediately after intervention or control (Moment 1) .]]). 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 20 May 2022.