Fasciitis, PlantarNCT04022070
The Effect of Dynamic Tape ® on Plantar Fascitis
A study testing Dynamic Tape® (Tape) in people with Fasciitis, Plantar and Foot Tapping, run by University of Seville at 1 site in Spain.
Trial summary
The Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape material , greater than 200% elastic has manufactured in Asia. The material and adhesive arefast drying and breathable meaning that the tape, if it is correctly applied may stay on for up to 5 days, bearingin mind that if any… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fasciitis, Plantar, Foot Tapping
- What is being tested?
- Dynamic Tape® (Tape)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 11 Sep 2019to 30 Sep 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of fasciitis
- Plantar fasciitis pain
Who cannot join
- Current treatment of fasciitis pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effect of Dynamic Tape ® on Plantar Fascitis; a Pilot Study
The Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape material , greater than 200% elastic has manufactured in Asia. The material and adhesive arefast drying and breathable meaning that the tape, if it is correctly applied may stay on for up to 5 days, bearingin mind that if any discomfort, itching, burning, stinging orirritation is felt immediate removal is strongly advised.
Usually tapes are applied in plantar fasciitis to improve the symptoms. The fasciitis plantar is an pain that sometimes incapacitates the physical activity of the patients.
Read the detailed description
Objective: To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage in a sample of 15 amateur athletes affected by plantar fasciitis. The assessment will be performed using an analogue visual scale (EVA). Material and methods: the aim of the study is to evaluate a group of 15 amateur athletic subjects , all individuals suffering plantar fasciitis without any previous or current treatment. The age, from 18 to 65 years old. Samplings will be performed intentionally without a control group.
The control group will use a Low-dye tape and will be evaluated before and after a week
- Conditions
- Fasciitis, Plantar, Foot Tapping
- Being tested
- Dynamic Tape® (Tape)
- Keywords
- foot, fasciitis, tapping
- Medical subject headings
- Fasciitis, Plantar, Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Tape® (Tape)Other
To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage affected by plantar fasciitis during a week the Outcome Measure, pain is evaluate with a VAS (visual pain scale).
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Tape | Other | To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage in a sample of subjects affected by plantar fasciitis. Receives: Other: Dynamic Tape® (Tape) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar fasciitis pain
Evaluation before and after a week of use of a Dynamic Tape. Visual analogic scale.
The visual analogue scale (VAS) is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The Primary and second Outcome Measures (pain, VAS) . Time Frame includes more than one time point. The initial evaluation, the day of inclusion in the study and the second one a week after the use of the tape
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start11 Sep 2019
- Primary completion11 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with fasciitis plantar pain
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Castro Mendez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022070
- Sponsor's protocol ID
- 27/02
- Status last verified
- Feb 2020
- First submitted
- 5 Jul 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Dynamic Tape ® on Plantar Fascitis; a Pilot Study
- ClinicalTrials.gov ID
- NCT04022070
- Acronym / sponsor ID
- 27/02
- Conditions
- Fasciitis, Plantar, Foot Tapping
- Keywords
- foot, fasciitis, tapping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 16 Jul 2019 (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 Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape material , greater than 200% elastic has manufactured in Asia. The material and adhesive arefast drying and breathable meaning that the tape, if it is correctly applied may stay on for up to 5 days, bearingin mind that if any discomfort, itching, burning, stinging orirritation is felt immediate removal is strongly advised.
Usually tapes are applied in plantar fasciitis to improve the symptoms. The fasciitis plantar is an pain that sometimes incapacitates the physical activity of the patients.
Detailed description
Objective: To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage in a sample of 15 amateur athletes affected by plantar fasciitis. The assessment will be performed using an analogue visual scale (EVA). Material and methods: the aim of the study is to evaluate a group of 15 amateur athletic subjects , all individuals suffering plantar fasciitis without any previous or current treatment. The age, from 18 to 65 years old. Samplings will be performed intentionally without a control group.
The control group will use a Low-dye tape and will be evaluated before and after a week
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with fasciitis plantar pain
| Arm | Type | Receives |
|---|---|---|
| Dynamic Tape | Other | Other: Dynamic Tape® (Tape)To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage in a sample of subjects affected by plantar fasciitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of fasciitis
- Plantar fasciitis pain
Key exclusion criteria (1 listed)
- Current treatment of fasciitis pain
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 |
|---|---|---|
| Dynamic Tape® (Tape)To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage affected by plantar fasciitis during a week the Outcome Measure, pain is evaluate with a VAS (visual pain scale). | Other | Dynamic Tape |
Primary outcome
Plantar fasciitis pain
Time frame: 7 days
Evaluation before and after a week of use of a Dynamic Tape. Visual analogic scale. The visual analogue scale (VAS) is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The Primary and second Outcome Measures (pain, VAS) . Time Frame includes more than one time point. The initial evaluation, the day of inclusion in the study and the second one a week after the use of the tape
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 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 Dynamic Tape® (Tape) in people with Fasciitis, Plantar and Foot Tapping, run by University of Seville at 1 site in Spain.
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 2 inclusion and 1 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 28 Feb 2020. 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 Spain. 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?
Plantar fasciitis pain (time frame: 7 days). 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 28 Feb 2020.