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The Effect of Dynamic Tape ® on Plantar Fascitis

Primary Purpose

Fasciitis, Plantar, Foot Tapping

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dynamic Tape® (Tape)
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring foot, fasciitis, tapping

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of fasciitis
  • Plantar fasciitis pain

Exclusion Criteria:

Current treatment of fasciitis pain

Sites / Locations

  • Aurora Castro Mendez

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dynamic Tape

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 5, 2019
Last Updated
February 26, 2020
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04022070
Brief Title
The Effect of Dynamic Tape ® on Plantar Fascitis
Official Title
Short-term Effect of Dynamic Tape ® on Plantar Fascitis; a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar, Foot Tapping
Keywords
foot, fasciitis, tapping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with fasciitis plantar pain
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic Tape
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic Tape® (Tape)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Plantar fasciitis pain
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of fasciitis Plantar fasciitis pain Exclusion Criteria: Current treatment of fasciitis pain
Facility Information:
Facility Name
Aurora Castro Mendez
City
Sevilla
ZIP/Postal Code
41018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Dynamic Tape ® on Plantar Fascitis

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