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The Effect of Dynamic Tape ® on Plantar Fascitis

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ClinicalTrials.gov Identifier: NCT04022070
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Aurora Castro Mendez, University of Seville

Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date September 12, 2019
Estimated Study Start Date  ICMJE September 11, 2019
Estimated Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
Plantar fasciitis pain [ Time Frame: one ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
Plantar fasciitis pain [ Time Frame: 1 week ]
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
Change History Complete list of historical versions of study NCT04022070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dynamic Tape ® on Plantar Fascitis
Official Title  ICMJE Short-term Effect of Dynamic Tape ® on Plantar Fascitis; a Pilot Study
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 10 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 10 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 any control group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Patients with fasciitis plantar pain
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fasciitis, Plantar
  • Foot Tapping
Intervention  ICMJE Other: 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).
Study Arms  ICMJE Dynamic 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.
Intervention: Other: Dynamic Tape® (Tape)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2019
Estimated Primary Completion Date September 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of fasciitis
  • Plantar fasciitis pain

Exclusion Criteria:

Current treatment of fasciitis pain

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04022070
Other Study ID Numbers  ICMJE 27/02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Aurora Castro Mendez, University of Seville
Study Sponsor  ICMJE University of Seville
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Seville
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP