Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping in Football Players

February 20, 2023 updated by: Riphah International University

Comparative Effects of Calcaneal Low Dye Taping Plantar Fascial Stretching and Sham Taping on Acute Plantar Heal Pain and Functional Activity Level in Football Players

Showing the effect of calcaneal Low-dye Taping on acute planter heel pain and functional activity level in football players.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Planter fascia is a fibrous connective tissue originate from the medial calcaneal tubercle and help support the arch of the foot repetitive tensile overload from standing for long periods of time or running causes changes in the aponeurosis. Patient mostly present with pain on first step in the morning or after long non-weight bearing , Tenderness to anterior medial head. Its can first be treated conservatively where 90 % cases treated greater then 6 months of duration. Baseline treatment is given as Rest , Ice , compression and Elevation , with this NSAID ,shoe inset ,Taping, orthotics, deep friction massage and precautions are advised to the patients. Arch taping is most probably used and orthotics in acute treatment is commonly preferred due to its cost.Taping effects most probably overlooked in general gait parameters, patient feedback on pain relief and function recovery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Surya Azeem Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both male and female football players
  • Age (20-45 yrs)
  • Pain with the first step upon walking
  • Pain located at the heel or Planter surface of Mid-foot consistent with Planter fasciitis
  • Presence of an everted calcaneus greater than or equal to 2°

Exclusion Criteria:

  • Patient with surgery and treatment with previous 6 month
  • History of Ankle or foot fracture
  • Congenital deformity of the foot and ankle
  • Sever Spasticity
  • Use of an Assistive device
  • Bilateral Planter heel pain
  • Refusal to participate in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-Dye taping
out of 21 participants 7 will be included in the study design as an experimental group using low-dye taping in acute stage
Other: Low-dye taping
Low-dye taing using 4 tapes around calcaneam
Active Comparator: Plantar fascia stretching
out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage
Other: Plantar fascia stretching
out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage
Placebo Comparator: Sham taping
out of 21 participants 7 will be included in the study design as an active participants group using plantar fscia stretching in acute stage
Other: sham taping
out of 21 participants 7 will be included in the study design as an plecebo group using sham taping in acute stage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
numeric pain rating scale
Time Frame: 3 week
The Numeric Pain Rating Scale (NPRS) is a famous strategy to evaluate Pain. The NPRS has a dependable, substantial and delicate instrument to survey torment. Torment score as per the NPRS (0-10), made during the principal strides toward the beginning of the day, was the essential result (0 as "no aggravation" and 10 as "exceptionally serious agony").
3 week
foot and ankle disability index
Time Frame: 3 week
It is utilized to evaluate the utilitarian restrictions connected with foot and lower leg, action of day to day living and most troublesome errand that are vital for sports e.g., Walk, word related execution, Agony, Rest and Strength. The foot and ankle disability index (FADI) is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability. The total FADI score corresponds to the sum of Activity and Pain subscale scores (maximum score of 88 for Activity and 16 for Pain).
3 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatima Dr Tariq, Phd, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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