NCT05736809

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

January 4, 2023

Last Update Submit

February 20, 2023

Conditions

Keywords

Calcaneal Taping, ,Plantar Fascia,Low Dye TapingFoot,

Outcome Measures

Primary Outcomes (2)

  • numeric pain rating scale

    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

    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

Study Arms (3)

Low-Dye taping

EXPERIMENTAL

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

Plantar fascia stretching

ACTIVE COMPARATOR

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

Sham taping

PLACEBO COMPARATOR

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

Interventions

Low-dye taing using 4 tapes around calcaneam

Low-Dye 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

Plantar fascia stretching

out of 21 participants 7 will be included in the study design as an plecebo group using sham taping in acute stage

Sham taping

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surya Azeem Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

  • Fatima Dr Tariq, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study would be a RCT (Randomized control trial) at Pakistan sports board in which convenience sampling technique would be used .This study include total 21 participants and for this purpose lotare method would be used to select the participants on comparison of calcaneal taping , planter fascia stretching and sham taping for one week for acute treatment . Each groups contain 7 participants with heel pain with baseline treatment will be given to each of the groups .
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

February 21, 2023

Study Start

December 19, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations