NCT05328700

Brief Summary

One of the pathologies most studied and treated with kinesiotape (KT) is plantar fasciitis (PF). In most of the studies reviewed, it is concluded that there is an improvement in the symptoms of PF when treated with KT: either combined with other therapies or as a single treatment compared to placebo. However, most current studies have limitations because the sample is small, the effect size is small, and the evidence is insufficient or of low quality. In the present work, the aim is to study the effectiveness of KT in PF, and to compare the results with those obtained in a placebo group, which is treated with tape. The researchers will assess the decrease in symptoms prior to performing other definitive treatments. In addition, the variability of the painful symptoms and the durability of the bandage will be studied, in order to determine whether it can be used in the short or long period of time, being able to take it into account and supposing a supplement to the pharmacological treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 22, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

March 22, 2022

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale of Pain

    A visual analogue scale of pain will assess from 0, no pain, to 10, the worst possible pain

    Change from baseline (before intervention) to one day, two days, three days and four days after intervention

Secondary Outcomes (1)

  • Bandage durability

    Change from baseline (the bandage is put on) until the first day that the loss of the bandage is documented, assessed up to 7 days

Study Arms (2)

kinesiotaping

EXPERIMENTAL
Other: Kinesiotaping

Tape

PLACEBO COMPARATOR
Other: Tape

Interventions

Perform a neuromuscular bandage with kinesiotape in patients with plantar fasciitis

kinesiotaping
TapeOTHER

Perform a neuromuscular bandage with tape (Hipofix(R)) in patients with plantar fasciitis

Tape

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with acute plantar fasciitis with less than 3 months of evolution
  • Who present pain in the fascia both during ambulation and on palpation
  • Ecographic image compatible with plantar fasciitis (\> 4 mm)
  • The condition has not be previously treated with other treatment

You may not qualify if:

  • Condition with no sintomatology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de València

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 14, 2022

Study Start

April 15, 2022

Primary Completion

October 29, 2022

Study Completion

October 30, 2022

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations