NCT06516393

Brief Summary

This study is a prospective randomized clinical trial. Radial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Kinesio taping (KT) applied to the plantar fascia can provide patients with PF some benefits, but there no enough evidence about this topic. This study analysed the acute effect of adding KT to r-ESWT, on pain, foot function and flexibility when treating PF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 12, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

Plantar FasciitisRadial Extracorporeal Shock Wave TherapyKinesio TapingPain

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in pain on the Visual Analog Scale (VAS) at week 5

    VAS is a tool where patients indicate the level of pain they feel using a 10 cm ruler. VAS pain score "no pain" (score=0) and "worst pain" (score=10).

    Baseline and week 5

  • Change from baseline Foot function via the Foot Function Index (FFI) at week 5

    FFI is a safe and valid foot-specific assessment measure used to evaluate pain, disability, and activity limitation, filled out by the patient self-reported

    Baseline and week 5

  • Change from baseline flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests at week 5

    The patient was seated on a flat surface with the knees extended and the soles of the feet touching the wall. The tests were repeated three times and the average of the three measurements was taken.

    Baseline and week 5

Study Arms (2)

Radial extracorporeal shock wave therapy (r-ESWT) application group

EXPERIMENTAL

Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.

Device: The radial shock wave device

r-ESWT + Kinesio taping (KT) application group

ACTIVE COMPARATOR

Patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises.

Device: The radial shock wave device

Interventions

The r-ESWT+Kinesio Tape Application

Also known as: The r-ESWT+Kinesio taping (KT)
Radial extracorporeal shock wave therapy (r-ESWT) application groupr-ESWT + Kinesio taping (KT) application group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of unilateral plantar fasciitis,
  • The presence of a heel spur on a lateral radiograph

You may not qualify if:

  • Lower extremity surgeries or traumas,
  • Systemic inflammatory disease,
  • Steroid injections administered within the past six months,
  • Pacemaker usage,
  • Coagulation disorders,
  • Use of anticoagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bihter Akınoğlu

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Kocahan T, Orscelik A, Gunaydin H, Buyukluoglu G, Karaaslan B, Asar E, Akinoglu B. Can kinesio tape negatively affect the treatment by creating a hard floor in plantar fasciitis treatment? A randomized clinical trial. PLoS One. 2025 May 5;20(5):e0322397. doi: 10.1371/journal.pone.0322397. eCollection 2025.

MeSH Terms

Conditions

Fasciitis, PlantarPain

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the patients were divided into subgroups by the sports physician according to age, height, body weight and body mass index. Patients with similar characteristics were randomized to one of two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 24, 2024

Study Start

September 13, 2023

Primary Completion

April 18, 2024

Study Completion

April 30, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

All collected IPD will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Once the study is published, data will be shared.
Access Criteria
If ethics committee requirements are met in similar studies to be conducted by clinical researchers, data can be shared with the permission of the clinical officer.

Locations