Kinesio Tape Application in the Treatment of Plantar Fasciitis

Can Kinesio Tape Negatively Affect the Treatment by Creating a Hard Floor in Plantar Fasciitis Treatment: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: The radial shock wave device

Detailed Description

The study was performed on 42 patients with unilateral PF, that were randomly assigned into wo groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients' pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was assessed through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Bihter Akınoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radial extracorporeal shock wave therapy (r-ESWT) application group; 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; The r-ESWT+Kinesio Tape Application; Other Names: The r-ESWT+Kinesio taping (KT)
Active Comparator: r-ESWT + Kinesio taping (KT) application group; 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; The r-ESWT+Kinesio Tape Application; Other Names: The r-ESWT+Kinesio taping (KT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bihter Aslanyurek

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Kinesio Taping; Plantar Fasciitis; Radial Extracorporeal Shock Wave Therapy
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: GEAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD will be shared
• IPD Sharing Time Frame: Once the study is published, data will be shared.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No