NCT06055933

Brief Summary

Type of this study: Prospective randomized controlled study. Purpose: The aim of this study is to compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock Therapy (ESWT). To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis who received KT application in addition to ESWT treatment. To compare the acute effect of pain level, lower extremity functionality level and plantar fascia flexibility in patients with plantar fasciitis receiving placebo application. 90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT (n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT acutely in the treatment of plantar fasciitis?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

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

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

October 2, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

7 days

First QC Date

September 20, 2023

Last Update Submit

December 20, 2024

Conditions

Keywords

Plantar fasciitisextracorporeal shock wave therapyESWTplacebo ESWTplantar fasciaKinesio Taping

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    ). VAS, with numbers from 0 to 10 on a 10 cm horizontal line; 0 means "no pain"; It was stated to the patients that 10 represented "unbearable pain". The degree of pain was recorded numerically between 0 and 10

    baseline, post treatment (at 1th week)

Secondary Outcomes (1)

  • Lower Extremity Functional Scale

    baseline, post treatment (at 1th week)

Other Outcomes (1)

  • Plantar Fascia Elasticity Measurement

    baseline, post treatment (at 1th week)

Study Arms (3)

ESWT

To the ESWT group, with the ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shock/session values was applied with a 15 mm head in a single session. Shock waves were applied directly to the most sensitive point detected in the medial of the calcaneus.

Placebo ESWT

The placebo ESWT group was given the ESWT device sound recorded from the external audio device and the application was performed without the ESWT device operating.

ESWT+KT

With ESWT device (BTL-6000SWT, UK); Extracorporeal shock wave therapy at 10Hz frequency, 2.5 Barr energy and 2000 shocks/session was applied in a single session with a 15 mm head. Shock waves will be applied directly to the most sensitive point detected in the medial calcaneus, then a tape consisting of 96% cotton and 4% lycra, water-resistant, porous and adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session and the tape will be asked to remain for a week.

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers with a diagnosis of plantar fasciitis and meeting inclusion criteria

You may qualify if:

  • Adult cases aged 18-65 years diagnosed with plantar fasciitis by a physical medicine and rehabilitation specialist,
  • Cases willing to continue the study,
  • In the anamnesis, cases with severe pain when taking the first step after waking up in the morning or after a long period of inactivity and progressive aggravation of the pain as the activity continues,
  • Cases whose consent forms were obtained by being informed about the study.

You may not qualify if:

  • Cases who have undergone foot and ankle surgery,
  • Loss or decrease of sensation in the foot and ankle region for various reasons,
  • Difficulty in communication that prevents treatment and evaluations from being carried out effectively,
  • Pregnancy,
  • Presence of local infection,
  • Having a widespread or regional tumoral disease,
  • Having circulatory disorders in the lower extremities, bleeding,
  • Anticoagulant use,
  • Application of other treatment methods such as cold/hot application, exercise, orthosis use, electrotherapy agents,
  • Cases with a history of systemic, inflammatory, neurological or vascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversitesi

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Hanife Doğan

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR
  • abdulkadir dağbaşı

    Necmettin Erbakan University

    STUDY CHAIR
  • Aynur Başaran

    Karamanoğlu Mehmetbey University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

October 2, 2023

Primary Completion

October 9, 2023

Study Completion

December 4, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations