Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment

July 31, 2019 updated by: Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital

Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis

A randomized controlled study to search for the efficiency of tibial nerve block vs local corticosteroid injection of the plantar fascia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Three groups will be formed. After ESWT therapy, if the patients still suffer from pain (> 5 points, visual analog scale(0-10points), participants will be included in the study. One group will receive conversational therapy. Second group will be treated with local corticosteroid injection. And third group will be treated with tibial nerve block. Before-treatment, after one week, after six weeks and after 3 months evaluation of the patients will be performed.

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇stanbul
      • Istanbul, İ̇stanbul, Turkey, 34255
        • Recruiting
        • Gaziosmanpasa Taksim Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recalcitrant plantar Fasciitis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recalcitrant Plantar Fasciitis/Conservational
After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients)
Other: Conservational therapy
Only exercise and foot insoles
Experimental: Recalcitrant Plantar Fasciitis/Local
After ESWT therapy patients suffer from extreme pain will receive local steroid injections
Device: Injection
Local corticosteroid injection
Experimental: Recalcitrant Plantar Fasciitis/Tibial nerve
After ESWT therapy patients suffer from extreme pain will receive tibial nerve block
Device: Tibial nerve block
Tibial nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS-Pain
Time Frame: Three months
A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaziosmanpasa Research and Education Hospital

Investigators

  • Study Director: Ebru Yalçınkaya, Gaziosmanpasa Taksim Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

March 30, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

July 20, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREH8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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