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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029389
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital

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

Condition or disease Intervention/treatment Phase
Plantar Fascitis Tibial Nerve Injections Ultrasonography Device: Injection Device: Tibial nerve block Other: Conservational therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Ultrasound

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




Primary Outcome Measures :
  1. VAS-Pain [ Time Frame: Three months ]
    A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recalcitrant plantar Fasciitis

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029389


Contacts
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Contact: Mehmet Akif A Guler, M.D. +905054930098 makifguler89@gmail.com
Contact: Zeynel Karakullukcuoglu, M.D.

Locations
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Turkey
Gaziosmanpasa Taksim Training and Research Hospital Recruiting
Istanbul, İ̇stanbul, Turkey, 34255
Contact: Mehmet Akif Guler    5054930098    makifguler89@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
Investigators
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Study Director: Ebru Yalçınkaya Gaziosmanpasa Taksim Training and Research Hospital

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Responsible Party: Mehmet Akif GÜLER, Principal Investigator, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT04029389    
Other Study ID Numbers: GaziosmanpasaTREH8
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Akif GÜLER, Gaziosmanpasa Taksim Research and Education Hospital:
Plantar Fascitis
Tibial Nerve
Injections
Ultrasonography
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases