Back to resultsUltrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment
Primary Purpose
Plantar Fascitis, Tibial Nerve, Injections
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Injection
Tibial nerve block
Conservational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fascitis focused on measuring Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
Eligibility Criteria
Inclusion Criteria:
- Recalcitrant plantar Fasciitis
Exclusion Criteria:
-
Sites / Locations
- Gaziosmanpasa Taksim Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Recalcitrant Plantar Fasciitis/Conservational
Recalcitrant Plantar Fasciitis/Local
Recalcitrant Plantar Fasciitis/Tibial nerve
Arm Description
After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients)
After ESWT therapy patients suffer from extreme pain will receive local steroid injections
After ESWT therapy patients suffer from extreme pain will receive tibial nerve block
Outcomes
Primary Outcome Measures
VAS-Pain
A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever
Secondary Outcome Measures
Full Information
NCT ID
NCT04029389
First Posted
July 20, 2019
Last Updated
July 31, 2019
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04029389
Brief Title
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment
Official Title
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized controlled study to search for the efficiency of tibial nerve block vs local corticosteroid injection of the plantar fascia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
Keywords
Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recalcitrant Plantar Fasciitis/Conservational
Arm Type
Experimental
Arm Description
After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients)
Arm Title
Recalcitrant Plantar Fasciitis/Local
Arm Type
Experimental
Arm Description
After ESWT therapy patients suffer from extreme pain will receive local steroid injections
Arm Title
Recalcitrant Plantar Fasciitis/Tibial nerve
Arm Type
Experimental
Arm Description
After ESWT therapy patients suffer from extreme pain will receive tibial nerve block
Intervention Type
Device
Intervention Name(s)
Injection
Intervention Description
Local corticosteroid injection
Intervention Type
Device
Intervention Name(s)
Tibial nerve block
Intervention Description
Tibial nerve block
Intervention Type
Other
Intervention Name(s)
Conservational therapy
Intervention Description
Only exercise and foot insoles
Primary Outcome Measure Information:
Title
VAS-Pain
Description
A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recalcitrant plantar Fasciitis
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Akif A Guler, M.D.
Phone
+905054930098
Email
makifguler89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynel Karakullukcuoglu, M.D.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Yalçınkaya
Organizational Affiliation
Gaziosmanpasa Taksim Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Gaziosmanpasa Taksim Training and Research Hospital
City
Istanbul
State/Province
İ̇stanbul
ZIP/Postal Code
34255
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Guler
Phone
5054930098
Email
makifguler89@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment
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