NCT04029389

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

July 20, 2019

Last Update Submit

July 31, 2019

Conditions

Plantar FascitisTibial NerveInjectionsUltrasonography

Keywords

Plantar FascitisTibial NerveInjectionsUltrasonography

Outcome Measures

Primary Outcomes (1)

  • VAS-Pain

    A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever

    Three months

Study Arms (3)

Recalcitrant Plantar Fasciitis/Conservational

EXPERIMENTAL

After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients)

Other: Conservational therapy

Recalcitrant Plantar Fasciitis/Local

EXPERIMENTAL

After ESWT therapy patients suffer from extreme pain will receive local steroid injections

Device: Injection

Recalcitrant Plantar Fasciitis/Tibial nerve

EXPERIMENTAL

After ESWT therapy patients suffer from extreme pain will receive tibial nerve block

Device: Tibial nerve block

Interventions

InjectionDEVICE

Local corticosteroid injection

Recalcitrant Plantar Fasciitis/Local
Tibial nerve blockDEVICE

Tibial nerve block

Recalcitrant Plantar Fasciitis/Tibial nerve
Conservational therapyOTHER

Only exercise and foot insoles

Recalcitrant Plantar Fasciitis/Conservational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recalcitrant plantar Fasciitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Taksim Training and Research Hospital

Istanbul, İ̇stanbul, 34255, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ebru Yalçınkaya

    Gaziosmanpasa Taksim Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Mehmet Akif A Guler, M.D.

CONTACT

+905054930098makifguler89@gmail.com

Zeynel Karakullukcuoglu, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2019

First Posted

July 23, 2019

Study Start

July 1, 2019

Primary Completion

March 30, 2020

Study Completion

June 30, 2020

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)