Plantar FascitisNCT04029389
Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment
A study testing Injection, Tibial nerve block and Conservational therapy in people with Plantar Fascitis and Tibial Nerve, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled study to search for the efficiency of tibial nerve block vs local corticosteroid injection of the plantar fascia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fascitis, Tibial Nerve, Injections
- What is being tested?
- Injection, Tibial nerve block and Conservational therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recalcitrant plantar Fasciitis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Zeynel Karakullukcuoglu, M.D. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Taksim Training and Research Hospital
Istanbul, İ̇stanbul, 34255
Mehmet Akif Guler, 5054930098, makifguler89@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
- Being tested
- Injection, Tibial nerve block, Conservational therapy
- Keywords
- Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionDevice
Local corticosteroid injection
Tibial nerve blockDevice
Tibial nerve block
Conservational therapyOther
Only exercise and foot insoles
| Study group | Role | What they receive |
|---|---|---|
| Recalcitrant Plantar Fasciitis/Conservational | Experimental | After ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients) Receives: Other: Conservational therapy |
| Recalcitrant Plantar Fasciitis/Local | Experimental | After ESWT therapy patients suffer from extreme pain will receive local steroid injections Receives: Device: Injection |
| Recalcitrant Plantar Fasciitis/Tibial nerve | Experimental | After ESWT therapy patients suffer from extreme pain will receive tibial nerve block Receives: Device: Tibial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-Pain
A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Akif GÜLER, Gaziosmanpasa Research and Education Hospital
- Investigators
- Ebru Yalçınkaya, Study director, Gaziosmanpasa Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029389
- Sponsor's protocol ID
- GaziosmanpasaTREH8
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT04029389
- Acronym / sponsor ID
- GaziosmanpasaTREH8
- Conditions
- Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
- Keywords
- Plantar Fascitis, Tibial Nerve, Injections, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recalcitrant Plantar Fasciitis/Conservational | Experimental | Other: Conservational therapyAfter ESWT therapy patients suffer from extreme pain will recieve only conservational therapy (26 patients) |
| Recalcitrant Plantar Fasciitis/Local | Experimental | Device: InjectionAfter ESWT therapy patients suffer from extreme pain will receive local steroid injections |
| Recalcitrant Plantar Fasciitis/Tibial nerve | Experimental | Device: Tibial nerve blockAfter ESWT therapy patients suffer from extreme pain will receive tibial nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recalcitrant plantar Fasciitis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InjectionLocal corticosteroid injection | Device | Recalcitrant Plantar Fasciitis/Local |
| Tibial nerve blockTibial nerve block | Device | Recalcitrant Plantar Fasciitis/Tibial nerve |
| Conservational therapyOnly exercise and foot insoles | Other | Recalcitrant Plantar Fasciitis/Conservational |
Primary outcome
VAS-Pain
Time frame: Three months
A scale on 0-10 points. 0 points indicate no pain, and 10 points show worst pain ever
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynel Karakullukcuoglu, M.D. contact
Ebru Yalçınkaya study director
Gaziosmanpasa Taksim Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection, Tibial nerve block and Conservational therapy in people with Plantar Fascitis and Tibial Nerve, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Akif A Guler, M.D. (+905054930098, makifguler89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS-Pain (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.