Plantar Heel Pain, Plantar FasciosisNCT07884695
Ultrasound-Guided Injections for Plantar Heel Pain
A study testing Ultrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection and Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections in people with Plantar Heel Pain, Plantar Fasciosis and Calcaneal Spur, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study compared three ultrasound-guided injection approaches for patients with plantar heel pain associated with a calcaneal spur: injection around the Baxter nerve, injection at the origin of the flexor digitorum brevis muscle, and a combined injection at both sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Heel Pain, Plantar Fasciosis, Calcaneal Spur
- What is being tested?
- Ultrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection and Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 11 Dec 2024
- 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
- Age ≥18 years.
- Radiographically confirmed calcaneal spur measuring ≥2 mm.
- Plantar heel pain for ≥1 month.
- VAS pain score ≥2.
- Pain at the medial calcaneal tubercle or on palpation of its medial aspect.
- No clinically evident foot deformity.
- No active infection requiring medication during the preceding month.
- No corticosteroid or other injection for symptomatic calcaneal spur within the preceding 6 months.
Who cannot join
- Calcaneal spur measuring <2 mm.
- Bilateral calcaneal spur.
- Known malignancy.
- Chronic kidney disease.
- Drug allergy relevant to the planned injection.
- Lower-extremity peripheral neuropathy.
Show all 10Show fewer
- Active infection requiring treatment.
- Diabetic neuropathy or a necrotic foot wound.
- Previous open or endoscopic surgery for calcaneal spur.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanlıurfa Viranşehir State Hospital
Sanliurfa, Şanliurfa
About this study
Official title: Ultrasound-Guided Baxter Nerve, Flexor Digitorum Brevis, or Combined Injections for Plantar Heel Pain Associated With Calcaneal Spur: A Prospective Randomized Controlled Trial
This study compared three ultrasound-guided injection approaches for patients with plantar heel pain associated with a calcaneal spur: injection around the Baxter nerve, injection at the origin of the flexor digitorum brevis muscle, and a combined injection at both sites. The study assessed pain and foot function before treatment and at 1, 3, and 6 months after treatment to compare the outcomes of the three approaches.
Read the detailed description
This was a prospective, single-center, randomized controlled trial involving 210 patients with plantar heel pain associated with a calcaneal spur. Participants were randomly assigned in a 1:1:1 ratio to one of three ultrasound-guided injection groups: Baxter nerve injection, injection at the origin of the flexor digitorum brevis (FDB) muscle, or combined injections at both sites.
Pain intensity and foot function were assessed at baseline and at 1, 3, and 6 months after treatment using the Visual Analog Scale (VAS) and the Foot Function Index (FFI). The outcomes of the three treatment groups were compared over follow-up.
A total of 202 participants completed follow-up; 8 participants did not attend follow-up. The study aimed to compare clinical outcomes between the three injection approaches in patients with plantar heel pain associated with a calcaneal spur.
- Being tested
- Ultrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection, Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections
- Keywords
- Baxter Nerve, Plantar Fasciitis, Ultrasound-Guided Injection, Flexor Digitorum Brevis, Randomized Controlled Trial
- Medical subject headings
- Heel Spur, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Baxter Nerve InjectionProcedure or surgery
Ultrasound-guided injection targeting the Baxter nerve for plantar heel pain associated with a calcaneal spur. The injection was administered at the Baxter nerve target site.
Ultrasound-Guided Flexor Digitorum Brevis Origin InjectionProcedure or surgery
Ultrasound-guided injection at the origin of the flexor digitorum brevis muscle for plantar heel pain associated with a calcaneal spur.
Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis InjectionsProcedure or surgery
Combined ultrasound-guided injections targeting both the Baxter nerve and the origin of the flexor digitorum brevis muscle for plantar heel pain associated with a calcaneal spur.
| Study group | Role | What they receive |
|---|---|---|
| Baxter Nerve Injection | Experimental | Participants received an ultrasound-guided injection targeting the Baxter nerve, with a total injection volume of 2 mL at the target site. Receives: Procedure: Ultrasound-Guided Baxter Nerve Injection |
| Flexor Digitorum Brevis Injection | Experimental | Participants received an ultrasound-guided injection at the origin of the flexor digitorum brevis muscle, with a total injection volume of 2 mL at the target site. Receives: Procedure: Ultrasound-Guided Flexor Digitorum Brevis Origin Injection |
| Combined Baxter Nerve and Flexor Digitorum Brevis Injections | Experimental | Participants received ultrasound-guided injections at both the Baxter nerve and the origin of the flexor digitorum brevis muscle, with a total injection volume of 1 mL at each site. Receives: Procedure: Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Heel Pain
Change in heel pain intensity measured using the Visual Analog Scale (VAS). Scores were assessed at baseline and at 1, 3, and 6 months after injection.
Measured: Baseline, 1 month, 3 months, and 6 months after injection
Secondary outcomes (1)
Foot Function Index (FFI)
Change in foot-related pain and functional disability measured using the Foot Function Index (FFI). Scores were assessed at baseline and at 1, 3, and 6 months after injection.
Measured: Baseline, 1 month, 3 months, and 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Dec 2023
- Primary completion5 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Heel Pain, Plantar FasciosisStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants were randomly assigned to one of three parallel treatment groups: ultrasound-guided Baxter nerve injection, flexor digitorum brevis origin injection, or combined injections at both sites. Outcomes were assessed at baseline and at 1, 3, and 6 months after treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CENGİZ ARSLAN, MD, Principal investigator, T.C. Ministry of Health Şanlıurfa Viranşehir State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884695
- Sponsor's protocol ID
- 2023-14/07
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Baxter Nerve, Flexor Digitorum Brevis, or Combined Injections for Plantar Heel Pain Associated With Calcaneal Spur: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07884695
- Acronym / sponsor ID
- 2023-14/07
- Keywords
- Baxter Nerve, Plantar Fasciitis, Ultrasound-Guided Injection, Flexor Digitorum Brevis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 20 Oct 2026 (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.
This study compared three ultrasound-guided injection approaches for patients with plantar heel pain associated with a calcaneal spur: injection around the Baxter nerve, injection at the origin of the flexor digitorum brevis muscle, and a combined injection at both sites. The study assessed pain and foot function before treatment and at 1, 3, and 6 months after treatment to compare the outcomes of the three approaches.
Detailed description
This was a prospective, single-center, randomized controlled trial involving 210 patients with plantar heel pain associated with a calcaneal spur. Participants were randomly assigned in a 1:1:1 ratio to one of three ultrasound-guided injection groups: Baxter nerve injection, injection at the origin of the flexor digitorum brevis (FDB) muscle, or combined injections at both sites.
Pain intensity and foot function were assessed at baseline and at 1, 3, and 6 months after treatment using the Visual Analog Scale (VAS) and the Foot Function Index (FFI). The outcomes of the three treatment groups were compared over follow-up.
A total of 202 participants completed follow-up; 8 participants did not attend follow-up. The study aimed to compare clinical outcomes between the three injection approaches in patients with plantar heel pain associated with a calcaneal spur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly assigned to one of three parallel treatment groups: ultrasound-guided Baxter nerve injection, flexor digitorum brevis origin injection, or combined injections at both sites. Outcomes were assessed at baseline and at 1, 3, and 6 months after treatment.
| Arm | Type | Receives |
|---|---|---|
| Baxter Nerve Injection | Experimental | Procedure: Ultrasound-Guided Baxter Nerve InjectionParticipants received an ultrasound-guided injection targeting the Baxter nerve, with a total injection volume of 2 mL at the target site. |
| Flexor Digitorum Brevis Injection | Experimental | Procedure: Ultrasound-Guided Flexor Digitorum Brevis Origin InjectionParticipants received an ultrasound-guided injection at the origin of the flexor digitorum brevis muscle, with a total injection volume of 2 mL at the target site. |
| Combined Baxter Nerve and Flexor Digitorum Brevis Injections | Experimental | Procedure: Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis InjectionsParticipants received ultrasound-guided injections at both the Baxter nerve and the origin of the flexor digitorum brevis muscle, with a total injection volume of 1 mL at each site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Radiographically confirmed calcaneal spur measuring ≥2 mm.
- Plantar heel pain for ≥1 month.
- VAS pain score ≥2.
- Pain at the medial calcaneal tubercle or on palpation of its medial aspect.
Key exclusion criteria (10 listed)
- Calcaneal spur measuring <2 mm.
- Bilateral calcaneal spur.
- Known malignancy.
- Chronic kidney disease.
- Drug allergy relevant to the planned injection.
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 |
|---|---|---|
| Ultrasound-Guided Baxter Nerve InjectionUltrasound-guided injection targeting the Baxter nerve for plantar heel pain associated with a calcaneal spur. The injection was administered at the Baxter nerve target site. | Procedure or surgery | Baxter Nerve Injection |
| Ultrasound-Guided Flexor Digitorum Brevis Origin InjectionUltrasound-guided injection at the origin of the flexor digitorum brevis muscle for plantar heel pain associated with a calcaneal spur. | Procedure or surgery | Flexor Digitorum Brevis Injection |
| Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis InjectionsCombined ultrasound-guided injections targeting both the Baxter nerve and the origin of the flexor digitorum brevis muscle for plantar heel pain associated with a calcaneal spur. | Procedure or surgery | Combined Baxter Nerve and Flexor Digitorum Brevis Injections |
Primary outcome
Visual Analog Scale (VAS) for Heel Pain
Time frame: Baseline, 1 month, 3 months, and 6 months after injection
Change in heel pain intensity measured using the Visual Analog Scale (VAS). Scores were assessed at baseline and at 1, 3, and 6 months after injection.
1 secondary outcome
Foot Function Index (FFI)
Time frame: Baseline, 1 month, 3 months, and 6 months after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Plantar Heel Pain, Plantar Fasciosis
Not yet recruiting
Calcaneal Osteotomy for Recalcitrant Planter Fasciosis
Plantar Fascitis
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.
CENGİZ ARSLAN, MD principal investigator
T.C. Ministry of Health Şanlıurfa Viranşehir State 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 Ultrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection and Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections in people with Plantar Heel Pain, Plantar Fasciosis and Calcaneal Spur, run by Kutahya Health Sciences University 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 20 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Heel Pain (time frame: Baseline, 1 month, 3 months, and 6 months after injection). 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 20 Oct 2026.