Ultrasound-Guided Baxter Nerve, Flexor Digitorum Brevis, or Combined Injections for Plantar Heel Pain Associated With Calcaneal Spur: A Prospective Randomized Controlled Trial
| Registry | NCT07884695 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 210 (Actual) |
| Sponsor | Kutahya Health Sciences University (Other) |
| Conditions | Plantar Heel Pain, Plantar Fasciosis, Calcaneal Spur |
| Interventions | Ultrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection, Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections (Procedure) |
| Dates | start 2023-12-15, primary completion 2024-12-05, completion 2024-12-11, first posted 2026-10-20, last updated 2026-10-20 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Plantar Heel Pain, Plantar Fasciosis All trials for Calcaneal Spur All trials of Ultrasound-Guided Baxter Nerve Injection All trials of Ultrasound-Guided Flexor Digitorum Brevis Origin Injection
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Baxter Nerve Injection | Experimental | Procedure: Ultrasound-Guided Baxter Nerve Injection | Participants 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 Injection | 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. |
| Combined Baxter Nerve and Flexor Digitorum Brevis Injections | Experimental | Procedure: Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * Calcaneal spur measuring <2 mm. * Bilateral calcaneal spur. * Known malignancy. * Chronic kidney disease. * Drug allergy relevant to the planned injection. * Lower-extremity peripheral neuropathy. * Active infection requiring treatment. * Diabetic neuropathy or a necrotic foot wound. * Previous open or endoscopic surgery for calcaneal spur. * Pregnancy or breastfeeding.
| Facility | City | Country | Status |
|---|---|---|---|
| Şanlıurfa Viranşehir State Hospital | Sanliurfa, Şanliurfa | Turkey (Türkiye) |