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Ultrasound-Guided Injections for Plantar Heel Pain

NCT07884695 — Not applicable, Completed, 210 participants, Kutahya Health Sciences University

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Ultrasound-Guided Baxter Nerve, Flexor Digitorum Brevis, or Combined Injections for Plantar Heel Pain Associated With Calcaneal Spur: A Prospective Randomized Controlled Trial

RegistryNCT07884695
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment210 (Actual)
SponsorKutahya Health Sciences University (Other)
ConditionsPlantar Heel Pain, Plantar Fasciosis, Calcaneal Spur
InterventionsUltrasound-Guided Baxter Nerve Injection, Ultrasound-Guided Flexor Digitorum Brevis Origin Injection, Combined Ultrasound-Guided Baxter Nerve and Flexor Digitorum Brevis Injections (Procedure)
Datesstart 2023-12-15, primary completion 2024-12-05, completion 2024-12-11, first posted 2026-10-20, last updated 2026-10-20
Locations1 site in Turkey (Türkiye)

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-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. 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Baxter Nerve InjectionExperimentalProcedure: 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 InjectionExperimentalProcedure: 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 InjectionsExperimentalProcedure: 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.
  • Ultrasound-Guided Baxter Nerve Injection (Procedure): 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 Injection (Procedure): 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 Injections (Procedure): 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.

+Outcome measures

Primary outcomes

  • Visual Analog Scale (VAS) for Heel Pain [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.

Secondary outcomes

  • Foot Function Index (FFI) [Baseline, 1 month, 3 months, and 6 months after injection]: 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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Şanlıurfa Viranşehir State HospitalSanliurfa, ŞanliurfaTurkey (Türkiye)

+Investigators

  • CENGİZ ARSLAN, MD, Principal investigator, T.C. Ministry of Health Şanlıurfa Viranşehir State Hospital

My Notes