Transarterial Microembolization in Refractory Plantar Fasciitis: Functional and Patient-Reported Early- to Midterm Outcomes from a Single-Center Pilot Study

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

This work represents a rigorous study based on a short series. But strong methodology, clear formulation of the aim, appropriate approaches in outcome assessment and adequate statistics make this study impeccable.

The authors successfully proved conclusions about high potential role of the minimally invasive transarterial microembolization in treatment of selected patients with longstanding plantar fasciitis refractory to conventional therapy.

I would like to congratulate the authors for performing this study and preparing such an interesting article.

There are some suggestions referring to minor revisions

1. A flowchart could be added
2. Line 66-67: misprint – “but” was used twice
3. You could discuss anatomical changes in plantar fascia revealed with imaging (MRI, ultrasonography) at long-term control (18- and/or 24-month milestone) and already reported by other researchers

Author Response

Comment 1 — A flowchart could be added.
We agree. We have added a STROBE-style study flow diagram as the new Figure 1, summarizing patient screening and eligibility assessment (Aug 2023–Dec 2025), the exclusion criteria, inclusion of 13 patients, the 16 transarterial microembolization procedures (including the 3 staged bilateral cases and 1 reintervention, technical success 16/16), and the number of evaluable procedures at each follow-up time point (with a note that reduced later availability was predominantly administrative censoring rather than dropout). The three original figures have been renumbered accordingly (former Figures 1–3 are now Figures 2–4), and a sentence pointing to the flow diagram was added at the start of the Results.

Comment 2 — Line 66–67 misprint: "but" used twice.
Corrected. The phrase "…as a novel concept, but an incremental but clinically relevant extension…" now reads "…as a novel concept, but an incremental yet clinically relevant extension…".

Comment 3 — Discuss anatomical changes in the plantar fascia revealed by imaging (MRI, ultrasonography) at long-term control, already reported by others.
We have added a paragraph to the Discussion. It summarizes that other investigators have documented imaging-detectable anatomical change after treatment — significant reductions in plantar fascia thickness, high-signal-intensity change, and perifascial/bone-marrow edema on MRI after conservative modalities (new ref. 13, Ulusoy et al., J Foot Ankle Surg 2017), and persistent reductions in fascial thickness with morphological/elasticity change on 12-month longitudinal ultrasonography/sonoelastography (new ref. 14, Wu et al., Sci Rep 2020) — and relates this to comparable post-embolization MR imaging change reported in other musculoskeletal indications (existing ref. 3). We note that standardized pre-/post-procedural imaging was not obtained in our cohort and recommend systematic ultrasonography/MRI at the 18- and 24-month milestones in future work. Two references were appended (13, 14); existing citation numbers are unchanged.

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript evaluates transarterial microembolization (TAME) using imipenem/cilastatin for refractory plantar fasciitis in a single-center ambispective observational cohort (13 patients, 16 procedures). The study reports substantial short- and mid-term improvements in pain (NRS), function (FFI), and patient-reported outcomes (PGIC, return to activity), with high technical success and a low complication rate. Benefits appear rapid and sustained up to 12–18 months, with attenuation at 24 months.

Overall, the study addresses a relevant and emerging topic in interventional radiology and musculoskeletal pain management. The manuscript is well written, clinically oriented, and provides useful procedural detail as well as a broad assessment of patient-reported outcomes.

While the study has inherent limitations typical of a small observational cohort, the findings are promising and contribute meaningful early evidence in this evolving field.

 

1. Study design

The study is a single-center observational series without a control group, which is appropriate for an early feasibility experience. As expected in this type of design, conclusions regarding efficacy should be interpreted cautiously and framed as preliminary.

2. Statistical analysis

The statistical methods are generally appropriate for the study design and sample size. Given the observational nature of the study and the small cohort, the analyses should be considered descriptive and exploratory. This is adequately discussed by the authors, although a slightly clearer emphasis on the descriptive nature of the statistical comparisons would improve readability.

3. Outcome measures

The study includes several clinically relevant outcomes, including pain, function, patient global impression, and return to activity. Some outcome measures were adapted for feasibility in this clinical setting (e.g., modified FFI and PGIC scales), which is understandable in a pilot study. It would be helpful to briefly highlight this adaptation in the Discussion and note that it may limit direct comparison with some previous studies.

4. Interpretation of result

The reported improvements in pain and function are encouraging and consistent with previous smaller series in the literature. The authors appropriately compare their findings with existing studies and expand on functional outcomes, which is a useful contribution.

 

This is a well-conducted exploratory study that adds useful preliminary data on transarterial microembolization for refractory plantar fasciitis. While the study design inherently limits definitive conclusions, the results are encouraging and support further research in larger, controlled cohorts.

Author Response

Comment 1 — Study design; conclusions should be framed as preliminary.
We agree. In addition to the existing "exploratory/hypothesis-generating" language in the Abstract and Conclusions, we added an explicit sentence to the opening of the Discussion stating that the observations should be regarded as preliminary and hypothesis-generating given the uncontrolled, single-center design and small sample.

Comment 2 — Statistical analysis; clearer emphasis on the descriptive nature.
We added a sentence to the Statistical Analysis section stating that all reported P values and confidence intervals are presented as descriptive indicators of the magnitude and consistency of the observed within-cohort changes and should not be interpreted as confirmatory hypothesis tests.

Comment 3 — Outcome measures; highlight the FFI/PGIC adaptation in the Discussion and note it limits comparison with previous studies.
We added a sentence to the Discussion noting that the FFI and PGIC were applied in adapted forms (a mean-item 0–10 FFI rather than the original 0–100% summation, and a four-category PGIC), which may limit direct numerical comparison with studies using the original instruments. (This complements the existing limitation already noted in the Methods and Limitations.)

Comment 4 — Interpretation of results.
No change requested; we thank the reviewer for the positive assessment.