This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A case series of 25 patients (30 feet) with symptomatic interdigital (Morton's) neuroma reported a statistically significant reduction in pain scores on activity after ultrasound‑guided radiofrequency ablation (RFA) treatment. Pain scores were measured on a visual analogue scale (assessed on a scale of 0–10, with lower scores indicating less pain) and were an average of 6.0 at baseline compared with 1.7 at 6‑month follow‑up (p<0.001). A case series of 37 patients (38 neuromas) for whom conservative management failed and who had RFA, reported median numerical pain scores (assessed on a scale of 0–10, with lower scores indicating less pain). Pain scores decreased significantly from 9.0 at baseline to 5.0 at an average follow‑up of 10.6 months (p value not reported).
4.2 The case series of 25 patients reported that the average overall symptom improvement (as described by patients, not otherwise defined) was 76%. The case series of 37 patients (38 neuromas) reported that for 74% of neuromas there was complete or partial resolution of symptoms and for 26% there was no benefit at an average follow‑up of 10.6 months. All patients with neuromas in the third web space (n=18) reported complete or partial relief of symptoms compared with only 50% of those with second web space neuromas (n=20).
4.3 The case series of 37 patients reported that 87% (32/37) of patients were satisfied with RFA treatment at an average follow‑up of 10.6 months. Most patients (84%) said that they would have the procedure again.
4.4 The case series of 37 patients reported that 2 patients with no symptom relief had repeat RFA treatment but were not satisfied with the outcome at an average follow‑up of 10.6 months.
4.5 A case series of 29 patients (with 32 neuromas treated) reported symptom recurrence in 1 patient at 9‑month follow‑up. This was successfully treated with an injection of steroid and local anaesthetic.
4.6 Progression to surgical removal of the neuromas was reported for 29% (11/38) of neuromas (3 neuromas in patients with partial symptom relief and 8 neuromas in patients with no symptom relief) in the case series of 37 patients (38 neuromas) at an average follow‑up of 10.6 months. Of the patients who had surgical removal, 6 patients had complete relief of symptoms, 3 had partial relief, 1 had no change in symptoms and 1 got worse. The average numerical pain score decreased from 6.9 to 2.7 (p value not reported).
4.7 The specialist advisers listed key efficacy outcomes as relief or reduction of pain and avoiding the need for surgery.