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    Efficacy summary

    Pain relief

    In a case series of 20 patients with Morton's neuroma, the mean pain score measured on a VAS from 0 to 10 (higher scores indicating worse pain) was 3.0 after a mean follow up of 19.7 months (Cazzato 2016).

    In a case series of 21 patients with refractory phantom limb pain (including 13 with an identified neuroma), the mean pain score reduced from 6.2 (95% CI 5.2 to 7.3) before treatment to 5.4 (95% CI 4.2 to 6.6; p=not significant) at 7 days, 2.3 (95% CI 1.6 to 3.0; p<0.0001) at 45 days and 2.0 (95% CI 0.9 to 3.0; p<0.0001) at last follow up (mean 194 days; Prologo 2017).

    In a case series of 7 patients with a symptomatic stump neuroma after limb amputation, the mean pain score reduced from 8.3 before treatment to 2.1 at 1 week (p=0.004) after treatment and 3 at last follow up (mean 27 months; p=0.004). There was no correlation of pain decrease with patient age, duration of pain before ablation or time interval between amputation and ablation (von Falck 2022).

    In a case series of 22 patients with refractory peripheral neuropathic pain (3 with plantar neuromas), the mean pain score reduced from 8.3 before treatment to 2.3 at 1 month (p=0.0001), 3.2 at 3 months (p=0.0002), 4.7 at 6 months (p=0.002) and 5.1 at 12 months (p=0.03). The mean time to pain recurrence was 9.3 months (Yoon J 2016).

    In a case series of 20 patients with painful neuromas or peripheral neuritis, 75% (15/20) of people had some pain relief after the treatment. Of these 15 patients, 11 had marked or total pain relief, 3 had moderate relief and 1 had mild relief (Friedman 2012).

    Functional score

    In the case series of 21 patients with refractory phantom limb pain, the mean functional score (range 0 to 24) improved from 11.3 (95% CI 8.8 to 13.9) before treatment to 9.4 (95% CI 7.3 to 11.5; p=not significant) at 7 days and 3.3 (95% CI 2.2 to 4.4; p<0.001) at 45 days follow up (Prologo 2017).

    Patient satisfaction

    In the case series of 20 patients with Morton's neuroma, complete satisfaction was reported for 78% (14/18) of neuromas, and satisfaction with minor reservations was reported for 17% (3/18) of neuromas, after a mean follow up of 19.7 months. None of the patients reported that they were dissatisfied (Cazzato 2016).

    In the case series of 7 patients with a symptomatic stump neuroma after limb amputation, the mean satisfaction score was 69% (range 10 to 100%) at last follow up (mean 27 months). Of the 7 patients, 1 was not satisfied with the treatment outcome and reported that they would not be willing to have the procedure again (von Falck 2022).

    Technical success

    In the case series of 20 patients with Morton's neuroma and the case series of 7 patients with a symptomatic stump neuroma after limb amputation, technical success was 100% (Cazzato 2016, von Falck 2022).

    Repeat procedures

    In the case series of 21 patients with refractory phantom limb pain, 4 had a second cryoablation treatment, all of which were technically successful. Pain intensity scores decreased by a mean of 4.25 points (p=0.0013) compared with baseline of the first procedure after a mean follow up of 165 days (Prologo 2017).

    In the case series of 22 patients with refractory peripheral neuropathic pain, 1 patient had repeat cryoablation within the first month, 2 had repeat cryoablation at 3 months, 3 at 6 months, 6 at 12 months and 5 people had repeat cryoablation between 13 and 18 months after the initial procedure. One person chose to have a neurectomy 9 months after the cryoablation procedure (Yoon 2016).