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    Efficacy summary

    Pain reduction

    In a prospective pilot study of 16 patients with painful spinal metastases treated with RFA alone (n=8) or RFA plus cement augmentation (n=8), pain decreased significantly after treatment (RFA alone group: from mean baseline VAS 7.6 to 5.5, p=0.018; RFA plus cement augmentation group: from mean baseline VAS 7.9 to 5.0, p=0.005) and between 15 and 36 months follow up in both the groups respectively (RFA group: 7.6 to 4.0, p<0.008; RFA plus cement augmentation group: 7.9 to 3.5, p<0.005) (Proschek 2009).

    In a small prospective study of 10 patients with spinal metastases who had RFA alone (in 4) or RFA plus cement augmentation (in 6), mean VAS score decreased from baseline 4.3 to 1.7 (p=0.0004) in the RFA alone group and from 6.6 to 1.7 (p=0.003) in the RFA plus cement augmentation group at 1 week follow up (Nakatsuka 2009).

    In a retrospective analysis of 66 patients with painful vertebral metastases (26 treated with RFA alone and 40 treated with RFA plus vertebroplasty), the mean VAS scores significantly changed at all follow-up periods compared to baseline in both the groups (in the RFA alone group, scores changed from 8.3±1.07 at baseline to 4.8±1.03 at day 1, 3.67±1,07 at 1 month, 4.50±1.57 at 3 months and 4.42±1.08 at 6 months; p<0.001 for all time points; in the RFA plus vertebroplasty group, scores changed from 7.44±1.06 at baseline to 4.38±1.00 at day 1, 2.94±1.04 at 1 month, 2.44±1.61 at 3 months and 2.31±1.42 at 6 months; p<0.001 at all time points). The pain scores decreased at a rate of 59% in the RFA alone group and 83% in the RFA plus vertebroplasty group (Yildizhan 2021).

    In a prospective cohort study of 36 patients treated with bipolar RFA alone for palliation of pain in advanced tumours near the spine and adjacent to neurological structures, pain relief was reported in 53% of cases (Gazis 2004).

    Progression or recurrence of vertebral metastases

    The prospective pilot study of 16 patients reported that none of the patients had a local recurrence after treatment with RFA alone or RFA in combination with vertebroplasty (Proschek 2009).

    Health-related quality of life (HRQoL)

    In the pilot study of 16 patients, 8 who had RFA alone and 8 who had RFA plus vertebroplasty reported improved quality of life (mean ODI scores improved from 64% at baseline to 33%, p=0.06 at 3 to 6 months follow up in RFA group; and from 66% at baseline to 35%, p=0.071 at 15 to 36 months follow up in RFA plus vertebroplasty group) (Proschek 2009).

    In the retrospective analysis of 66 patients with painful vertebral metastasis (26 treated with RFA alone and 40 treated with RFA plus vertebroplasty), mean ODI scores significantly changed at all follow-up periods compared to baseline in both groups (in the RFA alone group, scores changed from 79% at baseline to 66% at day 1, 62% at 1 month, 55% at 3 months and 30% at 6 months; p<0.001 for all time points; in the RFA plus vertebroplasty group, scores changed from 79% at baseline to 56% at day 1, 45% at 1 month, 40% at 3 months and 14% at 6 months; p<0.001 at all time points). Seventy per cent of patients in the RFA alone group and 53% of patients in the RFA plus vertebroplasty group showed significant improvements in quality of life (Yildizhan 2021).