4 Efficacy

4 Efficacy

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 systematic review of 27 studies, including 3211 patients treated by percutaneous coblation, reported that pain measured on a visual analogue scale (VAS; range 0–10, where 0 is no pain and 10 is the greatest imaginable pain) decreased after percutaneous coblation from 7.27 (n=971) at baseline to 2.84 at 3 months (n=612, p<0.001), 3.03 at 12 months (n=702, p<0.001), and 3.69 at 24 months (n=92, p<0.001). In patients treated by conservative therapy (in the comparator groups of the studies), the mean pain score decreased from 6.98 at baseline (n=98) to 3.85 at 12‑month follow‑up (n=57, p=0.073 compared with percutaneous coblation). A non‑randomised comparative study of 160 patients treated by percutaneous coblation or open discectomy reported that the VAS score for pain reduced from 7.9 and 8.0 at baseline to 2.2 and 1.8, respectively, at 12 month follow‑up (p values not reported).

4.2 A randomised controlled trial (RCT) of 118 patients treated by percutaneous coblation alone, percutaneous coblation combined with nerve root steroid injection, or epidural steroid injection reported that the mean numeric rating scale for pain decreased from 7.15, 7.29 and 7.31 at baseline to 2.27, 2.14 and 3.44, respectively, at 12‑month follow‑up (p<0.001 for all 3 compared with baseline; p<0.001 for percutaneous coblation compared against epidural injection). A case series of 396 patients reported that 75% of patients had at least a 50% improvement in pain after the procedure (mean follow‑up 1 year). A case series of 50 patients reported that 20% (10/50) of patients were asymptomatic after a mean follow‑up of 114 months: 54% of patients had mild pain that could be managed with smaller doses of medication than before the procedure.

4.3 The systematic review of 27 studies reported that functional mobility measured using the Oswestry Disability Index improved after percutaneous coblation from 58.95 (n=318) at baseline to 18.30 at 3 months (n=153, p<0.001), 24.43 at 12 months (n=264, p<0.001) and 36.98 at 24 months (n=92, p<0.005). In the group of patients treated by conservative therapy, the Oswestry Disability Index worsened from 43 at baseline (n=40) to 49 at 12‑month follow‑up (n=28, p<0.001 compared with percutaneous coblation). The non‑randomised comparative study of 160 patients treated by percutaneous coblation or open discectomy reported improvements in disability of 60% and 78%, respectively, at 12‑month follow‑up (p value not reported). The RCT of 118 patients treated by percutaneous coblation alone, percutaneous coblation combined with nerve root steroid injection, or epidural steroid injection reported that the mean Oswestry Disability Index scores decreased from 47.73, 47.71 and 48.10 at baseline to 22.73, 22.85 and 27.76, respectively, at 12 month follow‑up (p<0.001 for all 3 compared with baseline; p<0.001 for percutaneous coblation compared against epidural injection).

4.4 An RCT of 90 patients treated by percutaneous coblation or epidural steroid injection, which was included in the systematic review of 27 studies, reported that both treatments were associated with significant improvements in quality of life measured using the SF‑36 questionnaire: there were significant improvements in components of physical function, bodily pain, the physical components summary, and social function at 6 months. The percutaneous coblation group also had significant improvement for physical and emotional role functioning. There were significant differences between treatment groups in favour of percutaneous coblation for physical function (p=0.0016), bodily pain (p=0.0039), the physical components summary (p=0.004) and social function (p=0.0312).

4.5 The RCT of 90 patients reported that 62% of patients treated by percutaneous coblation were extremely or very satisfied at 6‑month follow‑up compared with 33% of patients treated by epidural steroid injection (absolute numbers and p value not reported). The non‑randomised comparative study of 160 patients reported that 67% of patients would recommend percutaneous coblation to other patients, and 32% of patients would not recommend it.

4.6 A case series of 1390 patients, which was included in the systematic review of 27 studies, reported that disc bulging (visualised on CT or MRI scan) was eliminated in 34% of patients, significantly reduced in 48% and unchanged in 18% of patients at 6‑month follow‑up. An RCT of 64 patients treated by percutaneous coblation or conservative therapy reported a decrease in the mean disc bulge from 5.1 mm at baseline to 1.8 mm at 3‑month follow‑up (p<0.001) in the percutaneous coblation group.

4.7 The specialist advisers listed the key efficacy outcomes as reduction of back and leg pain, disability, and work and domestic productivity.

  • National Institute for Health and Care Excellence (NICE)