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 In a systematic review of 17 studies that included patients treated by Intradiscal Electrothermal Therapy (IDET), 13 studies (503 patients) reported visual analogue scale scores for pain (scores ranged from 0 to 10 with lower scores indicating less pain). Meta‑analysis revealed that visual analogue scale scores for pain improved by a mean of 2.9 points (95% confidence interval [CI] 2.5 to 3.4; no p value reported). Meta‑analysis of 4 studies (n=196 patients) that reported SF‑36 bodily pain scores (scores ranged from 0 to 100 with higher scores indicating less pain) showed that scores improved by a mean of 21.1 points (95% CI 13.4 to 28.8; no p value reported).

4.2 In a randomised controlled trial of 59 patients treated by intradiscal biacuplasty (n=29) or sham (n=30), mean numerical rating scale scores for pain (scores ranged from 0 to 10 with lower scores indicating less pain) improved from 7.13 to 4.94 and from 7.18 to 6.58 respectively, at 6‑month follow‑up (p value between groups=0.014).

4.3 In a non‑randomised comparative study of 46 patients treated by Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT) of the annulus (n=31) or conservative treatment (n=15), mean visual analogue scale scores for pain (scores ranged from 0 to 10 with lower scores indicating less pain) changed from 7.2 to 4.5 (p<0.001) and from 6.2 to 6.3 (not significant) respectively, at 1‑year follow‑up. No p value for inter‑group comparisons was reported.

4.4 In the systematic review of 17 studies that included patients treated by IDET, 3 studies (79 patients) reported Oswestry Disability Index (ODI) scores (scores ranged from 0 to 100 with lower scores indicating less disability). Meta‑analysis showed that ODI scores improved by a mean of 7.0 points (95% CI 2.0 to 11.9; no p value reported).

4.5 In the randomised controlled trial of 59 patients treated by intradiscal biacuplasty (n=29) or sham (n=30), mean ODI scores changed from 40.37 to 32.94 and from 40.93 to 41.17 respectively, at 6‑month follow‑up (p value between groups=0.005).

4.6 In the non‑randomised comparative study of 46 patients treated by PIRFT of the annulus (n=31) or conservative treatment (n=15), mean ODI scores improved from 48.1 to 35.5 (p<0.001) and from 46.1 to 46.0 (not significant) respectively, at 1‑year follow‑up. No p value for inter‑group comparisons was reported.

4.7 In the systematic review of 17 studies that included patients treated by IDET, 4 studies (196 patients) reported SF‑36 physical function scores (scores ranged from 0 to 100 with higher scores indicating better physical function). Meta‑analysis showed that scores improved by a mean of 18.0 points (95% CI 11.9 to 24.1; no p value reported).

4.8 In the randomised controlled trial of 59 patients treated by intradiscal biacuplasty (n=29) or sham (n=30), mean SF‑36 physical function scores changed from 47.04 to 62.04 and from 46.03 to 48.67 respectively, at 6‑month follow‑up (p value between groups=0.012).

4.9 In the randomised controlled trial of 59 patients treated by intradiscal biacuplasty (n=29) or sham (n=30), mean amount of opioids taken each day changed from 52.47 mg to 36.87 mg and from 50.85 mg to 49.48 mg respectively, at 6‑month follow‑up (not significant).

4.10 Specialist advisers listed key efficacy outcomes as visual analogue scale scores for pain, validated back pain and disability scores, functional outcome scores and measures of social function (for example, productivity at home and the ability to work).

  • National Institute for Health and Care Excellence (NICE)