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 non-randomised comparative study of 98 patients compared treatment by endoscopic adhesiolysis, foraminoplasty and discectomy (n=78) with endoscopic adhesiolysis and foraminoplasty without discectomy (n=20). Visual analogue scale (VAS) scores (ranging from 0–10, with lower scores indicating less pain) for radicular pain improved from 7.6 to 3.6 with discectomy and from 8.5 to 6.1 without discectomy at final follow-up (p values not reported; mean follow-up periods were 21 and 23 months respectively). A non-randomised comparative study of 57 patients compared treatment by endoscopic adhesiolysis, foraminoplasty and discectomy (n=32) with endoscopic adhesiolysis and foraminoplasty without discectomy (n=25). The improvement in VAS score for low back pain was statistically significant with discectomy (from 8.1 to 4.4; p=0.01) but not without discectomy (from 8.5 to 6.7; p=0.12) at 24-month follow-up. The difference between the groups was statistically significant (p<0.01). In the same study, improvements in VAS scores for leg pain were not statistically significant (from 6.2 to 4.7; p=0.07 and from 6.7 to 5.2; p=0.15, respectively) at 24-month follow-up. The difference between the groups was statistically significant (p=0.05). In a case series of 154 patients, there was a statistically significant decrease in VAS score for pain from 7.5 at baseline to 3.4 at follow-up (p<0.005). In a case series of 250 patients, the mean VAS score for leg pain decreased from 7.1 at baseline to 2.6 (p<0.01) and the mean VAS score for back pain decreased from 5.9 at baseline to 2.7 (p<0.01) at 3-month follow-up.

4.2 In the non-randomised comparative study of 98 patients, Roland Morris disability questionnaire scores (ranging from 0–24, with lower scores indicating less disability) changed from 18.8 to 10.6 with discectomy and from 11.3 to 11.4 without discectomy at final follow-up (p values not reported; mean follow-up periods were 21 and 23 months respectively). In the non-randomised comparative study of 57 patients, the change in Roland Morris disability questionnaire scores was statistically significant with discectomy (from 13.2 to 8.5; p=0.03) but not without discectomy (from 12.6 to 10.4; p=0.09) at 24-month follow-up. The difference between the groups was statistically significant (p<0.01). In the case series of 154 patients, the change in Roland Morris disability questionnaire score was statistically significant, from 18.1 at baseline to 10.3 at follow-up (p<0.005). In the case series of 250 patients, the Oswestry Disability Index score (ranging from 0–100) improved from 50 at baseline to 12 at 3-month follow-up (p<0.01).

4.3 The specialist advisers listed key efficacy outcomes as relief of back or leg pain, improvement in patient-reported outcome measures (such as Oswestry Disability Index), reduced length of hospital stay and reduced time off work.

  • National Institute for Health and Care Excellence (NICE)