This section describes safety 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.
5.1 Increased radicular pain was reported in 2% (1/45) of patients treated by percutaneous coblation and 13% (5/40) of patients treated by epidural steroid injection in a randomised controlled trial (RCT) of 90 patients; increased back pain was reported in 2% (1/45) and 10% (4/40) of patients respectively. Acute low back pain with spasms was reported in 1 patient in each group in the same study. Lateralised postural lumbar pain and hypertone (contraction of paravertebral muscles), which lasted up to 10 days after the procedure, were reported in 5% of patients in a case series of 1390 patients (actual numbers not reported). Worsening of pain was reported in 1 patient in a case series of 396 patients.
5.2 Muscle tightness or spasms were reported in 4% (2/45) of patients treated by percutaneous coblation and 3% (1/40) of patients treated by epidural steroid injection in the RCT of 90 patients.
5.3 Bradycardia, reported by the authors as being related to poor tolerance to minor pain, was reported in 1% (4/396) of patients in the case series of 396 patients.
5.4 Discitis was reported in 1 patient in the case series of 396 patients (no further information given).
5.5 Radicular paraesthesia was reported in less than 1% (2/396) of patients in the case series of 396 patients.
5.6 Increased weakness was reported in 2% (1/45) of patients treated by percutaneous coblation and 0% (0/40) of patients treated by epidural steroid injection in the randomised controlled trial of 90 patients.
5.7 Epidural fibrosis, diagnosed by MRI 3 months after percutaneous coblation, was reported in a single case report. The patient had recurrence of pain in the left lower extremity and lower back, which spontaneously resolved after the MRI. No further treatment was needed.
5.8 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed visceral injury and vascular injury as anecdotal adverse events. They considered that the following were theoretical adverse events: nerve injury, needle misplacement through the disc to the retroperitoneum or behind the dura or spinal canal, instability, paralysis, bleeding, and possibly late disc protrusion (rare).