title: Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial.
abstract: OBJECTIVE
  To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).
  
  
  METHODS
  Multicentre, blinded, randomised controlled trial.
  
  
  METHODS
  Outpatient multidisciplinary back clinics of five Norwegian hospitals.
  
  
  METHODS
  Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity.
  
  
  METHODS
  Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval.
  
  
  METHODS
  Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain.
  
  
  RESULTS
  Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n = 40), estimated change in the Oswestry disability index from the adjusted baseline value was -4.7 (95% confidence intervals -0.6 to -8.8) at 6 weeks, -11.4 (-6.3 to -14.5) at 12 weeks, and -14.3 (-10.0 to -18.7) at 52 weeks. For the epidural saline intervention group (n = 39) compared with the sham group, differences in primary outcome were -0.5 (-6.3 to 5.4) at 6 weeks, 1.4 (-4.5 to 7.2) at 12 weeks, and -1.9 (-8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were -2.9 (-8.7 to 3.0), 4.0 (-1.9 to 9.9), and 1.9 (-4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend.
  
  
  CONCLUSIONS
  Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy. Trial registration Current Controlled Trials ISRCTN No 12574253.
authors.affiliation: Department of Rehabilitation, University Hospital of North Norway, 9038 Tromsø, Norway.
authors.forename: Trond
authors.initials: T
authors.lastname: Iversen
authors.forename: Tore K
authors.initials: TK
authors.lastname: Solberg
authors.forename: Bertil
authors.initials: B
authors.lastname: Romner
authors.forename: Tom
authors.initials: T
authors.lastname: Wilsgaard
authors.forename: Jos
authors.initials: J
authors.lastname: Twisk
authors.forename: Audny
authors.initials: A
authors.lastname: Anke
authors.forename: Oystein
authors.initials: O
authors.lastname: Nygaard
authors.forename: Toralf
authors.initials: T
authors.lastname: Hasvold
authors.forename: Tor
authors.initials: T
authors.lastname: Ingebrigtsen
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007268:Injections, Epidural; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D010147:Pain Measurement; D011843:Radiculopathy / Q000188:drug therapy*; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000893:Anti-Inflammatory Agents; D014222:Triamcinolone Acetonide