Effect of caudal epidural steroid or saline injection in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trialBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5278 (Published 13 September 2011) Cite this as: BMJ 2011;343:d5278
- Trond Iversen, consultant15,
- Tore K Solberg, consultant23,
- Bertil Romner, professor4,
- Tom Wilsgaard, assistant professor5,
- Jos Twisk, professor6,
- Audny Anke, assistant professor17,
- Øystein Nygaard, professor38,
- Toralf Hasvold, professor5,
- Tor Ingebrigtsen, professor7
- 1Department of Rehabilitation, University Hospital of North Norway, 9038 Tromsø, Norway
- 2Department of Neurosurgery, University Hospital of North Norway
- 3Norwegian Registry for Spine Surgery, North Norway Regional Health Authority, Tromsø
- 4Neuroscience Centre, Department of Neurosurgery, Rigshospitalet, Copenhagen, Denmark
- 5Faculty of Health Sciences, Department of Community Medicine, University of Tromsø, Tromsø
- 6VU University Medical Centre, Amsterdam, Netherlands
- 7Faculty of Health Sciences, Institute of Clinical Medicine, Tromsø
- 8Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
- Correspondence to: T Iversen
- Accepted 17 July 2011
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).
Design Multicentre, blinded, randomised controlled trial.
Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals.
Participants 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.
Interventions 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.
Main outcome measures 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.
We thank Jan Inge Letto, Anne Sofie Broback, Dag Grindheim, Robert Kouwenhoven, Fredrik Granviken, Franz Hintringer, Svetlana Rasic, Helge Hartman, Sigrun Randen, and Einar Vegå for doing the assessments; Olaf Sivertsen, Just Thoner, Jørgen Hansen, Gunnar Engesnes, Niels Becker, and Tarjei Rygnestad for doing the epidural injections; the Clinical Research Centre at the University Hospital of North Norway, Bjørn Odvar Eriksen, Inger Sperstad, May Greta Pedersen, Sameline Grimsgaard, Dag Grønvoll, Aslaug Jakobsen, Rolf Salvesen, Dagfinn Thorsvik, Tormod Hagen, Bjørn Skogstad, Therese Norberg Hanvold, and all the patients who participated in this study; and Bjørn Aske of Medinor Norway for lending us the Honda Ultrasound machines.
Contributors: TIversen contributed to the study design, data collection, data analysis, interpretation, and writing of the manuscript. TS, ØN, TIngebrigtsen, TW, AA, and BR contributed to the study design, data analysis, interpretation, and writing of the manuscript. TH contributed to the study design. JT contributed to data analysis and interpretation. Data verification was undertaken by the Clinical Research Centre at the University Hospital of North Norway.
Funding: The study was supported by the North Norway Regional Health Authority and Health Region Nord-Trøndelag, Norway.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: this study was supported by the North Norway Regional Health Authority and Health Region Nord-Trøndelag; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study protocol was approved by the ethics committee for Medical Research Region 5 Norway.
Data sharing: Technical appendix, statistical code, and dataset are available from the corresponding author.
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