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Randomized Controlled Trial
. 2024 Apr 1;25(1):247.
doi: 10.1186/s12891-024-07366-5.

Cost-effectiveness of Transforaminal epidural steroid injections for patients with ACUTE sciatica: a randomized controlled trial

Bastiaan C Ter Meulen  1   2 , Esther T Maas  3 , Rien van der Vegt  4 , Johan Haumann  5 , Henry C Weinstein  6 , Raymond W J G Ostelo  3   7 , Johanna M van Dongen  3
Affiliations
Randomized Controlled Trial

Cost-effectiveness of Transforaminal epidural steroid injections for patients with ACUTE sciatica: a randomized controlled trial

Bastiaan C Ter Meulen et al. BMC Musculoskelet Disord. .

Abstract

Background: Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial.

Methods: Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty.

Results: None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures.

Conclusion: These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting.

Trial registration: Dutch National trial register: NTR4457 (March, 6th, 2014).

Keywords: Economic evaluation; Lumbar disc herniation; Randomized controlled trial; Sciatica; Transforaminal epidural steroid injections.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
STAR-trial: enrolment, randomization and follow-up
Fig. 2
Fig. 2
Cost-effectiveness acceptability curve indicating the probability of the intervention conditions’ being cost-effectiveness compared with control for different ceiling ratios (€) for quality-adjusted life-years
Fig. 3
Fig. 3
Cost-effectiveness acceptability curve indicating the probability of the intervention conditions’ being cost-effectiveness compared with control for different ceiling ratios (€) for back-pain
Fig. 4
Fig. 4
Cost-effectiveness acceptability curve indicating the probability of the intervention conditions’ being cost-effectiveness compared with control for different ceiling ratios (€) for leg pain
Fig. 5
Fig. 5
Cost-effectiveness acceptability curve indicating the probability of the intervention conditions’ being cost-effectiveness compared with control for different ceiling ratios (€) for physical functioning
Fig. 6
Fig. 6
Cost-effectiveness acceptability curve indicating the probability of the intervention conditions’ being cost-effectiveness compared with control for different ceiling ratios (€) for self-perceived recovery
See this image and copyright information in PMC

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