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EULAR 2017 | Daily Highlights
INTRADISCAL GLUCOCORTICOID INJECTION FOR PATIENTS WITH CHRONIC LOW BACK PAIN ASSOCIATED WITH ACTIVE DISCOPATHY: A RANDOMIZED TRIALAbstract: LB0001
Authors: C. Nguyen1,*, I. Boutron1, G. Baron1, K. Sanchez2, C. Palazzo1, R. Benchimol2, G. Paris1, E. James-Belin2, M.-M. Lefèvre-Colau1, J. Beaudreuil3, J.-D. Laredo3, A. Béra-Louville4, A. Cotten4, J.-L. Drapé1, A. Feydy1, P. Ravaud1, F. Rannou1, S. Poiraudeau1
1Université Paris Descartes, 2Assistance Publique - Hôpitaux de Paris, 3Université Paris Diderot, Paris, 4Université Lille 2, Lille, France
Active discopathy is associated with a specific phenotype of chronic low back pain (cLBP). Local inflammation has a role in active discopathy-associated symptoms (1).
To assess the efficacy of a single glucocorticoid intradiscal injection (GC IDI) in cLBP patients with active discopathy.
We conducted a prospective, parallel-group, double-blind, randomized controlled study in 3 tertiary care centers in France. 135 cLBP patients with active discopathy on MRI were enrolled. They received a single GC IDI (25 mg prednisolone acetate) during discography (n=67) or discography alone (n=68). The primary outcome was the percentage of patients with LBP intensity in the previous 48 hr < 40 on an 11-point numeric rating scale (NRS, 0 no pain - 100 maximal pain) at 1 month. The main secondary outcomes were LBP intensity and persisting active discopathy on MRI at 12 months post-intervention, and spine-specific limitations in activities, health-related quality of life, anxiety and depression, employment status and analgesics and non-steroidal anti-inflammatory drugs consumption at 1 and 12 months.
All randomized patients were included in the primary efficacy analysis. At 1 month, the percentage of responders (LBP intensity < 40) was higher in the GC IDI than control group (36/65 [55.4%] vs 21/63 [33.3%]; absolute risk difference [95% confidence interval] 22.1 [5.5;38.7]); p=0.009. In the sensitivity analysis, mean reduction [95% CI] in LBP intensity from baseline to 1 month was greater in the GC IDI group compared to the control group (-32.5 [-38.2;-26.8] vs -17.5 [-23.3;-11.7], respectively; absolute difference [95% CI] -15.0 [-22.9;-7.1], p
At 1 month, the percentage of patients reporting an improvement in spine-specific limitations in activities was higher in the GC IDI than control group (55/65 [84.6%] vs 34/63 [54.0%]; absolute risk difference [95% CI] 30.5 [15.7; 45.2], p
In active discopathy-associated cLBP, a single GC IDI reduces LBP at 1 month post-intervention but not at 12 months.
Registration: ClinicalTrials.gov number NCT00804531 (First received: December 8, 2008. Last updated: June 23, 2016).
1. Nguyen C, Poiraudeau S, Rannou F. From Modic 1 vertebral-endplate subchondral bone signal changes detected by MRI to the concept of 'active discopathy'. Ann Rheum Dis. 2015 Aug;74(8):1488-94.
The study was funded by a research grant from the French Ministry of Health (Programme Hospitalier de Recherche Clinique, project no. P070157). The authors thank URC-CIC Paris Descartes Necker/Cochin (Christelle Auger and Nellie Moulopo) for implementation, monitoring and data management of the study.
Disclosure of Interest:
In this prospective, parallel-group, double-blind, randomized controlled trial 135 patients with chronic low back pain and active discopathy in MRI were included. 67 received 25 mg prednisolone acetate during discography and 68 only discography. In the primary study outcome (LBP intensitiy < 40 on NRS from 0 to 100) there was a significant greater number of patients in the glucocorticoid group (55.4 % versus 33.3) reaching this goal at 1 month. At 12 month the two groups did not differ in LBP intensity.In this RCT with 135 patients, glucocorticoid injections during discography did show only a small benefit in the short term (1 month) but not in the long term (12 months). This study confirms the opinion that discography has no role in the diagnosis and treatment of patients with chronic low back pain.
Dr. Thomas Langenegger