Róbert Rapčan1,2,3, Ladislav Kočan4, Juraj Mláka5, Miroslav Burianek1, Hana Kočanová6, Simona Rapčanová1, Michael Hess7, Anthony Hammond8, Martin Griger2, Michal Venglarčík3, Miroslav Gajdoš9, Janka Vašková10. 1. Europainclinics, Prague, Czech Republic. 2. Europainclinics, Nové Mesto, Slovak Republic. 3. Europainclinics, Bardejov, Slovak Republic. 4. Clinic of Anaesthesiology and Intensive Care Medicine, East Slovak Institute of Cardiovascular Disease, Košice, Slovak Republic. 5. Europainclinics, Poliklinika Terasa, Košice, Slovak Republic. 6. Clinic of Anaesthesiology and Intensive Care Medicine, Railway Hospital and Clinic Košice, Košice, Slovak Republic. 7. Wirbelsäuleninstitut, Munich, Munich, Germany. 8. Kent Institute of Medicine and Surgery, Kent, UK. 9. Department of Neurosurgery, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, and Louis Pasteur University Hospital, Košice, Slovak Republic. 10. Department of Medical and Clinical Biochemistry, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice, Slovak Republic.
Abstract
OBJECTIVE:Epiduroscopy is a proven method of diagnosis and treatment for chronic radicular pain after spinal surgery, which is known as failed back surgery syndrome (FBSS). The aim of the study was to compare the efficacy of drugs (the enzyme hyaluronidase and corticosteroid DEPO-Medrol) administrated into the epidural space during epiduroscopy, performed within the ventral and ventro-lateral epidural space with a focus on releasing foraminal adhesions. METHODS:Forty-eight patients with diagnosed FBBS were randomized into two groups before epiduroscopy. Group A received the standard treatment-mechanical lysis of fibrotic tissue in the epidural space. Group B received hyaluronidase and corticosteroid methylprednisolone acetate during the procedure. Subjects were followed for six and 12 months via scheduled double-blinded examinations by pain physicians. Leg and back pain intensity was assessed by an 11-point numerical rating scale, and patients' functional disability was assessed by the Oswestry Disability Index (ODI). RESULTS: Study subjects showed a significant decrease in ODI score in both groups (P < 0.05). Significantly lower pain scores for leg pain (P < 0.05) and back pain (P < 0.05) were also recorded after the six-month follow-up. However, the one-year follow-up showed a return to the baseline ODI values of most monitored pain scores in both groups (P > 0.05). Improvement was only noted on the NRS for back pain at one-year follow-up (P < 0.05). CONCLUSIONS: A significant improvement of leg and back pain was found in both groups after six months. ODI was significantly improved only in group B in both the six- and 12-month intervals. Back pain at one-year follow-up was only improved in group B.
RCT Entities:
OBJECTIVE: Epiduroscopy is a proven method of diagnosis and treatment for chronic radicular pain after spinal surgery, which is known as failed back surgery syndrome (FBSS). The aim of the study was to compare the efficacy of drugs (the enzyme hyaluronidase and corticosteroid DEPO-Medrol) administrated into the epidural space during epiduroscopy, performed within the ventral and ventro-lateral epidural space with a focus on releasing foraminal adhesions. METHODS: Forty-eight patients with diagnosed FBBS were randomized into two groups before epiduroscopy. Group A received the standard treatment-mechanical lysis of fibrotic tissue in the epidural space. Group B received hyaluronidase and corticosteroid methylprednisolone acetate during the procedure. Subjects were followed for six and 12 months via scheduled double-blinded examinations by pain physicians. Leg and back pain intensity was assessed by an 11-point numerical rating scale, and patients' functional disability was assessed by the Oswestry Disability Index (ODI). RESULTS: Study subjects showed a significant decrease in ODI score in both groups (P < 0.05). Significantly lower pain scores for leg pain (P < 0.05) and back pain (P < 0.05) were also recorded after the six-month follow-up. However, the one-year follow-up showed a return to the baseline ODI values of most monitored pain scores in both groups (P > 0.05). Improvement was only noted on the NRS for back pain at one-year follow-up (P < 0.05). CONCLUSIONS: A significant improvement of leg and back pain was found in both groups after six months. ODI was significantly improved only in group B in both the six- and 12-month intervals. Back pain at one-year follow-up was only improved in group B.
Authors: Róbert Rapčan; Ladislav Kočan; Viktor Witkovsky; Juraj Mláka; Martin Griger; Miroslav Burianek; Simona Rapčanová; Anthony Hammond; Ľubomír Poliak; Róbert Tirpák; Jana Šimonová; František Sabol; Janka Vašková Journal: Wien Klin Wochenschr Date: 2020-01-07 Impact factor: 1.704
Authors: Matthijs W Geudeke; Annelot C Krediet; Süleyman Bilecen; Frank J P M Huygen; Mienke Rijsdijk Journal: Pain Pract Date: 2020-12-26 Impact factor: 3.183