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2017 ; 18
(1
): 215
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Treatment of acute sciatica with transforaminal epidural corticosteroids and
local anesthetic: design of a randomized controlled trial
#MMPMID28545491
Ter Meulen BC
; Maas ET
; Vyas A
; van der Vegt M
; de Priester K
; de Boer MR
; van Tulder MW
; Weinstein HC
; Ostelo RWJG
BMC Musculoskelet Disord
2017[May]; 18
(1
): 215
PMID28545491
show ga
BACKGROUND: Transforaminal epidural injections with steroids (TESI) are used
increasingly for patients with sciatica. However there is much debate about their
safety and effectiveness. It is important to identify patients that benefit most
from TESI and only few trials have yet evaluated the effects in patients with
acute sciatica. METHODS: We describe a prospective, randomized controlled trial
(RCT), with the aim to evaluate the hypothesis that TESI plus Levobupivacaine
(TESI-plus) added to oral pain medication is more effective compared to pain
medication alone or compared to transforaminal injection with a local anesthetic
of short duration among patients with acute sciatica. We will recruit a total of
264 patients with sciatica (<8 weeks) caused by a herniated disc, from two
clinical sites. Participants are randomly assigned one of three study groups: 1)
oral pain medication (control group), 2) oral pain medication and TESI-plus
(intervention group one), 3) oral pain medication and transforaminal epidural
injection (TEI) with Levobupivaine and saline solution (intervention group two).
Primary outcomes are functional status (Roland-Morris Disability Questionnaire),
pain intensity for both leg and back, (100 mm visual analogous scale (VAS)), and
global perceived recovery (GPR, reported on a 7-point Likert scale, dichotomized
into 'recovered' and 'not recovered'). The secondary outcomes are health-related
quality of life (EQ5D-5 L) and patient satisfaction (7-point Likert scale). We
will also collect information on healthcare utilization and costs, to perform an
economic evaluation. All outcomes are measured at three and six weeks, three and
six months after randomization. We defined a minimal clinically relevant
difference between groups as a difference between both intervention groups and
the control group of 20 points for pain (100-point VAS), four points for
functional status (24-point RDQ) and a 20% difference on dichotomized GPR
(recovered versus not recovered). DISCUSSION: A clinically relevant outcome in
favor of TESI-plus implies that future patients with acute sciatica should be
recommended TESI-plus within the first few weeks rather than being treated with
pain medication alone in order to relieve pain and improve their functioning. In
case of a negative result (no relevant differences in outcome between the three
study arms), pain medication will remain the mainstay of treatment in the acute
stages of sciatica. TRIAL REGISTRATION: Dutch National trial register: NTR4457
(March, 6th, 2014).