Epidural administration of spinal nerves with the tumor necrosis factor-alpha inhibitor, etanercept, compared with dexamethasone for treatment of sciatica in patients with lumbar spinal stenosis: a prospective randomized study.
METHODS
Prospective randomized trial.


OBJECTIVE
To examine the effect of the tumor necrosis factor alpha (TNF-α) inhibitor, etanercept, on radicular pain by its epidural administration onto spinal nerves in patients with lumbar spinal stenosis.


BACKGROUND
TNF-α is thought to play a crucial role in the radicular pain caused by lumbar disc herniation and spinal stenosis. Intravenous infusion of infliximab for sciatica has been examined in 2 studies; however, the results were equivocal.


METHODS
Eighty patients with low back and radicular leg pain were investigated. We diagnosed the patients by physical examination, and X-ray and magnetic resonance imaging. In 40 patients, we epidurally administered 2.0 mL of lidocaine and 10 mg of etanercept onto the affected spinal nerve, and 2.0 mL of lidocaine and 3.3 mg of dexamethasone was used in 40 patients. Low back pain, leg pain, and leg numbness were evaluated using a visual analogue scale (VAS) and Oswestry Disability Index (ODI) score before and for 1 month after epidural administration.


RESULTS
Low back pain, leg pain, and leg numbness in the 2 groups were not significantly different before epidural administration. Epidural administration of etanercept was more effective than dexamethasone for leg pain (3 days, and 1, 2, and 4 weeks: P < 0.05), low back pain (3 days, and 1 and 2 weeks: P < 0.05), and leg numbness (3 days, and 1 and 2 weeks: P < 0.05). No adverse event was observed in either group.


CONCLUSIONS
Our results indicate that epidural administration of a TNF-α inhibitor onto the spinal nerve produced pain relief, but no adverse event. TNF-α inhibitors may be useful tools for the treatment of radicular pain caused by spinal stenosis.
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. sohtori@faculty.chiba-u.jp
Seiji
S
Ohtori
Masayuki
M
Miyagi
Yawara
Y
Eguchi
Gen
G
Inoue
Sumihisa
S
Orita
Nobuyasu
N
Ochiai
Shunji
S
Kishida
Kazuki
K
Kuniyoshi
Junichi
J
Nakamura
Yasuchika
Y
Aoki
Tetsuhiro
T
Ishikawa
Gen
G
Arai
Hiroto
H
Kamoda
Miyako
M
Suzuki
Masashi
M
Takaso
Takeo
T
Furuya
Tomoaki
T
Toyone
Kazuhisa
K
Takahashi
D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D007268:Injections, Epidural; D017116:Low Back Pain / Q000188:drug therapy / Q000209:etiology; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor / Q000008:administration & dosage / Q000627:therapeutic use*; D012585:Sciatica / Q000188:drug therapy* / Q000209:etiology; D013127:Spinal Nerves / Q000187:drug effects*; D013130:Spinal Stenosis / Q000150:complications*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D000893:Anti-Inflammatory Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D014409:Tumor Necrosis Factor-alpha; D003907:Dexamethasone; D000068800:Etanercept