BACKGROUND: Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy. Yet, whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results, a placebo-controlled study failed to demonstrate efficacy. One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation. To date, no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents. METHODS: A double-blind, placebo-controlled, dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor. Twenty-four patients with subacute lumbosacral radiculopathy were randomly assigned to receive two transforaminal epidural injections of 2, 4, or 6 mg of entanercept 2 weeks apart in successive groups of eight. In each group, two patients received epidural saline. A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study. RESULTS: The animal and human safety studies revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity. In the clinical arm, significant improvements in leg and back pain were collectively noted for the etanercept-treated patients, but not for the saline group, one month after treatment. One patient in the saline group (17%), six patients in the 2-mg group (100%), and four patients each in the 4-mg and 6-mg groups (67%) reported at least 50% reduction in leg pain and a positive global perceived effect one month after treatment. Six months after treatment, the beneficial effects persisted in all but one patient. CONCLUSION: Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy.
AIM: The efficacy and safety of oral lornoxicam (LNX) as early treatment of acute sciatica/lumbo-sciatica was compared with placebo and diclofenac in a 5-day double-blind, randomised study.
METHODS: Male or female patients (n = 171) aged 18-70 years with acute sciatica or lumbo-sciatica [acute sciatica defined as typical radiation of pain along the sciatic nerve (including radiating pain below the knee) and worsening of pain as defined by Lasegue's leg-raising test (< 60 degrees ) within 72 h and previous attack ceased > 3 months previously; lumbo-sciatica defined as symptoms of sciatica with concurrent lumbar pain and a predefined minimum pain score]. The dosage of study treatment was 8-24 mg/day LNX, 100-150 mg/day diclofenac or placebo. The primary end-point was the difference in pain intensity difference from baseline to 6 h (PID(0-6 h)) after the first dose of study treatment. Secondary end-points were pain relief, the cumulative sums of pain intensity difference and total pain relief on day 1 and on days 2-4.
RESULTS: In total, 164 patients completed the study. Significant differences in PID between LNX and placebo were seen in the time interval 3-8 h after the first dose including PID(0-6 h) (p = 0.015). Secondary end-points favoured LNX vs. placebo, but in general were not significantly different. LNX and diclofenac had similar analgesic effect. Incidence and severity of adverse events were comparable for the three treatments; overall tolerability was rated as very good/good by 93% of the patients.
CONCLUSION: These data indicate that the analgesic efficacy of LNX is superior to placebo and similar to diclofenac in acute sciatica/lumbo-sciatica.
OBJECTIVE: To determine the difference in short- and long-term pain improvement between lumbar Epidural Steroid Injections (ESIs) and conservative management in patients with lumbar radiculopathy.
STUDY DESIGN: Quasi-experimental study.
PLACE AND DURATION OF STUDY: The Postgraduate Medical Institute of Hayatabad Medical Complex, Peshawar, from April 2005 to March 2007.
METHODOLOGY: Fifty elective patients fulfilling the inclusion criteria were randomly divided into two groups. Patients in the steroid group were treated with 80 mg of methylprednisolone injected in combination with 3 ml of 2% plain xylocaine and 3 ml of normal saline in the lumbar epidural space, while patients in the conservative group were treated with bed rest, non-steroidal anti-inflammatory agents, muscle relaxants, and opioids. All the 50 patients in the two groups were regularly assessed at 2 weeks, 1 month, 3 months and 6 months of periods for pain score by the Visual Analogue Scale (VAS), patients satisfaction score and any unwanted side effects.
RESULTS: A marked improvement of the pain score and patients satisfaction score were noticed in the steroid group. Less significant improvement was seen in the conservative group during the initial period i.e 2 weeks and 1 month (p < 0.05). The difference in Visual Analogue Scale (VAS) and patients satisfaction score was non-significant in chronic stages of treatment in both groups (p > 0.05).
CONCLUSION: Epidural steroid injections in acute symptoms of sciatica are considered to be a better option compared to conservative treatment.
Journal»Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan / sponsored by All-China Association of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine
OBJECTIVE: To observe the relation between the pain threshold and the therapeutic effects of acupuncture for sciatica.
METHODS: 90 sciatica patients were equally divided at random into the following 3 groups: a warming acupuncture group treated with the needles warmed by burning moxa, a western medicine group administered Nimesulide tablets and a point-injection group with Anisodamine injected. The pain threshold was tested before treatment and after the first, second and third treatment courses.
RESULTS: The warming acupuncture therapy showed better therapeutic effects than the other two groups with significant differences in the change of pain threshold and the improvement of clinical symptoms and signs (P<0.01).
CONCLUSION: Acupuncture can relieve the symptoms of sciatica with the increase of pain threshold.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
A prospective randomised 2-year follow-up study on patients undergoing lumbar disc herniation surgery. The objective was to investigate the relationship between peridural scarring and clinical outcome, the scar development 6 and 24 months postoperatively by using MRI, and if ADCON-L (a bioresorbable carbohydrate polymer gel) has an effect on scar size and/or improve patients' outcome after lumbar disc herniation surgery. The association between peridural scarring and recurrent pain after lumbar disc herniation surgery is debated. Numerous materials have been used in attempts to prevent or reduce postoperative peridural scarring; however, there are conflicting data regarding the clinical effects. The study included 119 patients whose mean age was 39 years (18-66); 51 (47%) were women. Sixty patients (56%) were perioperatively randomised to receive ADCON-L, and 48 (44%) served as controls. All patients underwent MRI at 6 and 24 months postoperatively, and an independent radiologist graded the size, location and development of the scar, by using a previously described scoring system. Pre- and 2-year postoperatively patients graded their leg pain on a visual analogue scale (VAS). At the 2-year follow-up patients rated their satisfaction with treatment (subjective outcome) and were evaluated by an independent neurologist (objective outcome), using MacNab score. There was no relationship between size or localisation of the scar and any of the clinical outcomes (VAS, subjective and objective outcome). The scar size decreased between 6 and 24 months in 49%, was unchanged in 42% and increased in 9% of the patients. Patients treated with ADCON-L did not demonstrate any adverse effects, nor did they demonstrate less scarring or better clinical outcome than control patients. No significant association between the presence of extensive peridural scar or localisation of scar formation and clinical outcome could be detected in the present study. Further, no positive or negative effects of ADCON-L used in disc herniation surgery could be seen.
OBJECTIVE: Many physicians use prednisone to treat acute sciatica with the hope of speeding recovery. There is little clinical evidence to support this practice. Our objective was to determine whether early administration of oral prednisone affects parameters related to recovery from acute sciatica.
METHODS: In this double-blind, controlled clinical trial, 27 patients were sequentially assigned to receive either a 9-day tapering course of prednisone (n = 13) or placebo (n = 14) within 1 week of developing sciatic symptoms. Patients and investigators were blinded to the drug administered. Follow-up assessment was done weekly for 1 month and then monthly for 5 months.
RESULTS: Prednisone and control groups showed no statistically significant differences in physical findings, use of nonsteroidal anti-inflammatory drugs or narcotic medications, or rates of patients returning to work at any time interval studied. Compared with controls, patients who received prednisone had more rapid rates of improvement from baseline in pain, mental well-being, and disability scores. These changes were subtle but statistically significant. Patients who received prednisone tended to receive fewer epidural injections for pain.
CONCLUSIONS: Early administration of oral steroid medication in patients with acute sciatica had no significant effect on most parameters studied. It did, however, lead to slightly more rapid rates of improvement in pain, mental well-being, and disability scores. The impact of oral steroids on other outcomes is suggested by this study, but its small sample size limited its statistical power.
OBJECTIVE: This study measures and compares the outcome of traction, ultrasound, and low-power laser (LPL) therapies by using magnetic resonance imaging and clinical parameters in patients presenting with acute leg pain and low back pain caused by lumbar disc herniation (LDH).
METHODS: A total of 60 patients were enrolled in this study and randomly assigned into 1 of 3 groups equally according to the therapies applied, either with traction, ultrasound, or LPL. Treatment consisted of 15 sessions over a period of 3 weeks. Magnetic resonance imaging examinations were done before and immediately after the treatment. Physical examination of the lumbar spine, severity of pain, functional disability by Roland Disability Questionnaire, and Modified Oswestry Disability Questionnaire were assessed at baseline, immediately after, and at 1 and 3 months after treatment.
RESULTS: There were significant reductions in pain and disability scores between baseline and follow-up periods, but there was not a significant difference between the 3 treatment groups at any of the 4 interview times. There were significant reductions of size of the herniated mass on magnetic resonance imaging after treatment, but no differences between groups.
CONCLUSIONS: This study showed that traction, ultrasound, and LPL therapies were all effective in the treatment of this group of patients with acute LDH. These results suggest that conservative measures such as traction, laser, and ultrasound treatments might have an important role in the treatment of acute LDH.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only. To assess the effectiveness of PT additional to general practitioners' care compared to general practitioners' care alone, in patients with acute sciatica. There is a lack of knowledge concerning the effectiveness of PT in patients with sciatica. The primary outcome was patients' global perceived effect (GPE). Secondary outcomes were severity of leg and back pain, severity of disability, general health and absence from work. The outcomes were measured at 3, 6, 12 and 52 weeks after randomisation. At 3 months follow-up, 70% of the intervention group and 62% of the control group reported improvement (RR 1.1; 95% CI 0.9-1.5). At 12 months follow-up, 79% of the intervention group and 56% of the control group reported improvement (RR 1.4; 95% CI 1.1; 1.8). No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up. At 12 months follow-up, evidence was found that PT added to general practitioners' care is only more effective regarding GPE, and not more cost-effective in the treatment of patients with acute sciatica than general practitioners' care alone. There are indications that PT is especially effective regarding GPE in patients reporting severe disability at presentation.
Recent evidence implicates the inflammatory cytokine tumor necrosis factor as a major cause of radiculopathy. Yet, whereas open-label studies with systemically delivered tumor necrosis factor inhibitors have yielded positive results, a placebo-controlled study failed to demonstrate efficacy. One variable that may have contributed to poor outcomes is low drug levels at the site of nerve inflammation. To date, no studies have evaluated the efficacy or safety of epidurally administered anti-tumor necrosis factor agents.
METHODS:
A double-blind, placebo-controlled, dose-response study was conducted to evaluate an epidural tumor necrosis factor inhibitor. Twenty-four patients with subacute lumbosacral radiculopathy were randomly assigned to receive two transforaminal epidural injections of 2, 4, or 6 mg of entanercept 2 weeks apart in successive groups of eight. In each group, two patients received epidural saline. A parallel epidural canine safety study was conducted using the same injection doses and paradigm as in the clinical study.
RESULTS:
The animal and human safety studies revealed no behavioral, neurologic, or histologic evidence of drug-related toxicity. In the clinical arm, significant improvements in leg and back pain were collectively noted for the etanercept-treated patients, but not for the saline group, one month after treatment. One patient in the saline group (17%), six patients in the 2-mg group (100%), and four patients each in the 4-mg and 6-mg groups (67%) reported at least 50% reduction in leg pain and a positive global perceived effect one month after treatment. Six months after treatment, the beneficial effects persisted in all but one patient.
CONCLUSION:
Epidural entanercept holds promise as a treatment for lumbosacral radiculopathy.
