Neurosurgery Blog

Spine 2010;35:848–857

Study Design. Open label randomized controlled trial with 3-, 6-, 12-month, and 2- to 3-year follow-up.

Objective. To investigate the effectiveness of a psychomotor therapy focusing on cognition, behavior, and motor relearning compared with exercise therapy applied during the first 3 months after lumbar fusion.

Summary of Background Data. Postoperative management after lumbar fusion commonly focuses on analgesic pain control and activities of daily living. After 3 months, exercise therapy is often implemented. No randomized controlled trial has investigated early rehabilitation techniques conducted during the first 3 months after surgery.

Methods. The study recruited 107 patients, aged 18 to 65 years, selected for lumbar fusion because of 12 months of symptomatic spinal stenosis, spondylosis, degenerative/isthmic spondylolisthesis, or degenerative disc disease. The exercise therapy group received a home program focusing on pain contingent training of back, abdominal, and leg muscle functional strength and endurance, stretching, and cardiovascular fitness. The psychomotor therapy group received a home program and 3 outpatient sessions focusing on modifying maladaptive pain cognitions, behaviors, and motor control. Rated questionnaires investigating functional disability, pain, health-related quality of life, functional self-efficacy, outcome expectancy, fear of movement/(re)injury, and coping were assessed at 3, 6, 12 months, and 2 to 3 years after surgery.

Results. Follow-up rates were 93% at 12 months and 81% at 2 to 3 years after surgery. Psychomotor therapy improved functional disability, self-efficacy, outcome expectancy, and fear of movement/(re)injury significantly more than exercise therapy at respective follow-up occasions. Similar results occurred for pain coping but group differences were nonsignificant at 2 to 3 years follow-up. Potentially clinical relevant higher reoperation rates occurred after psychomotor therapy but rates were within normal ranges.

Conclusion. The study shows that postoperative rehabilitation can be safely implemented during the first 3 months after lumbar fusion and should include measures to modify psychological as well as motor functions.

Lancet Neurol 2010; 9: 353–62. DOI:10.1016/S1474- 4422(10)70057-0

The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups.

Methods: Patients with recently symptomatic carotid artery stenosis enrolled in ICSS were randomly assigned in a 1:1 ratio to receive carotid artery stenting or endarterectomy. Of 50 centres in ICSS, seven took part in the MRI substudy. The protocol specified that MRI was done 1–7 days before treatment, 1–3 days after treatment (post-treatment scan), and 27–33 days after treatment. Scans were analysed by two or three investigators who were masked to treatment. The primary endpoint was the presence of at least one new ischaemic brain lesion on diffusion-weighted imaging (DWI) on the post-treatment scan. Analysis was per protocol. This is a substudy of a registered trial, ISRCTN 25337470.

Findings: 231 patients (124 in the stenting group and 107 in the endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5∙21, 95% CI 2∙78–9∙79; p<0∙0001). At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5·93, 95% CI 2·25–15·62; p=0·0003). In patients treated at a centre with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12·20, 95% CI 4·53–32·84), whereas in those treated at a centre with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2·70, 1·16–6·24; interaction p=0·019).

Interpretation: About three times more patients in the stenting group than in the endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions.

J Neurosurg 112:681–688, 2010. DOI: 10.3171/2009.4.JNS081377

The object of this study was to determine the efficacy of methylprednisolone in reducing symptomatic vasospasm and poor outcomes after subarachnoid hemorrhage (SAH).

Methods. Ninety-five patients with proven SAH were recruited into a double-blind, placebo-controlled, random- ized trial. Starting within 6 hours after angiographic diagnosis of aneurysm rupture, placebo or methylprednisolone, 16 mg/kg, was administered intravenously every day for 3 days to 46 and 49 patients, respectively. Deterioration, defined as development of a focal sign or decrease of more than 1 point on the Glasgow Coma Scale for more than 6 hours, was investigated by using clinical criteria and transcranial Doppler ultrasonography, cerebral angiography, or CT when appropriate. The end points were incidence of symptomatic vasospasm (delayed ischemic neurological deficits associated with angiographic arterial narrowing or accelerated flow on Doppler ultrasonography, or both) and outcome 1 year after entry into the study according to a simplified Rankin scale (Functional Outcome Scale [FOS]) in living patients and the Glasgow Outcome Scale in all patients included.

Results. All episodes of deterioration and all living patients with a 1-year outcome were assessed by a review committee. In patients treated with methylprednisolone, the incidence of symptomatic vasospasm was 26.5% com- pared with 26.0% in those given placebo. Poor outcomes according to FOS were significantly reduced in the Meth- ylprednisolone Group at 1 year of follow-up; the risk difference was 19.3% (95% CI 0.5–37.9%). The outcome was poor in 15% (6/40) of patients in the Methylprednisolone Group versus 34% (13/38) in the Placebo Group.

Conclusions. A safe and simple treatment with methylprednisolone did not reduce the incidence of symptomatic vasospasm but improved ability and functional outcome at 1 year after SAH.

Eur Spine J (2009) 18:1836–1842DOI 10.1007/s00586-009-1019-4

Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established.

The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain.

This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)–tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober’s test and lateral body bending test) and patient’s and investigator’s global efficacy assessment.

Aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac–tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated.

In this study, aceclofenac–tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.

J Neurosurg 111:1175–1178, 2009.(DOI: 10.3171/2009.5.JNS081481)

Object. In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to local  ized microscopic tissue damage and subsequent delayed wound healing.

Methods. The trial consisted of 2 arms in which different methods were used to secure scalp hemostasis: 1) the routinely­used­plastic­clips (Scalpfix,­Aesculap); and 2)­the older method of artery forceps placed on the galea. Participants were restricted to those > 16 years of age undergoing craniotomies expected to last > 2 hours. Repeat operations were not included. One hundred fifty patients were enrolled.­They were visited at 3 and 6 weeks postoperativel by an observer blinded to the method used, and the wounds were assessed for macroscopic epithelial closure, signs of­infection, and hair regrowth by using a predefined assessment scale.

Results.­The results showed no significant difference in wound healing between the 2 groups at either 3 weeks (OR 0.55, 95% CI 0.27–1.11; p = 0.09) or 6 weeks (OR 0.79, 95% CI 0.39–1.58; p = 0.50). The length of operation was found to be a significant factor affecting wound healing at 6 weeks (OR/hour 0.68,­95%­CI 0.51–0.92; p­=0.01)

Conclusions.­The use of Aesculap Scalpfix self-retaining plastic scalp clips on the skin edge during craniotomy surgery does not appear to affect wound healing significantly to the postoperative 6 week mark.

Eur Spine J (2009) 18:1843–1850 DOI 10.1007/s00586-009-1044-3

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non- invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person’s body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (±25) to 32 (±27) with the IDD protocol and 53 (±26) to 36 (±27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.

JAMA. 2009;302(2):149-158.

Context Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking of its efficacy.

Objective To determine outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy.

Design, Setting, and Patients The Sciatica Micro-Endoscopic Diskectomy randomized controlled trial was conducted among 328 patients aged 18 to 70 years who had persistent leg pain (>8 weeks) due to lumbar disk herniations at 7 general hospitals in the Netherlands from January 2005 to October 2006. Patients and observers were blinded during the follow-up, which ended 1 year after final enrollment.

Interventions Tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161).

Main Outcome Measures The primary outcome was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica (score range: 0-23, with higher scores indicating worse functional status) at 8 weeks and 1 year after randomization. Secondary outcomes were scores on the visual analog scale for leg pain and back pain (score range: 0-100 mm) and patient’s self-report of recovery (measured on a Likert 7-point scale).

Results Based on intention-to-treat analysis, the mean RDQ score during the first year after surgery was 6.2 (95% confidence interval [CI], 5.6 to 6.8) for tubular diskectomy and 5.4 (95% CI, 4.6 to 6.2) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, –0.2 to 1.7). At 8 weeks after surgery, the RDQ mean (SE) score was 5.8 (0.4) for tubular diskectomy and 4.9 (0.5) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, –0.4 to 2.1). At 1 year, the RDQ mean (SE) score was 4.7 (0.5) for tubular diskectomy and 3.4 (0.5) for conventional microdiskectomy (between-group mean difference, 1.3; 95% CI, 0.03 to 2.6) in favor of conventional microdiskectomy. On the visual analog scale, the 1-year between-group mean difference in improvement was 4.2 mm (95% CI, 0.9 to 7.5 mm) for leg pain and 3.5 mm (95% CI, 0.1 to 6.9 mm) for back pain in favor of conventional microdiskectomy. At 1 year, 107 of 156 patients (69%) assigned to tubular diskectomy reported a good recovery vs 120 of 151 patients (79%) assigned to conventional microdiskectomy (odds ratio, 0.59 [95% CI, 0.35 to 0.99]; P = .05).

Conclusions Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score. Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery.

Journal of Neurosurgical Anesthesiology: July 2009 – Volume 21 – Issue 3 – pp 226-230. doi: 10.1097/ANA.0b013e3181a7beaa

Postoperative nausea and vomiting (PONV) are frequent and distressing complications after neurosurgical procedures. We evaluated the efficacy of ondansetron and granisetron to prevent PONV after supratentorial craniotomy. In a randomized double-blind, placebo controlled trial, 90 adult American Society of Anesthesiologists I, II patients were included in the study. A standard anesthesia technique was followed. Patients were divided into 3 groups to receive either placebo (saline), ondansetron 4 mg, or granisetron 1 mg intravenously at the time of dural closure. After extubation, episodes of nausea and vomiting were noted for 24 hours postoperatively. Statistical analysis was performed using χ² test and 1-way analysis of variance. Demographic data, duration of surgery, intraoperative fluids and analgesic requirement, and postoperative pain (visual analog scale) scores were comparable in all 3 groups. It was observed that the incidence of vomiting in 24 hours, severe emetic episodes, and requirement of rescue antiemetics were less in ondansetron and granisetron groups as compared with placebo (P<0.001). Both the study drugs had comparable effect on vomiting. However, the incidence of nausea was comparable in all 3 groups (P=0.46). A favorable influence on the patient satisfaction scores, and number needed to prevent emesis was seen in the 2 drug groups. No significant correlation was found between neurosurgical factors (presence of midline shift, mass effect, pathologic diagnosis of tumor, site of tumor) and the occurrence of PONV. We conclude that ondansetron 4 mg and granisetron 1 mg are comparably effective at preventing emesis after supratentorial craniotomy. However, neither drugs prevented nausea effectively.

NEJM (361): 569-579. Aug 6, 2009

Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.

Methods In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland–Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients’ ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.

Results All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], –1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, –0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (43% vs. 12%, P<0.001). There was one serious adverse event in each group.

Conclusions Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822 [ClinicalTrials.gov] .)