Trial of Pregabalin for Acute and Chronic Sciatica.

BACKGROUND: Sciatica can be disabling, and evidence regarding medical treatments is limited. Pregabalin is effective in the treatment of some types of neuropathic pain. This study examined whether pregabalin may reduce the intensity of sciatica. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of pregabalin in patients with sciatica. Patients were randomly assigned to receive either pregabalin at a dose of 150 mg per day that was adjusted to a maximum dose of 600 mg per day or matching placebo for up to 8 weeks. The primary outcome was the leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at week 8; the leg-pain intensity score was also evaluated at week 52, a secondary time point for the primary outcome. Secondary outcomes included the extent of disability, back-pain intensity, and quality-of-life measures at prespecified time points over the course of 1 year. RESULTS: A total of 209 patients underwent randomization, of whom 108 received pregabalin and 101 received placebo; after randomization, 2 patients in the pregabalin group were determined to be ineligible and were excluded from the analyses. At week 8, the mean unadjusted leg-pain intensity score was 3.7 in the pregabalin group and 3.1 in the placebo group (adjusted mean difference, 0.5; 95% confidence interval [CI], -0.2 to 1.2; P=0.19). At week 52, the mean unadjusted leg-pain intensity score was 3.4 in the pregabalin group and 3.0 in the placebo group (adjusted mean difference, 0.3; 95% CI, -0.5 to 1.0; P=0.46). No significant between-group differences were observed with respect to any secondary outcome at either week 8 or week 52. A total of 227 adverse events were reported in the pregabalin group and 124 in the placebo group. Dizziness was more common in the pregabalin group than in the placebo group. CONCLUSIONS: Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group. (Funded by the National Health and Medical Research Council of Australia; PRECISE Australian and New Zealand Clinical Trials Registry number, ACTRN12613000530729 .).

Minimally important change values of a measurement instrument depend more on baseline values than on the type of intervention.

OBJECTIVES: Multi-item questionnaires are frequently used to measure outcomes in randomized controlled trials (RCTs) in patients with sciatica. Knowing the minimaly important change (MIC) values for these instruments will facilitate interpretation of change scores. MIC values have been shown to be dependent on baseline values. The question is whether they also depend on the type of intervention. To estimate the MIC of the Roland Morris Disability Questionnaire (modified 23 item version) (RMDQ) and of intensity of leg pain measured by a Visual Analogue Scale (VAS) in patients with sciatica and to assess to what extent MIC values depend on type of intervention and on baseline values. STUDY DESIGN AND SETTING: This is a secondary analysis of RCT data of the effects of early surgery vs. prolonged conservative treatment in patients with sciatica. Baseline and 8-week data were used to assess MIC of the RMDQ-23 and VAS leg pain. We used the receiver operator characteristic (ROC) method to assess the MIC. Global Perceived Recovery (rated 8 weeks after baseline) was used as anchor. Subgroups were created based on type of treatment and baseline severity. RESULTS: The MIC value of the RMDQ-23 for the total group of sciatica patients was 7.5. The values were 8.1 and 6.9 for surgery and conservative treatment, respectively. For high and low baseline values, the MICs were 9.0 and 4.9, respectively, irrespective of treatment received. The MIC values of the VAS leg pain were 34.4 for the total group. For surgery and conservative treatment, the MIC values were 38.5 and 30.4, respectively, whereas for groups with high and low baseline values, MIC values of 53.5 and 17.2 were found. CONCLUSION: The MIC values of the RMDQ-23 and VAS leg pain were found to be highly dependent on their baseline values, although the type of intervention appeared to influence the MIC value only slightly.

Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study.

The objective is to determine if pain and disability outcomes of patients treated with neural mobilisation differ for sub-classifications of low back and leg pain (LB&LP). Radiating leg pain is a poor prognostic factor for recovery in patients with LBP. To improve outcome, a new pathomechanism-based classification system was proposed: neuropathic sensitization (NS), denervation (D), peripheral nerve sensitization (PNS) and musculoskeletal (M). Seventy-seven patients with unilateral LB&LP were recruited. Following classification, all subjects were treated seven times with neural mobilisation techniques. A successful outcome was defined as achieving a minimal clinically important change in pain intensity (11-point numerical rating scale), physical function (Roland Morris disability questionnaire) and global perceived change (7-point Likert scale: from 1 = "completely recovered" to 7 = "worse than ever"). The proportion of responders was significantly greater in PNS (55.6%) than the other three groups (NS 10%; D 14.3% and M10%). After adjusting for baseline differences, mean magnitude of improvement of the outcome measures were significantly greater in PNS compared to the other groups. Patients classified as PNS have a more favourable prognosis following neural mobilisation compared to the other groups.

Classification of low back-related leg pain--a proposed patho-mechanism-based approach.

Leg pain is a frequent accompaniment to low back pain, arising from disorders of neural or musculoskeletal structures of the lumbar spine. Differentiating between different sources of radiating leg pain is important to make an appropriate diagnosis and identify the underlying pathology. It is proposed that low back-related leg pain be divided into four subgroups according to the predominating pathomechanisms involved. The first subgroup features central sensitization with mainly positive symptoms such as hyperalgesia, the second subgroup involves denervation with significant axonal damage showing predominantly negative sensory symptoms and possibly motor loss and the third subgroup involves peripheral nerve sensitization with enhanced nerve trunk mechanosensitization. The fourth subgroup features somatic referred pain from musculoskeletal structures, such as the intervertebral disc or facet joints. Accordingly, four groups of patients with leg pain associated with structures in the lower back can be identified: Each group presents with a distinct pattern of symptoms and signs. Although there may be considerable overlap between the classifications, the authors propose the existence of an overriding mechanism. The importance of distinguishing low back-related leg pain into these four groups is to facilitate diagnosis and provide a more effective, appropriate treatment.

Differential diagnosis of intraspinal and extraspinal non-discogenic sciatica.

The aim of this study is to present a series of 11 patients with non-discogenic sciatica (NDS), and to review the diagnostic techniques of careful clinical and radiological examination. The cases include lumbar radicular herpes zoster, lumbar nerve root schwannoma, lumbar instability, facet hypertrophy, ankylosing spondylitis, sacroiliitis, sciatic neuritis, piriformis syndrome, intrapelvic mass and coxarthrosis. The pain pattern and accompanying symptoms were the major factors suggesting a non-discogenic etiology. Pelvic MRI and CT scans, and sciatic nerve magnetic resonance neurography were the main diagnostic tools for diagnosis of NDS. The treatment of choice depended on the primary diagnosis. Detailed physical examinations with special attention paid to the extraspinal causes of sciatica and to pain characteristics are the major components of differential diagnosis of NDS.

[Practicability of a German version of the "Oswestry Low Back Pain Disability Questionnaire". A questionnaire to assess disability caused by back pain]. / Praxistauglichkeit einer deutschen Version des "Oswestry Low Back Pain Disability Questionnaire". Ein Fragebogen zur Beeinträchtigung durch Rückenschmerzen.

While caring for patients with chronic low back pain, a standardized measurement of pain and pain-related reduction of the quality of life is needed. Easy application and data collection are decisive for routine use. The Oswestry Low Back Pain Disability Questionnaire is an internationally widely used instrument, which was now scrutinized in 148 patients in two orthopedic hospitals. A higher pain disability was related to age, female gender, limitations experienced in social life, impact of pain, use of analgetics, low net income, and patients in Eastern Germany. The available German version of the questionnaire is suitable for daily use to measure the intensity of pain and pain-related disability in everyday life, including social impairment due to low back pain.

Responsiveness and minimal clinically important difference for pain and disability instruments in low back pain patients.

BACKGROUND: The choice of an evaluative instrument has been hampered by the lack of head-to-head comparisons of responsiveness and the minimal clinically important difference (MCID) in subpopulations of low back pain (LBP). The objective of this study was to concurrently compare responsiveness and MCID for commonly used pain scales and functional instruments in four subpopulations of LBP patients. METHODS: The Danish versions of the Oswestry Disability Index (ODI), the 23-item Roland Morris Disability Questionnaire (RMQ), the physical function and bodily pain subscales of the SF36, the Low Back Pain Rating Scale (LBPRS) and a numerical rating scale for pain (0-10) were completed by 191 patients from the primary and secondary sectors of the Danish health care system. Clinical change was estimated using a 7-point transition question and a numeric rating scale for importance. Responsiveness was operationalized using standardized response mean (SRM), area under the receiver operating characteristic curve (ROC), and cut-point analysis. Subpopulation analyses were carried out on primary and secondary sector patients with LBP only or leg pain +/- LBP. RESULTS: RMQ was the most responsive instrument in primary and secondary sector patients with LBP only (SRM = 0.5-1.4; ROC = 0.75-0.94) whereas ODI and RMQ showed almost similar responsiveness in primary and secondary sector patients with leg pain (ODI: SRM = 0.4-0.9; ROC = 0.76-0.89; RMQ: SRM = 0.3-0.9; ROC = 0.72-0.88). In improved patients, the RMQ was more responsive in primary and secondary sector patients and LBP only patients (SRM = 1.3-1.7) while the RMQ and ODI were equally responsive in leg pain patients (SRM = 1.3 and 1.2 respectively). All pain measures demonstrated almost equal responsiveness. The MCID increased with increasing baseline score in primary sector and LBP only patients but was only marginally affected by patient entry point and pain location. The MCID of the percentage change score remained constant for the ODI (51%) and RMQ (38%) specifically and differed in the subpopulations. CONCLUSION: RMQ is suitable for measuring change in LBP only patients and both ODI and RMQ are suitable for leg pain patients irrespectively of patient entry point. The MCID is baseline score dependent but only in certain subpopulations. Relative change measured using the ODI and RMQ was not affected by baseline score when patients quantified an important improvement.

Lumbociática aguda unilateral causada por angioma cavernoso intramedular / Unilateral acute lumbar-radicular pain caused by an intramedullary cavernous angioma

No disponible

No disponible

Longitudinal study of vertebral type-1 end-plate changes on MR of the lumbar spine.

The purpose of this study was to investigate the temporal evolution of type-1 end-plate changes on MRI in patients with degenerative disease of the lumbar spine and to evaluate whether any correlation exists between such evolution and the change in patients' symptoms. Forty-four patients with 48 Modic type-1 end-plate changes (low TI signal and high T2 signal) were studied. All patients had an initial and a follow-up non-contrast lumbar MRI with variable intervals between the studies (12-72 months). Severity of the end-plate changes was assessed by eyeball estimation. Correlation with patients' symptoms was studied with the help of the Visual Analogue Score (VAS), Oswestry Questionnaire Score (OQS) and patients' subjective assessment. Of the 48 disc levels with type-1 changes, 18 (37.5%) converted fully to type 2 (high T1 signal and intermediate to high T2 signal), 7 (14.6%) partially converted to type 2, 19 (39.6%) became worse (i.e. type 1 changes became more extensive) and 4 (8.3%) showed no change. Higher average VAS (5.7) and OQS (42.3) scores were noted in patients where there was worsening type-1 change and lower scores (3.8 and 27, respectively) were seen in those where there was conversion to type-2 change. These trends, however, did not reach statistical significance (P values 0.16 and 0.09 for VAS and OQS, respectively). The statistical relationship was stronger after exclusion of patients with confounding factors (i.e. changes in lumbar MRI other than end-plate changes that could independently explain the evolution of patients' symptoms) with P-values of 0.08 and 0.07 for VAS and OQS, respectively. Type-1 end-plate change represents a dynamic process and in a large majority of cases either converts to type-2 change or becomes more extensive. The evolution of type-1 change relates to change in patient's symptoms, but not to a statistically significant level.

Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial.

OBJECTIVES: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. STUDY DESIGN: Prospective, observer-blinded, pilot randomized clinical trial. SETTING: Primary contact chiropractic and medical clinics. PATIENTS: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica). OUTCOME MEASURES: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. The measures included leg and back pain severity, frequency and bothersomeness of symptoms, leg/back disability, medication use, global improvement, satisfaction, and health care utilization. INTERVENTIONS: Medical care, chiropractic care, and epidural steroid injections. RESULTS: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients were randomized into the study. All 3 groups showed substantial improvements in the main patient-rated outcomes at the end of the 12-week intervention phase. For leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score, the percent improvement varied from 50% to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bothersomeness of leg symptoms was the most responsive outcome associated with the largest magnitude of effect size. All within-group changes from baseline were statistically significant (P <.01). No between-group comparisons were planned or performed because of the insufficient sample size and high risk of committing type I and type II errors. CONCLUSIONS: Pilot studies such as these are important for the determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible, given the methods used in this pilot study. Our results do indicate, however, that there are substantial numbers of patients with sciatica more chronic in nature who would be interested in participating in a similar study. In addition, collaboration with a local health maintenance organization would likely facilitate clinician referrals and optimize the recruitment process. Patient and provider compliance was high in the pilot study, which indicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care use. A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 4 weeks duration has been planned before a full-scale trial is attempted.

The Quebec Task Force classification for Spinal Disorders and the severity, treatment, and outcomes of sciatica and lumbar spinal stenosis.

STUDY DESIGN: A prospective cohort study of patients in Maine with sciatica and lumbar spinal stenosis treated surgically and nonsurgically. SUMMARY OF BACKGROUND DATA: In 1987, the Quebec Task Force on Spinal Disorders proposed a diagnostic classification to help make clinical decisions, evaluate quality of care, assess prognosis, and conduct research. OBJECTIVES: To assess the Quebec Task Force classification's ability to stratify patients according to severity and treatment at baseline, and to assess changes over time in health-related quality of life, including symptoms, functional status, and disability. METHODS: Five hundred sixteen patients participating in the Maine Lumbar Spine Study who completed baseline and 1-year follow-up evaluations were classified successfully according to the Quebec Task Force classification. Patient characteristics and treatments were compared across Quebec Task Force classification categories. Changes in health-related quality of life over 1 year were assessed according to Quebec Task Force classification category and type of treatment. RESULTS: Among patients with sciatica (n = 370), higher Quebec Task Force classification categories (from 2, pain radiating to the proximal extremity, to 6, sciatica with evidence of nerve root compression) were associated with increased severity of symptoms at baseline. There was no association between Quebec Task Force classification and baseline functional status. Quebec Task Force classification was associated strongly with the likelihood of receiving surgical treatment (P < or = 0.005). Among patients with sciatica treated nonsurgically, improvement at 1 year in back-specific and generic physical function increased with higher Quebec Task Force classification category (P < or = 0.05). Only a nonsignificant trend was observed for surgically treated patients. Patients with lumbar spinal stenosis (Quebec Task Force classification 7, n = 131) had baseline features and outcomes distinct from patients with sciatica. CONCLUSIONS: For patients with sciatica, the Quebec Task Force classification was highly associated with the severity of symptoms and the probability of subsequent surgical treatment. Nonsurgically treated patients in Quebec Task Force classification categories reflecting nerve root compression had greater improvement than those with pain symptoms alone. Among surgical patients, the Quebec Task Force classification was not associated with outcome. These results provide validation for the classification and its wider adoption. Nonetheless, improved diagnostic classifications are needed to predict outcomes better in patients with sciatica who undergo surgery.

Justification of hospital days and epidemiology of discharge delays in a department of neurology.

We have developed a protocol to identify unnecessary days of hospitalisation in the Department of Neurology of the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. Seventy-four parameters (medical, social, type of investigation and treatment, degree of disability and of dependence) potentially associated with the length of stay were studied prospectively in 511 nonselected patients consecutively admitted to the Department over a period of 5 months. Each day spent on the wards was analyzed on a day-to-day basis and was classified into one of two groups: those due to a medical reason (4,700 hospital days), and those due to a nonmedical reason (1,184 days). These delays resulted chiefly from difficulties in obtaining laboratory investigations, especially in patients who were not disabled and who had been admitted for investigations (3.8% of hospital days, compared to 1.5% for patients with severe or total dependence) or from awaiting transfer to either another department or a nursing home. This second cause of delay markedly increased the length of stay of patients with severe or total dependence and with limited mobility on the first day (26.0 days, compared with 7.4 days for nondisabled patients) and, above all, on the last day spent in our Department (27.0 days, compared with 8.0 days). The ongoing analysis of these data may provide information as to which parameters could be influenced by neurologists in order to reduce the length of stay in hospital.

[Questionnaire method of evaluating the effectiveness of the treatment of pain]. / Kwestionariuszowa metoda oceny skutecznosci postepowania przeciwbólowego.

A Polish version of pain questionnaire for pain intensity definition has been prepared after an inquiry study on the "pain glossary" which showed that in the Polish language a large number of words are used for characterization of pain. These words contain information about pain intensity understandable for the studied population. The authors describe this questionnaire and discuss a preliminary evaluation of its usefulness for assessing the effectiveness of pain management. The presented questionnaire makes possible evaluation of pain intensity in several indices whose values correlate significantly with each other. In comparative investigations a significant correlation has been found also between the indices of pain intensity in the questionnaire and the index in the 24-hour observation card. The mean differences of pain intensity scores calculated before and after the treatment differed significantly in definite categories of verbal evaluation of treatment effectiveness. This justifies the conclusion that the questionnaire may be useful for evaluating treatment effectiveness by a method not depending on the utterances of the patients.