Development of a German version of the Oswestry Disability Index. Part 2: sensitivity to change after spinal surgery

When functional scales are to be used as treatment outcome measures, it is essential to know how responsive they are to clinical change. This information is essential not only for clinical decision-making, but also for the determination of sample size in clinical trials. The present study examined the responsiveness of a German version of the Oswestry Disability Index version 2.1 (ODI) after surgical treatment for low back pain. Before spine surgery 63 patients completed a questionnaire booklet containing the ODI, along with a 0–10 pain visual analogue scale (VAS), the Roland Morris disability questionnaire, and Likert scales for disability, medication intake and pain frequency. Six months after surgery, 57 (90%) patients completed the same questionnaire booklet and also answered Likert-scale questions on the global result of surgery, and on improvements in pain and disability. Both the effect size for the ODI change score 6 months after surgery (0.87) and the area under the receiver operating characteristics (ROC) curve for the relative improvement in ODI score in relation to global outcome 6 months after surgery (0.90) indicated that the ODI showed good responsiveness. The ROC method revealed that a minimum reduction of the baseline (pre-surgery) ODI score by 18% (equal to a mean 8-point reduction in this patient group) represented the cut-off for indicating a good individual outcome 6 months after surgery (sensitivity 91.4% and specificity 82.4%). The German version of the ODI is a sensitive instrument for detecting clinical change after spinal surgery. Individual improvements after surgery of at least an 18% reduction on baseline values are associated with a good outcome. This figure can be used as a reliable guide for the determination of sample size in future clinical trials of spinal surgery.Part 1 of this article can be found at     

Wallis棘突间动态稳定系统在腰椎间盘突出症治疗中的早期疗效观察

[目的]比较髓核摘除术结合Wallis系统与单纯髓核摘除术治疗腰椎间盘突出症的早期疗效.[方法]2008年2月～2010年2月采用髓核摘除术结合Wallis系统治疗腰椎间盘突出症患者18例,以同期行单纯髓核摘除术治疗腰椎间盘突出症的18例患者为对照组.术后12个月为观察点,采用下腰痛及腿痛的视觉模糊评分(visual analogue scale,VAS)、Oswestry功能障碍指数(oswestry disability index,ODI)等指标来评估2组疗效.[结果]36例患者均获12 ～24个月随访,平均16个月,两组患者术后12个月的VAS评分及ODI指数均有明显下降,较术前比较有统计学意义(P=0.0000＜0.05),Wallis组术后12个月的下腰痛VAS评分及Oswestry指数与对照组比较有统计学意义(P =0.000 0 ＜0.05),而腿痛的VAS评分两组比较无统计学意义(P =0.074 ＞0.05).[结论]Wallis系统置入简单,创伤小,结合髓核摘除术治疗腰椎间盘突出症能提高疗效.     

Danish version of the Oswestry Disability Index for patients with low back pain. Part 1: Cross-cultural adaptation, reliability and validity in two different populations

Over the past 10 years, a plethora of back-specific patient-orientated outcome measures have appeared in the literature. Standardisation has been advocated by an expert panel of researchers proposing a core set of instruments. Of the condition-specific questionnaires the Oswestry Disability Index (ODI) is recommended for use with low back pain (LBP) patients. To date, no Danish version of the ODI exists which has been cross-culturally adapted, validated and published in the peer-reviewed literature. A cross-cultural adaptation and validation of the ODI for the Danish language was carried out according to established guidelines: 233 patients [half of the patients were seen in the primary sector (PrS) and half in the secondary sector (SeS) of the Danish health care system] with LBP and/or leg pain completed a questionnaire booklet at baseline, 1 day or 1 week and 8 weeks follow-up. The booklet contained the Danish version of the ODI, along with the Roland Morris Disability Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. For the ODI test–retest analysis (93 stable patients) resulted in an intraclass correlation coefficient of 0.91, a mean difference of 0.8 and 95% limits of agreements of − 11.5 to + 13. Thus, a worsening greater than 12 points and improvement greater than 13 points can be considered a “real” change above the measurement error. A substantial floor effect was found in PrS patients (14.1%). The ODI showed satisfactory cross-sectional discriminant validity when compared to the external measures. Concurrent validity of the ODI revealed: (a) a 10% and 21% lower ODI score compared to the disability and pain measures, respectively, (b) a poorer differentiation of patient disabilities and (c) an acceptable individual ODI score level compared to the external measures. Longitudinal external construct validity showed moderate correlations (range 0.56–0.78). We conclude that the Danish version of the ODI is both a valid and reliable outcome instrument in two LBP patient populations. The ODI is probably most appropriate for use in SeS patients.Part 2 of this article is available at:     

Responsiveness of the Oswestry Disability Index and the Roland Morris Disability Questionnaire in Italian subjects with sub-acute and chronic low back pain

Introduction  

An ability to assess longitudinal changes in health status is crucial for the outcome measures used in treatment efficacy trials. The aim of this study was to verify the responsiveness of the Italian versions of the Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) in subjects with subacute or chronic low back pain (LBP).     

Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI)

Purpose

To translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP).

Methods

A total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875–880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521–526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211–1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month.

Results

The floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54–0.72) with the corresponding questionnaires except for “symptom-specific well-being” (0.31–0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85–0.94) and 0.81–0.86 for the two pain scores (back and leg). The “minimum detectable change’’ (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score.

Conclusion

The Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China.     

Responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index in subjects with low back pain

When quality of life questionnaires are used as measures of treatment outcomes, it is essential to know how well these can respond to clinical changes. The objective of this study is to examine the responsiveness of the Brazilian–Portuguese version of the Oswestry Disability Index (ODI-Brazil) in subjects with chronic low back pain submitted to a physical therapy program. Thirty subjects with chronic low back pain completed the ODI-Brazil questionnaire, along with an 11-point pain visual analogue scale (Pain VAS), and the Brazilian–Portuguese version of Roland–Morris disability questionnaire before and after the program. All patients also completed a global perception of change Likert scale in condition after the program. This scale was collapsed to produce a dichotomous variable outcome: improved and non-improved. Responsiveness was determined using effect size statistics and receiver operating characteristic curve (ROC curve), with best cut-point analysis. The best change score cut-off was identified when equally balanced sensitivity and specificity was found, as an expression of the minimum clinically important difference (MCID). After treatment, 19 patients considered themselves improved. Both the effect size (0.37) and the area under the ROC curve (0.73) for ODI-Brazil score in relation to global outcome after program indicated that the ODI-Brazil showed responsiveness. The ROC curve for ODI-Brazil was distributed at the upper corners of the diagonal line, indicating that the questionnaire presents discriminative ability. The best cut-off point for ODI-Brazil was approximately 4.45 points (63.2% sensitivity, 81.8% specificity). The Brazilian–Portuguese version of ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in chronic low back pain patients receiving conservative care.     

One-year follow-up results of intradiscal diode laser,radiofrequency, and pulsed radiofrequency therapies: a retrospective study

This study aims to investigate the efficacy of three different percutaneous intradiscal therapies in patients with chronic low back pain (CLBP) due to lumbar disc herniation (LDH). Medical files of a total of 120 patients who received percutaneous intradiscal therapy were retrospectively analyzed. All patients were divided into three groups: group L: diode laser (n?=?40), group R: radiofrequency (RF) (n?=?40), and group P: pulsed radiofrequency (PRF) (n?=?40). The visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were calculated at 1, 3, 6, and 12 months for all patients. One-year follow-up results were as follows: group L: pre-treatment (PreT) VAS 5.6?±??1, ODI 37.6?±??4.7, post-treatment 12th month (PT12) VAS 2.8?±??1.4, ODI 14.1?±??7.1; group P: PreT VAS 6.0?±?1, ODI 37.5?±?5.9, PT12 VAS 3.1?±?1.3, ODI 20.3?±?17.0; and group R: PreT VAS 5.6?±?1.0, ODI 37.9?±?4.7, PT12 VAS 3.3?±?1.4, ODI 27.2?±?14.1. In each of the three groups, there was a statistically significant reduction in the VAS and ODI scores at 1, 3, 6, and 12 months, compared to the baseline values (p?<?0.05). The highest reduction in the VAS and ODI scores was observed in group L, whereas the lowest reduction was in group R. We consider that in groups with patient selection criteria at our study; diode laser, RF, and PRF, which are administered using the percutaneous intradiscal route for CLBP patients diagnosed with LDH, may be used as an alternative treatment option.     

Danish version of the Oswestry disability index for patients with low back pain. Part 2: Sensitivity, specificity and clinically significant improvement in two low back pain populations

In studies evaluating the efficacy of clinical interventions, it is of paramount importance that the functional outcome measures are responsive to clinically relevant change. Knowledge thereof is in fact essential for the choice of instrument in clinical trials and for clinical decision-making. This article endeavours to investigate the sensitivity, specificity and clinically significant improvement (responsiveness) of the Danish version of the Oswestry disability index (ODI) in two back pain populations. Two hundred and thirty three patients with low back pain (LBP) and/or leg pain completed a questionnaire booklet at baseline and 8 weeks follow-up. Half of the patients were seen in the primary (PrS) and half in the secondary sectors (SeS) of the Danish Health Care System. The booklet contained the Danish version of the ODI, along with the Roland Morris Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. At follow-up, a 7-point transition question (TQ) of patient perceived change and a numeric rating scale relating to the importance of the change were included. Responsiveness was operationalised using three strategies: change scores, standardised response means (SRM) and receiver operating characteristic (ROC) analyses. All methods revealed acceptable responsiveness of the ODI in the two patient populations which was comparable to the external instruments. SRM of the ODI change scores at 2 months follow-up was 1.0 for PrS patients and 0.3 for SeS (raw and percentage). A minimum clinically important change (MCID) from baseline score was established at 9 points (71%) for PrS patients and 8 points (27%) for SeS patients using ROC analyses. This was dependable on the baseline entry score with the MCID increasing with 5 points for every 10 points increase in the baseline score. We conclude that the Danish version of the ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in low back pain patients receiving conservative care in both the primary and secondary sector.     

Clinical assessment of a CMC/PEO gel to inhibit postoperative epidural adhesion formation after lumbar discectomy: a randomized, control study

Purpose

To evaluate effectiveness of carboxymethylcellulose/polyethylene oxide (CMC/PEO) gel in improving clinical outcomes after the first-time lumbar discectomy.

Method

Ninety-three patients with herniated lumbar disc at L4–L5 or L5–S1 were enrolled and randomized into two groups: CMC/PEO gel treatment group and control group. All the patients underwent laminotomy and discectomy by posterior approach. The preoperative and postoperative Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) scores for lower-back pain and leg pain were analyzed and compared between two groups at 30- and 60-day time points.

Results

No patient presented with any clinically measurable adverse event during surgery. There were no significant differences between the treated group and the control group on the preoperative ODI and VAS scores. In general, the ODI and VAS scores decreased in both groups at all the time points. At the 30-day time point, the VAS scores for back pain and leg pain and the ODI scores in treatment group were lower by 9.9 % (P = 0.0302), 27.0 % (P = 0.0002) and 16.3 % (P = 0.0007) than those in control group. And at the 60-day time point, the ODI and VAS scores further decreased in both groups. The VAS scores for leg pain in treatment group were lower by 4.5 % than that in the control group (P = 0.0149). However, no significant difference was detected between two groups on the ODI and VAS scores for back pain.

Conclusions

The results demonstrated that CMC/PEO gel is effective in reducing posterior dural adhesions in the spine with no apparent safety issues. It can improve patients’ postoperative clinical outcome.     

Back pain and disability after lumbar laminectomy: is there a relationship to muscle retraction?

OBJECTIVE: Preliminary studies have suggested that prolonged retraction of the paraspinal muscle during spinal surgery may produce ischemic damage. We report the continuous measurement of intramuscular pressure (IMP) during decompressive lumbar laminectomy and its relationship to subsequent back pain and disability. METHODS: Twenty patients undergoing two-level decompressive lumbar laminectomy for lumbar canal stenosis were recruited. Back pain and disability were assessed by use of the Visual Analog Score (VAS), Oswestry Disability Index (ODI), and Short-Form 36 (SF-36) Health Survey. During surgery, IMP was recorded continuously from the multifidus muscle by use of a pressure transducer. The intramuscular perfusion pressure (IPP) was estimated as the difference between the patient's mean arterial pressure and IMP. RESULTS: Two muscle retractors were used: the Norfolk and Norwich (n = 10) and the McCulloch (n = 10). The mean duration of deep muscle retraction was 62.7 +/- 8 minutes (range, 19-133 min). On application of deep muscle retraction, there was a rapid and sustained increase in IMP (P < 0.001), and overall, the calculated mean IPP approached 0 mm Hg or less during this period (P < 0.001). On release of deep muscle retraction, there was a rapid decrease in IMP to preoperative levels. The IPP was greater with the Norfolk and Norwich than the McCulloch retractor (P < 0.001). Compared with preoperative values, there was a decrease in ODI (P < 0.001) and VAS for back pain (P < 0.001) at discharge and 4 to 6 weeks and 6 months after surgery. In addition, there was a decrease in SF-36 scores at 6 months compared with preoperative values (P < 0.001). Total duration of muscle retraction greater than 60 minutes was associated with worse VAS scores for back pain and ODI and SF-36 scores for disability at 6 months after surgery (P < 0.05). There was no relationship between the VAS, ODI, and SF-36 scores and other parameters measured, including the mean IPP, retractor type, operating surgeon, and wound length. CONCLUSION: The McCulloch retractor generates a higher IMP than the Norfolk and Norwich retractor. However, postoperative improvement in VAS, ODI, and SF-36 scores in these patients was associated with a shorter duration of muscle retraction and not the degree of IMP or IPP generated. In this respect, periodic relaxation of the paraspinal muscle retractors during surgery to allow muscle perfusion may help to reduce postoperative back pain and disability.     

Responsiveness of the Chinese version of the Oswestry disability index in patients with chronic low back pain

The Oswestry Disability Index (ODI) is one of the most widely used questionnaires that assess disability in patients with low back pain (LBP). Responsiveness is both an important psychometric property of an instrument and a key issue for clinicians when choosing suitable outcome measures. The objective of this study was to examine the responsiveness of the Chinese version of the ODI (ODI-Chinese) for subjects with chronic LBP following a physical therapy program. In total, 76 patients with chronic LBP completed the ODI-Chinese, a visual analog scale (VAS) of pain, and the Chinese version of Short Form-36 (SF-36) before and after treatment. All patients also completed a global perception of change Likert scale in condition after the program. The scale was collapsed to produce a dichotomous variable outcome, improved or non-improved. The responsiveness of the instruments was determined using the standardized response means (SRM) and receiver operating characteristics (ROC). After treatment, 56 patients considered themselves to be improved. The SRM of the ODI-Chinese was −1.2 in the improved group and −0.4 in the non-improved group. The area of the ROC curve for the ODI-Chinese was 0.77 (95% CI 0.66–0.89). Therefore, the Chinese version of the ODI is both responsive and appropriate for use in chronic LBP patients after conservative therapy.     

Reliability and validity of Punjabi version of Oswestry Disability Index in patients with mechanical low back pain

ObjectiveOswestry disability Index(ODI) is the commonest patient reported outcome for assessment of disability due to low back pain. Its application to non-English speaking Punjabi population is limited as a validated and cross culturally adapted Punjabi version of ODI is not available. The purpose of the study was to analyse the psychometric properties of Punjabi version of Oswestry disability index (ODI-P) in patients with mechanical low back pain.Materials and methodsThe translation and cross-cultural adaptation of Punjabi version of ODI was done according to well recommended guidelines. The prefinal version was tested on a set of 15 patients and suitable modifications were made. The final version was administered to 113 patients with mechanical low back pain of more than two weeks duration. Psychometric properties comprising of internal consistency, test retest reliability, floor and ceiling effect, construct validity and factorial structure of the questionnaire were determined.ResultsODI-P showed excellent internal consistency (Chronbach alpha of ODI-P is 0.72), test retest reliability (ICC 0.891) and construct validity (Spearman correlation coefficient with VAS 0.424). Factor analysis proved the questionnaire to be having a 1-factor structure with a total variance of 48.61%.ConclusionsODI (P) is a reliable and valid instrument for measurement of disability related to mechanical low back pain in Punjabi population. It can be used both in research and clinical care settings in future.     

The influence of hand grip strength on surgical outcomes after surgery for degenerative lumbar spinal stenosis: a preliminary result

Background Context

Although a number of prognostic factors have been demonstrated to be associated with surgical outcome of degenerative lumbar spinal stenosis (DLSS), no study has investigated the relation between hand grip strength (HGS) and treatment outcome of DLSS.

Neck and back pain specific outcome assessment questionnaires in the Spanish language: a systematic literature review

Background contextAccurate measurement of functional improvement in clinical practice is becoming increasingly recognized as essential in demonstrating whether patients are deriving meaningful benefit from care. Several simple questionnaires have been developed for this purpose. The majority of these have been developed in English. In North America, there is a growing need for clinical tools, including outcome assessment tools that are available in the Spanish language.PurposeThe purpose of this study was to systematically review the literature regarding spine-specific outcome assessment questionnaires that are available in Spanish and to examine the evidence on their clinical utility.Study designSystematic review.MethodsThe Medline, CINAHL, Embase, and MANTIS databases were searched for any studies on the topic of outcome assessment questionnaires in the Spanish language. Relevant articles were reviewed, and the data on reliability, validity, time to completion, and any other properties of the questionnaire was extracted.ResultsThe search strategy identified 287 articles, of which 10 were deemed relevant. With regard to neck pain, data were found regarding Spanish translations of the Northwick Park Neck Pain Questionnaire, Neck Disability Index (NDI), and Core Outcome Measure for neck pain. With regard to low back pain, data were found regarding Spanish translations of the Oswestry Low Back Pain Disability Index (ODI), Roland Morris Disability Questionnaire (RMQ), and the North American Spine Society—American Academy of Orthopedic Surgeons questionnaire.ConclusionsSeveral reliable and valid outcome assessment questionnaires are available in the Spanish language. All were originally developed in English. It appears from the data reviewed that the most useful instruments are the NDI for neck pain patients and the ODI and RMQ for low back pain patients. The current trend is for the development of culturally adapted versions of these questionnaires that are specific to a particular country or region.     

Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language

Purpose

The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI.

Methods

A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (>3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7–10 days to assess reproducibility.

Results

The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain ‘function’, 96% for ‘symptom-specific well-being’, 97% for ‘general quality of life’, 99% for ‘social disability’ and 100% for ‘work disability’. The intraclass correlation coefficients (ICC_2,1) for COMI pain and COMI summary scores were 0.91–0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a “minimum detectable change” (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered “real change” beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4–0.8) with the other symptom-specific questionnaires.

Conclusions

The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.     

Italian version of the Roland Disability Questionnaire,specific for low back pain: cross-cultural adaptation and validation

Over the last 10 years, patient-oriented evaluations using questionnaires have become an important aspect of clinical spinal outcome studies. Any questionnaire must be translated and culturally adapted in order to be used with different language groups, and the translated version must then be evaluated for reliability and validity, which are fundamental attributes of any measurement tool. The Roland Disability Questionnaire, a low back pain disease-specific tool, was submitted to translation into Italian and to cross-cultural adaptation following the Guillemin criteria. It was then validated on 70 patients (37 male and 33 female; mean age 58, range: 28-67) suffering from low back pain as assessed by clinical examination, imaging and also electromyography in cases of suspected neurological impairment. The test-retest reliability, assessed with intraclass correlation, was 0.92 and the internal consistency reached a Cronbach's alpha of 0.82. The Italian version of the Roland Disability Questionnaire satisfied the validation criteria, showing characteristics of reliability and validity similar to previously published versions translated and adapted for other countries.     

Effectiveness and safety of extracorporeal shock wave treatment for low back pain：a systematic review and meta-analysis of RCTs

This meta-analysis was designed to assess the effectiveness and safety of extracorporeal shock wave therapy (ESWT) for patients with low back pain (LBP). Pubmed, Embase, Cochrane's library, PEDro (Physiotherapy Evidence Database), China National Knowledge Infrastructure (CNKI), and Wanfang Data were searched until December 2019 to identify studies assessing the effectiveness and safety of EPSW for LBP. The prime outcome is pain intensity measured by Visual Analog Scale (VAS) or numeric rating scale (NRS). Other outcomes included functional status, quality of life, psychological outcomes measured by Oswestry Disability Index (ODI), as well as the adverse events. Mean differences (MD) were calculated for continuous outcomes, while odd ratios (OR) were calculated for binary outcomes. Revman 5.3 software was used for statistical analysis. Five randomized controlled trials (RCTs) were finally included in this meta-analysis. The pooled mean difference in post-treatment pain scores was −2.37 (P ＜0.0001), indicating that post-treatment pain scores was significantly higher by 2.37 in control group than in ESWT group. At a mean follow-up time of 4–6 weeks, the pooled mean difference in ODI scores was −14.10 (P ＜0.00001), indicating that the pooled mean difference of post-treatment ODI scores was 14.10 higher in control group than in ESWT group. The use of ESWT is effective in alleviating pain and improving the general functional state for patients with LBP. However, more evidence was needed to verify its safety.     

Low back pain: critical assessment of various scales

To study the various pain assessment tools based on their psychometric properties and ease of use. Published articles on psychometric properties of pain tools were accessed and data collected for low back pain (LBP)-specific tools, generic tools, neuropathic LBP tools, tools for cognitively impaired patients, and tools for acute LBP. Among the LBP-specific tools, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI) have good construct validity and reliability, and responsiveness over short intervals. Quebec Back Pain Disability Scale (QBPDS) gauges only disability and sleep. Among the generic tools, McGill Pain Questionnaire (MPQ), West Haven-Yale Multidimensional Pain Inventory (MPI), and Brief Pain Inventory (BPI) show good responsiveness, but BPI is the only tool validated for LBP. Neuropathic Pain Scale (NPS) and Short Form-MPQ-2 (SF-MPQ-2) are both reliable tools for neuropathic LBP. For cognitively impaired patients, Pain Assessment in Advanced Dementia (PAINAD), Abbey Pain Scale (APS), and Doloplus-2 are all reliable tools, but PAINAD has good construct validity. For acute pain, Clinically Aligned Pain Assessment (CAPA) is reliable and responsive, but presently, unidimensional tools and SF-MPQ-2 are the tools most preferred. Based on psychometric properties and ease of use, the best tools for LBP seem to be RMDQ/ODI (among LBP-specific tools), BPI (among generic tools), SF-MPQ-2/NPS (for neuropathic LBP), PAINAD (for cognitively impaired patients), and unidimensional tools and SF-MPQ-2 (for acute pain). Overall, BPI seems to be a tool that can be relied upon the most. These slides can be retrieved under Electronic Supplementary Material.     

Clinical results of an open prospective study of a bis-GMA composite in percutaneous vertebral augmentation

In this open prospective trial, 53 patients with acute pain from osteoporotic vertebral fracture related to osteoporosis or malignancy underwent vertebral augmentation with a new bisphenol-a-glycidyl dimethacrylate (bis-GMA) resin (Cortoss, Orthovita, Malvern, Pa, USA). Treatment consisted of up to 8 ml of Cortoss injected into a given vertebra. The procedure encompassed single and multiple injections (including the contralateral hemivertebra, to a maximum of 3 vertebral levels). Follow-up was at 4 and 8 days and at 1, 3, and 6 months. The primary efficacy end point was patient-rated pain using a 100-point visual analog scale (VAS, with 100 as severest pain) on day 4 following treatment; secondary end points were analgesic use and quality-of-life and disability scores from the Oswestry Disability Index (ODI) and a short-form 12-item questionnaire (SF-12). The present report contains interim results collected up to the 1-month post-treatment time point. At baseline, the groups mean VAS score was 69, indicating moderate to severe pain; at day 4, 32 of 53 patients (60.4%) reported a 30% or greater reduction in baseline pain accompanied by a VAS pain score less than 50 (mean 38.1). Pain reduction was maintained at 1 month (mean VAS 31.3). The average ODI score at baseline was 55, suggesting significant disability among participants prior to Cortoss treatment. Following treatment, the ODI scores were significantly reduced from these baseline levels (day 8, 47.4; 1 month, 33.6). Further, SF-12 physical and mental component scores at 1 month after treatment increased from baseline by 26% and 11%, respectively; while analgesic use decreased concomitantly, primarily among patients with underlying osteoporosis. A total of 20 adverse events were deemed to be device-related. The most frequent clinically significant adverse events attributed to Cortoss were leakage of Cortoss from within the vertebral body at placement (12%), back pain (7%), and unspecified pain (7%). These results indicate that vertebral augmentation with Cortoss rapidly reduces pain, decreases disability, and improves physical functioning in patients with painful vertebral compression fractures.This work was funded by Orthovita Europe, Leuven, Belgium     

Does hybrid fixation prevent junctional disease after posterior fusion for degenerative lumbar disorders? A minimum 5-year follow-up study

Purpose

Medium- to long-term retrospective evaluation of clinical and radiographic outcome in the treatment of degenerative lumbar diseases with hybrid posterior fixation.

Methods

Thirty patients were included with the mean age of 47.8 years (range 35 to 60 years). All patients underwent posterior lumbar instrumentation using hybrid fixation for lumbar stenosis with instability (13 cases), degenerative spondylolisthesis Meyerding grade I (6 cases), degenerative disc disease of one or more adjacent levels in six cases and mild lumbar degenerative scoliosis in five patients. Clinical outcomes were evaluated using Oswestry disability index (ODI), Roland and Morris disability questionnaire (RMDQ), and the visual analog scale (VAS) pain scores. All patients were assessed by preoperative, postoperative and follow-up standing plain radiographs and lateral X-rays with flexion and extension. Adjacent disc degeneration was also evaluated by magnetic resonance imaging (MRI) at follow-up.

Results

At a mean follow-up of 6.1 years, we observed on X-rays and/or MRI 3 cases of adjacent segment disease (10.0 %): two of them (6.6 %) presented symptoms and recurred a new surgery. The last patient (3.3 %) developed asymptomatic retrolisthesis of L3 not requiring revision surgery. The mean preoperative ODI score was 67.6, RMDQ score was 15.1, VAS back pain score was 9.5, and VAS leg pain score was 8.6. Postoperatively, these values improved to 28.1, 5.4, 3.1, and 2.9, respectively, and remained substantially unchanged at the final follow-up: (27.7, 5.2, 2.9, and 2.7, respectively).

Conclusions

After 5-year follow-up, hybrid posterior lumbar fixation presented satisfying clinical outcomes in the treatment of degenerative disease.