Development of a German version of the Oswestry Disability Index. Part 1: cross-cultural adaptation, reliability, and validity

Patient-orientated assessment methods are of paramount importance in the evaluation of treatment outcome. The Oswestry Disability Index (ODI) is one of the condition-specific questionnaires recommended for use with back pain patients. To date, no German version has been published in the peer-reviewed literature. A cross-cultural adaptation of the ODI for the German language was carried out, according to established guidelines. One hundred patients with chronic low-back pain (35 conservative, 65 surgical) completed a questionnaire booklet containing the newly translated 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 [to assess ODI's construct (convergent) validity]. Thirty-nine of these patients completed a second questionnaire within 2 weeks (to assess test-retest reliability). The intraclass correlation coefficient for the test-retest reliability of the questionnaire was 0.96. In test-retest, 74% of the individual questions were answered identically, and 21% just one grade higher or lower. The standard error of measurement (SEM) was 3.4, giving a "minimum detectable change" (MDC(95%)) for the ODI of approximately 9 points, i.e. the minimum change in an individual's score required to be considered "real change" (with 95% confidence) over and above measurement error. The ODI scores correlated with VAS pain intensity (r = 0.78, P < 0.001) and Roland Morris scores (r = 0.80, P < 0.001). The mean baseline ODI scores differed significantly between the surgical and conservative patients (P < 0.001), and between the different categories of the Likert scales for disability, medication use and pain frequency (in each case P < 0.001). Our German version of the Oswestry questionnaire is reliable and valid, and shows psychometric characteristics as good as, if not better than, the original English version. It should represent a valuable tool for use in future patient-orientated outcome studies in German-speaking lands.     

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.     

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.     

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.     

Oswestry功能障碍指数评定腰痛患者的可信性

目的 :探讨Oswestry功能障碍指数 (OswestrydisabilityIndex ,ODI)应用于腰痛患者评定的可信性。 方法 :住院拟手术的腰痛患者 2 2例 (男 13,女 9例 ) ,分为同一检查者重复评定 (A组 ) :10例 ,平均年龄 4 7 7岁 ;不同检查者重复评定 (B组 ) ,12例 ,平均年龄 36 6岁。用ODI对所有对象重复评定 ,平均间隔 3 0d。对两组患者的障碍指数进行Pearson相关分析。结果 :两组重复测试ODI的相关系数分别为 0 95 3和 0 912 ,相关性非常显著 (A组 :t =8 85 1,P <0 0 0 1;B组 :t=7 0 0 8,P <0 .0 1)。结论 :用ODI评定腰痛是稳定、可靠的 ,可作为腰痛患者是否需要手术或康复疗效评定的参考指标。     

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 Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders

BACKGROUND CONTEXT

The Patient-Reported Outcomes Information System (PROMIS) instruments are an important advancement in the use of PROs, but need to be evaluated with longitudinal data to determine whether they are responsive to change in specific clinical populations.

Oswestry Disability Index is a better indicator of lumbar motion than the Visual Analogue Scale

Background contextLumbar pathology is often associated with axial pain or neurologic complaints. It is often presumed that such pain is associated with decreased lumbar motion; however, this correlation is not well established. The utility of various outcome measures that are used in both research and clinical practice have been studied, but the connection with range of motion (ROM) has not been well documented.PurposeThe current study was performed to assess objectively the postulated correlation of lumbar complaints (based on standardized outcome measures) with extremes of lumbar ROM and functional ROM (fROM) with activities of daily living (ADLs) as assessed with an electrogoniometer.Study design/settingThis study was a clinical cohort study.Patient sampleSubjects slated to undergo a lumbar intervention (injection, decompression, and/or fusion) were enrolled voluntarily in the study.Outcome measuresThe two outcome measures used in the study were the Visual Analogue Scale (VAS) for axial extremity, lower extremity, and combined axial and lower extremity, as well as the Oswestry Disability Index (ODI).MethodsPain and disability scores were assessed with the VAS score and ODI. A previously validated electrogoniometer was used to measure ROM (extremes of motion in three planes) and fROM (functional motion during 15 simulated activities of daily living). Pain and disability scores were analyzed for statistically significant association with the motion assessments using linear regression analyses.ResultsTwenty-eight men and 39 women were enrolled, with an average age of 55.6 years (range, 18–79 years). The ODI and VAS were associated positively (p<.001). Combined axial and lower extremity VAS scores were associated with lateral and rotational ROM (p<.05), but not with flexion/extension or any fROM. Similar findings were noted for separately analyzed axial and lower extremity VAS scores. On the other hand, the ODI correlated inversely with ROM in all planes, and fROM in at least one plane for 10 of 15 ADLs (p<.05).ConclusionsExtremes of lumbar motion and motions associated with ADLs are of increasing clinical interest. Although the ODI and VAS are associated with each other, the ODI appears to be a better predictor of these motion parameters than the VAS (axial extremity, lower extremity, or combined) and may be more useful in the clinical setting when considering functional movement parameters.     

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.     

Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes

BACKGROUND CONTEXT: Although numerous studies have been published, controversy still exists regarding fusion and nonsurgical treatment for symptomatic degenerative lumbar spine conditions. Definite conclusions are difficult to draw because of differences in patient inclusion criteria, fusion technique, nonoperative treatment regimen, and clinical outcome measures used to determine success. PURPOSE: The objective of this study was to evaluate lumbar fusion and nonsurgical interventions for various degenerative spine disorders using the Oswestry Disability Index (ODI) as a primary outcome measure in a systematic review. A secondary objective was to determine whether there is a difference in clinical outcomes based on the specific diagnosis. STUDY DESIGN/SETTING: Systematic review. PATIENT SAMPLE: Patients with low back pain of at least 12 weeks duration and older than 18 years, with prospectively collected ODI scores and at least a 12-month follow-up. OUTCOME MEASURES: ODI and Short Form-36 (SF-36). METHODS: A MEDLINE, HealthSTAR, CINAHL, and Cochrane database search was done using the search strategy recommended by the Cochrane Back Review Group. Proceedings from annual meetings of various spine societies and reference lists from review articles and retrieved articles were evaluated for possible inclusion. Criteria for inclusion were prospective randomized clinical trials in patients with low back pain of at least 12 weeks duration and older than 18 years; with prospectively collected ODI scores and at least a 12-month follow-up. The methodological quality of the studies was assessed using the van Tulder criteria. Data extracted from each study included demographics, study design, diagnosis, baseline and change in ODI, and baseline and change in SF-36 Physical Composite Score (PCS). The data were pooled and analyzed based on the primary reported inclusion diagnosis: degenerative disc disease (DDD), chronic low back pain (CLBP), and spondylolisthesis; and treatment: fusion (unspecified, posterior, anterior, combined) and nonsurgical. RESULTS: Twenty-five studies met the inclusion criteria. The distribution of sex and smokers was similar across diagnoses and treatments. Patients with spondylolisthesis were older than patients with DDD and CLBP. Patients with spondylolisthesis had the greatest ODI improvement followed by patients with DDD and CLBP. The three fusion types produced similar amounts of improvement in ODI. Nonsurgical patients did not improve as much but had a lower baseline ODI. Improvements in the SF-36 PCS were fairly consistent across diagnostic groups and treatment types. CONCLUSIONS: Substantial improvement can be expected in patients treated with fusion, regardless of technique, when an established indication such as spondylolisthesis or DDD exists. CLBP patients are less disabled and experience less improvement.     

Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango

Spine Tango is the first and only International Spine Registry in operation to date. So far, only surgical spinal interventions have been recorded and no comparable structured and comprehensive documentation instrument for conservative treatments of spinal disorders is available. This study reports on the development of a documentation instrument for the conservative treatment of spinal disorders by using the Delphi consensus method. It was conducted with a group of international experts in the field. We also assessed the usability of this new assessment tool with a prospective feasibility study on 97 outpatients and inpatients with low back or neck pain undergoing conservative treatment. The new ‘Spine Tango conservative’ questionnaire proved useful and suitable for the documentation of pathologies, conservative treatments and outcomes of patients with low back or neck problems. A follow-up questionnaire seemed less important in the predominantly outpatient setting. In the feasibility study, between 43 and 63% of patients reached the minimal clinically important difference in pain relief and Core Outcome Measures Index at 3 months after therapy; 87% of patients with back pain and 85% with neck pain were satisfied with the received treatment. With ‘Spine Tango conservative’ a first step has been taken to develop and implement a complementary system for documentation and evaluation of non-surgical spinal interventions and outcomes within the framework of the International Spine Registry. It proved useful and feasible in a first pilot study, but it will take the experience of many more cases and therapists to develop a version similarly mature as the surgical instruments of Spine Tango.     

Return to work following surgery for lumbar radiculopathy: a systematic review

Background Context

Informing patients about postoperative return to work (RTW) expectations is of utmost importance because of the influence of realistic expectations on RTW outcomes.

Dynamic stabilization adjacent to single-level fusion: Part I. Biomechanical effects on lumbar spinal motion

Progression of superior adjacent segment degeneration (PASD) could possibly be avoided by dynamic stabilization of an initially degenerated adjacent segment (AS). The current study evaluates ex vivo the biomechanics of a circumferential fixation connected to posterior dynamic stabilization at the AS. 6 human cadaver spines (L2–S1) were stabilized stepwise through the following conditions for comparison: intact spine (ISP), single-level fixation L5–S1 (SLF), SLF + dynamic AS fixation L4–L5 (DFT), and two-level fixation L4–S1 (TLF). For each condition, the moments required to reach the range of motion (ROM) of the intact whole spine segment under ±10 Nm (WSP10) were compared for all major planes of motion within L2–S1. The ROM at segments L2/3, L3/4, and L4/5 when WSP10 was applied were also compared for each condition. The moments needed to maintain WSP10 increased with each stage of stabilization, from ISP to SLF to DFT to TLF (p < 0.001), in all planes of motion within L2–S1. The ROM increased in the same order at L3/4 (extension, flexion, and lateral bending) and L2/3 (all except right axial rotation, left lateral bending) during WSP10 application with 300 N axial preload (p < 0.005 in ANOVA). At L4/5, while applying WSP10, all planes of motion were affected by stepwise stabilization (p < 0.001): ROM increased from ISP to SLF and decreased from SLF to DFT to TLF (partially p < 0.05). The moments required to reach WSP10 increase dependent on the number of fixated levels and the fixation stiffness of the implants used. Additional fixation shifts motion to the superior segment, according to fixation stiffness. Therefore, dynamic instrumentation cannot be recommended if prevention of hyper-mobility in the adjacent levels is the main target.     

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.

Computed tomography for the diagnosis of lumbar spinal pathology in adult patients with low back pain or sciatica: a diagnostic systematic review

Aim  

In low back pain if serious pathology is suspected diagnostic imaging could be performed. One of the imaging techniques available for this purpose is computed tomography (CT), however, insight in the diagnostic performance of CT is unclear.     

Anesthesia for surgery related to craniosynostosis: a review. Part 2

The management of children with craniosynostosis is multidisciplinary and has evolved significantly over the past five decades. The treatment is primarily surgical. The anesthetic challenges continue to be the management of massive blood transfusion and prolonged anesthesia in small children, often further complicated by syndrome‐specific issues. This two‐part review aims to provide an overview of the anesthetic considerations for these children. The first part described the syndromes associated with craniosynostosis, the provision of services in the UK, surgical techniques, preoperative issues and induction and maintenance of anesthesia. This second part will explore hemorrhage control, the use of blood products, metabolic disturbance and postoperative issues.     

Three-dimensional stabilization provided by the external spinal fixator compared to two internal fixation devices: a biomechanical in vitro flexibility study

We performed an in vitro study to investigate the stabilization (i.e. motion reduction) provided by the external spinal fixator (ESF), and to compare the three configurations of the ESF with two internal fixation techniques. Six human cadaveric lumbar spine specimens (L3-S1) were subjected to multidirectional flexibility testing in six configurations: (1) intact, (2) ESF in neutral, (3) ESF in distraction, (4) ESF in compression, (5) translaminar facet screw fixation, and (6) internal transpedicular fixation. Both the ESF and the internal fixation systems stabilized the specimens from L4 to S1. In each testing configuration, pure bending moments of flexion-extension, bilateral axial rotation, and bilateral lateral bending were applied to the uppermost vertebra stepwise to a maximum of 10 Nm. The rigid body motion between the vertebrae was measured using an optoelectronic camera system, and custom software was used to calculate the intervertebral rotations. For each applied motion in all testing configurations, the total range of motion (ROM) of L4-S1 is reported. All three ESF configurations stabilized the spine significantly when compared to the intact specimen. The ESF in compression provided significantly more stabilization in flexion-extension than the two other ESF configurations, but no other significant differences were found between the three ESF modes. In flexion-extension the ESF stabilized the spine significantly when compared with the two internal fixation devices. Only in bilateral lateral bending was the ESF inferior to internal transpedicular fixation in providing stabilization. The results of the present study suggest that the ESF provides a high degree of stabilization for preoperative assessment of selected low back pain patients. Whether other non-mechanical factors affect the pain relief experienced by the patients remains unknown.     

Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature

The objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total disc replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the total disc replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial disc was non-inferior to the BAK^® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The Prodisc artificial disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the total disc replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.