Individualized quality of life in patients with low back pain: reliability and validity of the Patient Generated Index

Objective: To evaluate the reliability and validity of the improved version of the Patient Generated Index (PGI) in patients with low back pain. Methods: The PGI was administered to 90 patients attending care in 1 of 6 institutions in Norway and evaluated for reliability and validity. The questionnaire was given out to 61 patients for re-test purposes. Results: The PGI was completed correctly by 80 (88.9%) patients and, of the 61 patients responding to the re-test, 50 (82.0%) completed both surveys correctly. PGI scores were approximately normally distributed, with a median of 40 (range 80), where 100 is the best possible quality of life. There were no floor or ceiling effects. The 5 most frequently listed areas affecting quality of life were pain, sleep, stiffness, socializing and housework. The test-retest intraclass correlation coefficient was 0.73. The smallest detectable changes for individual and group purposes were 32.8 and 4.6, respectively. The correlations between PGI scores and other instrument scores followed a priori hypotheses of low to moderate correlations. Discussion: The PGI has evidence for reliability and validity in Norwegian patients with low back pain at the group level and may be considered for application in intervention studies when a comprehensive evaluation of quality of life is important. However, the smallest detectable change, of approximately 30 points, may be considered too large for individual purposes in clinical application

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term. Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration: ISRCTN: ISRCTN5871969

Rasch analysis of the 23-item version of the Roland Morris Disability Questionnaire

Objective: To determine the psychometric properties of the 23-item version of the Roland Morris Disability Questionnaire (RMDQ-23) and to quantify their stability across 2 cultures/languages and 2 types of care-settings. Methods: Rasch analysis of data from 1,000 patients with low back pain from primary care (UK and Denmark) and secondary care (Denmark). Results: The RMDQ-23 is unidimensional if local item dependency issues are accommodated, but contains several misfitting or overdiscriminating items, some poor targeting of items, and the scoring of 4-5 items is differentially affected by common clinical characteristics (such as age, gender, pain intensity, pain duration and care setting), depending on the country. Conclusion: As similar results have been found for the RMDQ-24, we believe it is timely to reconsider whether: (i) the RMDQ should be reconstructed using an item-response theory-based approach that includes consideration of new items and response options; or (ii) the use of alternative questionnaires should be recommended, such as the Oswestry Disability Index, that have shown evidence of fitting the Rasch model; or (iii) a completely new condition-specific questionnaire should be developed, perhaps utilizing a computerized adaptive testing platform

T2 Values of Posterior Horns of Knee Menisci in Asymptomatic Subjects

[[abstract]]Purpose: The magnetic resonance (MR) T2 value of cartilage is a reliable indicator of tissue properties and therefore may be used as an objective diagnostic tool in early meniscal degeneration. The purpose of this study was to investigate age, gender, location, and zonal differences in MR T2 value of the posterior horns of knee menisci in asymptomatic subjects. Methods: Sixty asymptomatic volunteers (30 men and 30 women) were enrolled and divided into three different age groups: 20–34, 35–49 and 50–70 years. The inclusion criteria were BMI＜30 kg/cm2, normalized Western Ontario and McMaster Universities (WOMAC) pain score of zero, and no evidence of meniscal and ligamentous abnormalities on routine knee MR imaging. The T2 values were measured on images acquired with a T2-weighted fat-suppressed turbo spin-echo sequence at 3T. Results: The mean T2 values in both medial and lateral menisci for the 20–34, 35–49, and 50–70 age groups were 9.94 msec±0.94, 10.73 msec±1.55, and 12.36 msec±2.27, respectively, for women and 9.17 msec±0.74, 9.64 msec±0.67, and 10.95 msec±1.33, respectively, for men. The T2 values were significantly higher in the 50–70 age group than the 20–34 age group (P＜0.001) and in women than in men (P = 0.001, 0.004, and 0.049 for each respective age group). T2 values were significantly higher in medial menisci than in lateral menisci only in women age 50–70 (3.33 msec, P = 0.006) and in the white zone and red/white zone of the 50–70 and 35–49 age groups than that of the 20–34 age group (2.47, 1.02; 2.77, 1.16 msec, respectively, all P＜0.01). Conclusion: The MR T2 values of the posterior meniscal horns increase with increasing age in women and are higher in women than in men. The age-related rise of T2 values appears to be more severe in medial menisci than in lateral menisci. Differences exist in the white zone and red/white zone.[[incitationindex]]SCI[[booktype]]電子

Prognosis of sciatica and back-related leg pain in primary care: the ATLAS cohort

BACKGROUND CONTEXT: Evidence is lacking on the prognosis and prognostic factors of back-related leg pain and sciatica in patients seeing their primary care physicians. This evidence could guide timely appropriate treatment and referral decisions. PURPOSE: The present study aims to describe the prognosis and prognostic factors in primary care patients with low back-related leg pain and sciatica. STUDY DESIGN: This is a prospective cohort study. PATIENT SAMPLE: The present study included adults visiting their family doctor with back-related leg pain in the United Kingdom. OUTCOME MEASURES: Information about pain, function, psychological, and clinical variables, was collected. Good outcome was defined as 30% or more reduction in disability (Roland-Morris Disability Questionnaire). METHODS: Participants completed the questionnaires, underwent clinical assessments, received a magnetic resonance imaging scan, and were followed-up 12 months later. Mixed-effects logistic regression evaluated the prognostic value of six a priori defined variable sets (leg pain duration, pain intensity, neuropathic pain, psychological factors, clinical examination, and imaging variables). A combined model, including variables from all models, examined independent effects. The National Institute for Health Research funded the study. There are no conflicts of interest. RESULTS: A total of 609 patients were included. At 12 months, 55% of patients improved in both the total sample and the sciatica group. For the whole cohort, longer leg pain duration (odds ratio [OR] 0.41; confidence interval [CI] 0.19-0.90), higher identity score (OR 0.70; CI 0.53-0.93), and patient's belief that the problem will last a long time (OR 0.27; CI 0.13-0.57) were the strongest independent prognostic factors negatively associated with improvement. These last two factors were similarly negatively associated with improvement in the sciatica subgroup. CONCLUSIONS: The present study provides new evidence on the prognosis and prognostic factors of back-related leg pain and sciatica in primary care. Just over half of patients improved at 12 months. Patient's belief of recovery timescale and number of other symptoms attributed to the pain are independent prognostic factors. These factors can be used to inform and direct decisions about timing and intensity of available therapeutic options

The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies.

BACKGROUND: Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. METHODS: Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). RESULTS: 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). CONCLUSIONS: The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared 'natural history', enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design

Stratifying workers on sick leave due to musculoskeletal pain: translation, cross-cultural adaptation and construct validity of the Norwegian Keele STarT MSK tool

Objectives: Stratified care using prognostic models to estimate the risk profiles of patients has been increasing. A refined version of the popular STarT Back tool, the Keele STarT MSK tool, is a newly developed model for matched treatment across a wide range of musculoskeletal pain presentations. The aim of this study was to translate and culturally adapt the Keele STarT MSK tool into Norwegian, examine its construct validity and assess the representativeness of the included sample. Methods: The Keele STarT MSK tool was formally translated into Norwegian following a multistep approach of forward and backward translation. A pre-final version was tested in 42 patients. Minor changes were implemented. To assess its construct validity, an online survey was conducted among workers aged 18-67 years who were on sick leave (>4 weeks) due to musculoskeletal disorders. Construct validity was evaluated in terms of convergent and discriminant validity using Pearson’s correlation coefficient, and known-group validity by comparing risk subgroups as suggested by the COSMIN checklist. The representativeness of the sample was assessed by comparing demographic and sick leave information of participants to eligible non-participants (n=168 137). Results: A representative sample of 549 workers participated in the validity assessment; 74 participants (13.5%) were categorised as low risk, 314 (57.2%) as medium risk and 161 (29.3%) as high risk. The construct validity was found sufficient, with 90.9% and 75.0% of the pre-defined hypotheses confirmed for convergent and discriminant validity, and known-group validity, respectively. Floor or ceiling effects were not found. Conclusions: The Keele STarT MSK tool was successfully translated into Norwegian. The construct validity of the tool was acceptable in a representative cohort of workers on sick leave as a result of musculoskeletal pain. However, the analyses raised concerns as to whether one of the questions captures the construct it is intended to measure.publishedVersio

Responsiveness and Minimal Important Change for Pain and Disability Outcome Measures in Pregnancy-Related Low Back and Pelvic Girdle Pain.

BACKGROUND: Pregnancy-related low back pain and pelvic girdle pain (LBP/PGP) are common and negatively impact the lives of many pregnant women. Several patient-based outcome instruments measure treatment effect but there is no consensus about which measure to use with women who have these pain presentations. OBJECTIVE: The objective was to compare the responsiveness of 3 outcome measures in LBP/PGP: Oswestry Disability Index-version 2.0 (ODI), Pelvic Girdle Questionnaire (PGQ), and 0-10 numerical rating scale for pain severity (NRS); and to estimate a minimal important change (MIC) for these measures in pregnancy-related LBP/PGP. DESIGN: This was a methodology study using data from a pilot randomised trial (RCT). METHODS: Women (n = 124) with pregnancy-related LBP/PGP were recruited to a pilot RCT evaluating the benefit of adding acupuncture to standard care and 90 completed 8-weeks follow-up. Responsiveness was evaluated by examining correlation between change score and the external anchor (6-point global perceived effect scale) and by using receiver operating characteristic (ROC) curve analysis. MIC was estimated using anchor-based methods. RESULTS: All measures showed good responsiveness, with areas under ROC curve ranging from 0.77 to 0.90. The estimated MICs were 3.1, 11.0, 9.4, 13.3, and 1.3 for ODI, PGQ-total, PGQ-activity, PGQ-symptoms, and NRS, respectively. All the measures, apart from ODI, had MICs larger than the measurement error. LIMITATIONS: Lack of optimal "gold standard" or external criterion for assessing responsiveness and MIC was a limitation of this study. CONCLUSION: All 3 outcome measures demonstrated good responsiveness. MICs were derived for each instrument. The PGQ at 8 weeks post-randomisation was identified as an appropriate outcome measure for pregnancy-related LBP/PGP since it is specific to these pain presentations and assesses both activity limitations and symptoms. The NRS is an efficient, shorter alternative

Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-speficic sub-acute low back pain in the working population : cluster randomised trial

Background: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. Methods/Design: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. Discussion: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres

The COPE LBP trial: Cognitive Patient Education for Low Back Pain - a cluster randomized controlled trial in primary care

<p>Abstract</p> <p>Background</p> <p>Non-specific low back pain (LBP) is usually self-limiting within 4-6 weeks. Longstanding pain and disability are not predictable from clinical signs or pathoanatomical findings. Pain cognition and physical performance have been shown to improve patients with chronic LBP following neurophysiological education. The primary aim of this study is to evaluate whether a specific cognitive based education programme for patients with LBP in primary care is more effective than normal care in terms of increased function. The secondary aims of the study are to evaluate whether this intervention also results in earlier return to work, decreased pain, increased patient satisfaction, increased quality-of-life, and cost utility.</p> <p>Methods/Design</p> <p>Cluster randomised controlled trial with 20 general practitioners and 20 physiotherapists in primary care as the unit of randomisation. Each practitioner will recruit up to 10 patients, aged 20 to 55 years, with non-specific sub-acute/chronic LBP of more than four weeks but less than 1 year's duration. Practitioners in the intervention arm will provide cognitive patient education intervention in up to four weekly sessions, each lasting 30 minutes. Practitioners in the control arm will provide normal treatment, but have to make four appointments for the patients. Patients, outcome assessors, and study statistician will be blinded to group allocation.</p> <p>Discussion</p> <p>We present the rationale and design of an ongoing RCT study that potentially offers an easily implemented treatment strategy for LBP patients in primary care. The results will be available in 2012.</p> <p>Trial registration</p> <p>ISRCTN04323845</p