Purpose
Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core ...outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
Methods
An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
Results
A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45 %. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Consensus on ‘physical functioning’ and ‘pain intensity’ was consistent across all stakeholders, ‘health-related quality of life’ was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain ‘number of deaths’.
Conclusions
The following outcome domains were included in this updated COS: ‘physical functioning’, ‘pain intensity’, ‘health-related quality of life’ and ‘number of deaths’. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
Low back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure ...and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds.
To review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term.
We searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review.
All studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds.
Two review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity.
From 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions.Sensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity.
Patients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR.
To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and ...health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.
To retrieve, appraise, and synthesize the results of studies on the prevalence of active and latent myofascial trigger points (MTrPs) in subjects with spinal pain disorders.
The databases PubMed, ...Embase, and CINAHL were searched, with no date or language restrictions. Search terms included controlled and free-text terms for spinal disorders and MTrPs. Further searches were conducted in Google Scholar and by contacting 3 experts in the field. Citation tracking of eligible studies was performed.
Two reviewers independently selected observational studies assessing the prevalence of active and/or latent MTrPs in at least 1 group of adults with a spinal disorder. Twelve studies met the eligibility criteria.
Methodologic quality was assessed by 2 reviewers independently using a modified version of the Downs and Black checklist. Two reviewers also used a customized form to extract studies and subjects' characteristics and the proportions of subjects with active and/or latent MTrPs in each muscle assessed.
A meta-analysis was performed when there was sufficient clinical homogeneity in at least 2 studies for the same spinal disorder. The Grading of Recommendations Assessment, Development and Evaluation approach was used to rate the body of evidence in each meta-analysis. A qualitative description of the results of single studies was provided. Low-quality evidence underpinned pooled estimates of MTrPs in the upper-body muscles of subjects with chronic neck pain. The point prevalence of MTrPs in different muscles of other disorders (eg, whiplash-associated disorders, nonspecific low back pain) was extracted from single studies with low methodologic quality and small samples. Active MTrPs were found to be present in all assessed muscles of subjects diagnosed with different spinal pain disorders. Latent MTrPs were not consistently more prevalent in subjects with a spinal disorder than in healthy controls.
The MTrPs point prevalence estimates in this review should be viewed with caution because future studies with large samples and high methodologic quality are likely to change them substantially.
Which is the most effective conservative intervention for patients with non-specific chronic neck pain (CNSNP)?
A systematic review and network meta-analysis of randomised clinical trials.
Adults ...with CNSNP of at least 3 months duration.
All available pharmacological and non-pharmacological interventions.
The primary outcomes were pain intensity and disability. The secondary outcome was adverse events.
Overall, 119 RCTs (12,496 patients; 32 interventions) were included. Risk of bias was low in 50.4% of trials, unclear in 22.7% and high in 26.9%. Compared with inert treatment, a combination of active and/or passive multimodal non-pharmacological inventions (eg, exercise and manual therapy) were effective for pain on a 0-to-10 scale at 1 month (MD range 0.84 to 3.74) and at 3 to 6 months (MD range 1.06 to 1.49), and effective on disability on a 0-to-100 scale at 1 month (MD range 10.26 to 14.09) and 3 to 6 months (MD range 5.60 to 16.46). These effects ranged from possible to definite clinical relevance. Compared with inert treatment, anti-inflammatory drugs alone or in combination with another non-pharmacological treatment did not reduce pain at 1 month or 3 to 6 months. At 12 months, no superiority was found over inert treatment on both outcomes. Most mild adverse events were experienced following acupuncture/dry needling intervention. On average, the evidence varied from low to very low certainty.
While multimodal non-pharmacological interventions may reduce pain and disability for up to 3 to 6 months of follow-up when compared with inert treatment, the evidence was very uncertain about their effects. Better quality and larger trials are needed to improve the certainty of evidence.
PROSPERO CRD42019124501
Abstract Background Central sensitization (CS) is an important feature in patients with chronic pain. The Central Sensitization Inventory (CSI) was developed with the goal of detecting the patients' ...symptoms related to CS. Objectives This study aimed at cross-culturally adapting the CSI into Italian, and at assessing its structural and construct validity in patients with different chronic pain disorders. Design Clinimetric study. Methods The Italian version of the CSI (CSI-I) was generated following forward and backward translations, expert committee review, and pilot-testing. Patients with pain for ≥3 months were eligible if diagnosed with: low back pain (LBP), temporomandibular disorder (TMD), hand osteoarthritis (HOA), fibromyalgia (FM), or rheumatoid arthritis (RA). Structural validity was assessed with exploratory factor analysis and parallel analysis based on minimum rank factor analysis; construct validity was evaluated by testing ten hypotheses on: 1) expected differences between relevant subgroups, 2) expected correlations with other instruments measuring pain intensity, physical functioning, psychological functioning, headache symptoms, and pain self-efficacy. Results 220 patients were included: 35% with LBP, 17% with TMD, 19% with HOA, 9% with FM, and 20% with RA. Factor analyses revealed that the CSI-I is a unidimensional instrument. Construct validity was satisfactory since 80% of the hypotheses were met. Conclusions The CSI-I was successfully developed and exhibited satisfactory validity in patients with chronic pain. Its reliability, responsiveness and content validity should be investigated in future studies. Until robust evidence indicates a strong relationship between CS and the CSI-I, caution should be adopted in claiming that the CSI-I measures CS.
Altered regional activation of the lumbar extensors has been previously observed in individuals with low back pain (LBP) performing high-effort and fatiguing tasks. It is currently unknown whether ...similar alterations can be observed during low-effort functional tasks. Similarly, previous studies did not investigate whether side differences in regional activation are present in individuals with LBP. Finally, there is limited evidence of whether the extent of the alteration of regional activation is associated with clinical factors. Therefore, the aim of this study was to investigate whether individuals with LBP exhibit asymmetric regional activation of the thoraco-lumbar extensor muscles during functional tasks, and if the extent of neuromuscular control alteration is associated with clinical and psychosocial outcome domains.
21 participants with and 21 without LBP performed five functional tasks (gait, sit-to-stand, forward trunk flexion, shoulder flexion and anterior pelvic tilt). The spatial distribution of activation of the thoraco-lumbar extensor muscles was assessed bilaterally using high-density electromyography. For each side, the distribution of electromyographic (EMG) amplitude was characterized in terms of intensity, location and size. Indices of asymmetry were calculated from these features and comparisons between groups and tasks were performed using ANOVA. The features that significantly differed between groups were correlated with self-reported measures of pain intensity and other outcome domains.
Indices of asymmetry did not differ between participants with and without LBP (p > 0.11). The cranio-caudal location of the activation differed between tasks (p < 0.05), but not between groups (p = 0.64). Participants with LBP showed reduced EMG amplitude during anterior pelvic tilt and loading response phase during gait (both p < 0.05). Pearson correlation revealed that greater pain intensity was associated with lower EMG amplitude for both tasks (R<-0.5, p < 0.05).
Despite clear differences between tasks, individuals with and without LBP exhibited similar distributions of EMG amplitude during low-effort functional activities, both within and between sides. However, individuals with LBP demonstrated lower activation of the thoraco-lumbar muscles during gait and anterior pelvic tilt, especially those reporting higher pain intensity. These results have implications in the development or refinement of assessment and intervention strategies focusing on motor control in patients with chronic LBP.
Abstract
Purpose
To assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcome Measurement Information System Scale v1.2 – Global Health (PROMIS-GH).
Methods
The PROMIS-GH (also ...referred to as PROMIS-10) was administered to 4370 persons from the Dutch general population. Unidimensionality (CFI ≥ 0.95; TLI ≥ 0.95; RMSEA ≤ 0.06; SRMR ≤ 0.08), local independence (residual correlations < 0.20), monotonicity (H > 0.30), model fit with the Graded Response Model (GRM,
p
< 0.001), internal consistency (alpha > 0.75), precision (total score information across the latent trait), measurement invariance (no Differential Item Functioning DIF), and cross-cultural validity (no DIF for language, Dutch vs. United States English) of its subscales, composed of four items each, Global Mental Health (GMH) and Global Physical Health (GPH), were assessed.
Results
Confirmatory factor analyses, on both subscales, revealed slight departures from unidimensionality for GMH (CFI = 0.98; TLI = 0.95, RMSEA = 0.22; SRMR = 0.04) and GPH (CFI = 0.99; TLI = 0.97; RMSEA = 0.12; SRMR = 0.03). Local independence, monotonicity, GRM model fit, internal consistency, precision and cross-cultural validity were supported. However, Global10 (emotional problems) showed misfit on the GMH subscale, while Global08 (fatigue) presented DIF for age.
Conclusion
The psychometric properties of the PROMIS-GH in the Dutch population were considered acceptable. Sufficient local independence, monotonicity, GRM fit, internal consistency, measurement invariance and cross-cultural validity were found. If future studies find similar results, structural validity of the GMH could be enhanced by improving or replacing Global10 (emotional problems).
Background and aim
Growing attention is being given to physical functioning measures to assess interventions for low back pain (LBP). The Quebec Back Pain Disability Questionnaire (QBPDS) has never ...been validated in Italian patients, and the aim of the study was culturally adapting and validating the Italian version of the QBPDS (QBPDS-I), to allow its use with Italian-speaking patients with chronic LBP.
Methods
The QBPDS-I was developed by means of forward–backward translation, a final review by an expert committee and a test of the prefinal version to evaluate its comprehensibility. The psychometric testing included structural validity by exploratory factor analysis (EFA), reliability by internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation coefficient, ICC 2.1), measurement error by calculating the minimum detectable change (MDC), construct validity by assessing hypotheses of QBPDS correlations with the Roland Morris Disability Scale (RMDQ), the Oswestry Disability Questionnaire (ODI) and a pain numerical rating scale (NRS) (Spearman’s correlations).
Results
It took one month to develop a consensus-based version of the QBPDS-I. The questionnaire was administered to 201 subjects with chronic LBP and was well accepted. EFA suggested a one-factor 20-item solution (first factor variance explained = 54.7%). Internal consistency (
α
= 0.95) and test–retest reliability (ICC = 0.90) were excellent. The MDC was 12 scale points. Construct validity was good as all of the hypotheses were met; correlations: RMDQ (
r
= 0.40), ODI (
r
= 0.48) and NRS (
r
= 0.44).
Conclusions
The QBPDS-I is unidimensional, reliable and valid in patients with chronic LBP. Its use is recommended for clinical and research purposes.
Graphic abstract
Patient-reported outcome measures (PROMs) are increasingly important in research and clinical practice and to monitoring the efficiency of health care services. The selection process of a PROM is ...fundamental to ensure that what matters to patients is captured in a valid, reliable, responsive, and feasible manner. However, selecting a fit-for-purpose PROM is not always an easy task, as many clinimetric and sociological factors can play a role. In this Viewpoint, 2 different perspectives on PROM selection are presented and debated, and a few key suggestions are provided to improve PROM development and assessment. The measurement of physical functioning in patients with low back pain (LBP) is used as a recurring example. J Orthop Sports Phys Ther 2019;49(2):39-42. doi:10.2519/jospt.2019.0602.
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