Alessandro Chiarotto

Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis.

Objective To assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain. Design Systematic review and random effects meta-analysis of randomised controlled trials. Data sources Electronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials. Study selection criteria Trials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non- multidisciplinary intervention. Results Forty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, −0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery. Conclusions Multidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care.

A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

BackgroundLow back pain (LBP) is one of the most disabling and costly disorders affecting modern society, and approximately 90% of patients are labelled as having non-specific LBP (NSLBP). Several interventions for patients with NSLBP have been assessed in clinical trials, but heterogeneous reporting of outcomes in these trials has hindered comparison of results and performance of meta-analyses. Moreover, there is a risk of selective outcome reporting bias. To address these issues, the development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. A standardized set of outcomes for LBP was proposed in 1998, however, with evolution in COS development methodology, new instruments, interventions, and understanding of measurement properties, it is appropriate to update that proposal. This protocol describes the methods used in the initial step in developing a COS for NSLBP, namely, establishing a core domain set that should be measured in all clinical trials.Methods/DesignAn International Steering Committee including researchers, clinicians, and patient representatives from four continents was formed to guide the development of this COS. The approach of initiatives like Core Outcome Measures in Effectiveness Trials (COMET) and Outcome Measures in Rheumatology (OMERACT) was followed. Participants were invited to participate in a Delphi study aimed at generating a consensus-based core domain set for NSLBP. A list of potential core domains was drafted and presented to the Delphi participants who were asked to judge which domains were core. Participant suggestions about overlap, aggregation, or addition of potential core domains were addressed during the study. The patients’ responses were isolated to assess whether there was substantial disagreement with the rest of the Delphi panel. A priori thresholds for consensus were established before each Delphi round. All participants’ responses were analysed from a quantitative and qualitative perspective to ascertain that no substantial discrepancies between the two approaches emerged.DiscussionWe present the initial step in developing a COS for NSLBP. The next step will be to determine which measurement instruments adequately cover the domains.

Myofascial Trigger Points in Patients with Whiplash‐Associated Disorders and Mechanical Neck Pain

OBJECTIVE The aim of this study was to investigate pain patterns and the distribution of myofascial trigger points (MTPs) in whiplash-associated disorders (WADs II and III) as compared with mechanical neck pain (MNP). METHODS Manual examination of suboccipital, upper trapezius, elevator scapula, temporalis, supraspinatus, infraspinatus, deltoid, and sternocleidomastoid muscles, was done to search for the presence of both active or latent MTPs in 49 WAD patients and 56 MNP patients. Local pain and referred pain from each active MTP was recorded on an anatomical map. RESULTS The mean number of active MTPs was significantly greater in the WAD group (6.71 ± 0.79) than in the MNP group (3.26 ± 0.33) (P < 0.001), but this was not found for the latent MTPs (3.95 ± 0.57 vs. 2.82 ± 0.34; P > 0.05). In the WAD group, the current pain intensity (visual analogue scale) of the patients was significantly correlated with the number of active MTPs (rs  = 0.03, P = 0.03) and the spontaneous pain area (rs  = 0.25, P = 0.07), and the number of active MTPs was significantly correlated with the spontaneous pain area (rs  = 0.3, P = 0.03). In the MNP group, significant correlation was found only between pain duration and spontaneous pain area (rs  = 0.29, P = 0.02). CONCLUSIONS Active MTPs are more prominent in WAD than MNP and related to current pain intensity and size of the spontaneous pain distribution in whiplash patients. This may underlie a lower degree of sensitization in MNP than in WAD.

Bilateral Pressure Pain Hypersensitivity over the Hand as Potential Sign of Sensitization Mechanisms in Individuals with Thumb Carpometacarpal Osteoarthritis

OBJECTIVE To investigate whether bilateral deep tissue pressure hyperalgesia exists in individuals with unilateral thumb carpometacarpal osteoarthritis (CMC OA). METHODS A total of 32 patients with CMC OA (29 females and 3 males, aged 69-90 years old) and 32 healthy matched controls (29 females and 3 males, aged 70-90 years) were recruited. Pressure pain thresholds (PPTs) were bilaterally assessed over the first CMC joint, the hamate bone and the lateral epicondyle in a blinded design. Mixed models analyses of variance were conducted to determine the differences in pressure pain sensitivity between groups and sides. RESULTS The results showed that PPTs were significantly decreased over the first CMC joint (F = 6.551, P = 0.012) and the hamate bone (F = 9.783, P = 0.002) but not over the lateral epicondyle (F = 2.712, P = 0.102) in patients with thumb CMC OA as compared with healthy controls; patients with unilateral thumb CMC OA exhibited bilateral pressure pain hyperalgesia in both hands compared with healthy people. PPTs were not significantly associated to the intensity of pain (all, P > 0.05). DISCUSSION This study revealed bilateral localized pressure pain hypersensitivity over the hand in individuals with unilateral thumb CMC OA, suggesting spinal cord sensitization mechanisms in this population. Future studies should analyze the presence of widespread pressure pain sensitivity in patients with thumb CMC OA to further determine the presence of central sensitization mechanisms.

Effects of Passive Upper Extremity Joint Mobilization on Pain Sensitivity and Function in Participants With Secondary Carpometacarpal Osteoarthritis: A Case Series

OBJECTIVE The purpose of this case series is to report on the effects of passive joint mobilization (PJM) of the shoulder, elbow, and wrist on pain intensity, pain sensitivity, and function in elderly participants with secondary carpometacarpal osteoarthritis (CMC OA). METHODS Fifteen inpatients from the Department of Physical Therapy, Residenze Sanitarie Assistenziali, Collegno (Italy), with secondary CMC OA (70-90 years old) were included in this study. All patients received PJM of the dominant arm (shoulder, elbow, and wrist) for 4 sessions for 2 weeks. Pain severity was measured by visual analog scale, and pain sensitivity was measured with pressure pain threshold (PPT) at CMC joint, at the tubercle of the scaphoid bone, and at the unciform apophysis of the hamate bone. Tip and tripod pinch strength were measured by a pinch gauge. RESULTS Passive joint mobilization reduced pain severity after the first follow-up by 30%, in addition to increased PPT by 13% in the hamate bone. Strength was enhanced after treatment. Tripod pinch increased by 18% in the dominant hand after treatment. CONCLUSIONS This case series provides preliminary evidence that PJM of upper extremity joints diminished pain and may increase PPT tip and tripod pinch in some participants with secondary CMC OA.

Widespread pressure pain hypersensitivity in elderly subjects with unilateral thumb carpometacarpal osteoarthritis.

BackgroundWidespread pressure hypersensitivity is one of the signs that characterize central pain sensitization in subjects with knee and hip osteoarthritis (OA). The purpose of this study was to evaluate whether widespread pressure pain hyperalgesia is a feature of individuals with unilateral symptomatic thumb carpometacarpal (CMC) OA.MethodsA total of 16 patients with unilateral symptomatic thumb CMC OA and 16 healthy sex- and age-matched controls were recruited. Pressure pain thresholds (PPTs) were assessed bilaterally over the first CMC joint; the C5–C6 zygapophyseal joint; the median, ulnar, and radial nerves; and tibialis anterior muscle. Grip and key strength, intensity of pain, and function QuickDASH were also measured.ResultsThe analyses showed that patients with thumb CMC OA present bilaterally decreased PPTs over the first CMC joint, the C5–C6 zygapophyseal joint, and the tibialis anterior, median, ulnar and radial nerve as compared to controls (all, P < 0.01). Patients with thumb CMC OA also exhibited a bilateral reduction in pinch and grip strength than controls (P < 0.05). A significant correlation was found between PPT over the radial nerve and QuickDASH (r = 0.546, P = 0.029).ConclusionThis study revealed bilateral widespread pressure pain hypersensitivity in individuals with unilateral symptomatic thumb CMC OA, suggesting that central pain processing mechanisms might be a feature of this pain population. These results should be taken into consideration when addressing future treatment approaches.

COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study

BackgroundContent validity is the most important measurement property of a patient-reported outcome measure (PROM) and the most challenging to assess. Our aims were to: (1) develop standards for evaluating the quality of PROM development; (2) update the original COSMIN standards for assessing the quality of content validity studies of PROMs; (3) develop criteria for what constitutes good content validity of PROMs, and (4) develop a rating system for summarizing the evidence on a PROM’s content validity and grading the quality of the evidence in systematic reviews of PROMs.MethodsAn online 4-round Delphi study was performed among 159 experts from 21 countries. Panelists rated the degree to which they (dis)agreed to proposed standards, criteria, and rating issues on 5-point rating scales (‘strongly disagree’ to ‘strongly agree’), and provided arguments for their ratings.ResultsDiscussion focused on sample size requirements, recording and field notes, transcribing cognitive interviews, and data coding. After four rounds, the required 67% consensus was reached on all standards, criteria, and rating issues. After pilot-testing, the steering committee made some final changes. Ten criteria for good content validity were defined regarding item relevance, appropriateness of response options and recall period, comprehensiveness, and comprehensibility of the PROM.DiscussionThe consensus-based COSMIN methodology for content validity is more detailed, standardized, and transparent than earlier published guidelines, including the previous COSMIN standards. This methodology can contribute to the selection and use of high-quality PROMs in research and clinical practice.

Dimensionality and Reliability of the Central Sensitization Inventory in a Pooled Multicountry Sample

Central sensitization (CS) involves the amplification of neural signaling within the central nervous system, which evokes pain hypersensitivity. The Central Sensitization Inventory (CSI) assesses 25 overlapping health-related symptom dimensions that have been reported to be associated with CS-related disorders. Previous studies have reported satisfactory test-retest reliability and internal consistency, but factor analyses have exhibited conflicting results in different language versions. The purpose of this cross-sectional study was to thoroughly examine the dimensionality and reliability of the CSI, with pooled data from 1,987 individuals, collected in several countries. The principal component analysis suggested that 1 general factor of CS best described the structure. A subsequent confirmatory factor analysis revealed that a bifactor model, which accounted for the covariance among CSI items, with regard to 1 general factor and 4 orthogonal factors, fit the CSI structure better than the unidimensional and the 4-factor models. Additional analyses indicated substantial reliability for the general factor (ie, Cronbach α = .92; ω = .95; and ω hierarchical = .89). Reliability results for the 4 specific factors were considered too low to be used for subscales. The results of this study clearly suggest that only total CSI scores should be used and reported. PERSPECTIVE As far as we know, this is the first study that has examined the factor structure and reliability of the CSI in a large multicountry sample. The CSI is currently considered the leading self-report measure of CS-related symptoms worldwide.

Core outcome measurement instruments for clinical trials in non-specific low back pain

Abstract 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.

Botulinum toxin type A combined with neurodynamic mobilization for upper limb spasticity after stroke: a case report

OBJECTIVE The purpose of this study is to report a case in which combinatory therapy of botulinum toxin type A (BoNT-A) and neurodynamic mobilization (NM) was used as treatment for a patient with severe upper limb spasticity and pain after stroke. CLINICAL FEATURES A 76-year-old male patient had spastic muscles in the upper limb 10 months after an ischemic stroke. INTERVENTION AND OUTCOME The patient underwent combined treatment with BoNT-A and NM of the upper limb in 6 monthly applications. Evaluation was performed pretreatment, 3 months after the first injection, 3 months after the second injection, and at a follow-up session 9 months after starting the treatment. The following outcomes were measured: pain by using a numeric rating scale, spasticity by the Modified Ashworth Scale for Grading Spasticity, acceptance and emotional reaction to the treatment by the Hospital Anxiety and Depression Scale, and functionality by ranges of motion. The patient improved in all outcomes after treatment, and results were maintained during the follow-up sessions. CONCLUSION The combined NM and BoNT-A treatment appeared to decrease pain and improve joint ranges of motion during treatment for this patient. The patient showed decreased anxiety and depression during and after the treatment.