Minimally Clinically Significant Differences for Adolescents With Chronic Pain—Variability of ROC-Based Cut Points

Assessing if an individual patient has achieved clinically meaningful changes in pain intensity is a core aspect in the evaluation of pain treatments. The aim of the present study was to define minimally clinically significant differences (MCSDs) for the numerical rating scale (0–10 NRS) in adolescents with chronic pain. Data from 153 adolescents who completed an inpatient treatment were analyzed. MCSDs were defined as those cut points that yielded an optimal balance between sensitivity and specificity with regard to patients' global impression of change. The variability of the empirically defined cut points was quantified using bootstrapping. Our results show that raw changes of 1 NRS point and percent changes of 12.5% can be considered MCSDs both within the full sample and within various subsamples of patients. Applying the MCSDs developed for adults to pediatric patients yielded extremely low sensitivities; for example, only 22% of the children who described global improvement met the 50% decrease in pain criterion. Studies evaluating chronic pain treatments for adolescents should use MCSDs that are specifically developed for this group of patients. Raw changes of 1 point and 12.5% on the 0 to 10 NRS should be considered clinically meaningful. On a methodological level, we call for more systematic studies aimed at defining MCSDs that also address the variability of cut point estimates so as to foster the integration of findings.PerspectiveMany studies are aimed at empirically defining cut points for clinically relevant pain using receiver operating characteristic-based methods. For the first time, we apply these methods to children and show that even when taking into account the variability of the method, cut points specific for children are needed.     

White Matter Involvement in Chronic Musculoskeletal Pain

There is emerging evidence that chronic musculoskeletal pain is associated with anatomic and functional abnormalities in gray matter. However, little research has investigated the relationship between chronic musculoskeletal pain and white matter. In this study, we used whole-brain tract-based spatial statistics and region-of-interest analyses of diffusion tensor imaging data to demonstrate that patients with chronic musculoskeletal pain exhibit several abnormal metrics of white matter integrity compared with healthy controls. Chronic musculoskeletal pain was associated with lower fractional anisotropy in the splenium of the corpus callosum and the left cingulum adjacent to the hippocampus. Patients also had higher radial diffusivity in the splenium, right anterior and posterior limbs of the internal capsule, external capsule, superior longitudinal fasciculus, and cerebral peduncle. Patterns of axial diffusivity (AD) varied: patients exhibited lower AD in the left cingulum adjacent to the hippocampus and higher AD in the anterior limbs of the internal capsule and in the right cerebral peduncle. Several correlations between diffusion metrics and clinical variables were also significant at a P < .01 level: fractional anisotropy in the left uncinate fasciculus correlated positively with total pain experience and typical levels of pain severity. AD in the left anterior limb of the internal capsule and left uncinate fasciculus was correlated with total pain experience and typical pain level. Positive correlations were also found between AD in the right uncinate and both total pain experience and pain catastrophizing. These results demonstrate that white matter abnormalities play a role in chronic musculoskeletal pain as a cause, a predisposing factor, a consequence, or a compensatory adaptation.PerspectivePatients with chronic musculoskeletal pain exhibit altered metrics of diffusion in the brain's white matter compared with healthy volunteers, and some of these differences are directly related to symptom severity.     

Vestibulo-ocular response and balance control in children and young adults with mild-to-moderate intellectual and developmental disability: A pilot study

The vestibulo-ocular response (VOR) may not be fully developed in children with an intellectual and developmental disability (IDD). This study aimed to identify the presence of VOR deficit in children and young adults with unspecified mild-to-moderate intellectual and developmental disability and its effect on balance control. Twenty-one children and young adults with IDD ranging in age from 8 to 22 years (mean 17.5 ± 3.9 years) were included in the study. The VOR was evaluated with the Head Impulse Test and the Static and Dynamic Visual Acuity Test (S&D-VAT). Postural stability was measured in an upright standing position by the Clinical Test for Sensory Interaction in Balance (CTSIB), single leg stance (SLS) during eyes open and eyes closed, and Romberg stance under eyes open and eyes closed conditions using a force platform. Reduced vestibulo-ocular responses were found in 13 of 21 (62%) participants who were able to complete testing. In the fifth condition of the CTSIB (standing on foam with eyes closed), those without VOR deficit were able to maintain balance longer than those with VOR deficit (29 s [median 30] vs. 12 s [median 7.3], respectively; p = 0.03). The study demonstrates potential effects of VOR deficit in children and young adults with IDD and some significant differences in balance control between those with and without a VOR deficit. VOR function in children and young adults with IDD should be routinely tested to enable early detection of deficits.     

Depressive symptoms and treatment of women with urgency urinary incontinence

Introduction and hypothesis

Depression is more common in patients with urinary incontinence (UI). Drug or rehabilitation therapy have been shown to be effective in reducing urgency UI (UUI) symptoms, but whether these treatments can ameliorate the negative impact of UUI on the psychological aspects of quality of life is unclear.

Methods

A secondary analysis of an assessor-blinded randomized controlled trial was performed. The number of depressive symptoms was the primary outcome as measured by the Center for Epidemiologic Studies Depression scale (CES-D).

Results

Thirty-six (22 %) subjects had a CES-D score >16 at baseline, the cutoff for having depressive symptoms. A significant association was found between having a CES-D score >16 and lower quality of life related to UI at baseline. The mean CES-D score among those with depressive symptoms at baseline was significantly reduced throughout the study, with a mean of 23.7 at baseline, to 18.3 and 15.2 at the 3-month and 1-year follow-up (p?<?0.001), respectively. The number of participants who had depressive symptoms decreased during the study period only in the physical therapy groups, from 31 at baseline to 28 and 25, at 3 and 12 months, respectively, while there was no such change in the drug group.

Conclusions

Patients with UUI who had depressive symptoms showed significant improvement in their depressive symptoms with treatment over 1 year. This improvement occurred regardless of the type of treatment. This study emphasizes the increasingly recognized problem of undiagnosed depression among middle-aged women with UUI.     

Reduction of hip joint reaction force via medio‐lateral foot center of pressure manipulation in bilateral hip osteoarthritis patients

Loading/excessive loading of the hip joint has been linked to onset and progression of hip osteoarthritis. Footwear‐generated biomechanical manipulation in the frontal plane has been previously shown in a cohort of healthy subjects to cause a specific gait adaption when the foot center of pressure trajectory was shifted medially, which thereby significantly reduced hip joint reaction force. The objective of the present study was to validate these results in a cohort of female bilateral hip osteoarthritis patients. Sixteen patients underwent gait analysis while using a footworn biomechanical device, allowing controlled foot center of pressure manipulation, in three para‐sagittal configurations: medial, lateral, and neutral. Hip osteoarthritis patients exhibited similar results to those observed in healthy subjects in that a medial center of pressure led to an increase in inter‐maleolar distance while step width (i.e., distance between right and left foot center of pressure) remained constant. This adaptation, which we speculate subjects adopt to maintain base of support, was associated with significantly greater hip abduction, significantly decreased hip adduction moment, and significantly reduced joint reaction force compared to the neutral and lateral configurations. Recommendations for treatment of hip osteoarthritis emphasize reduction of loads on the pathological joint(s) during daily activities and especially in gait. Our results show that a medially deviated center of pressure causes a reduction in hip joint reaction force. The present study does not prove, but rather suggests, clinical significance, and further investigation is required to assess clinical implications. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:1762–1771, 2016.     

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed.PerspectiveSystematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.     

Postural control of patients with hemiparesis: force plates measurements based on the clinical sensory organization test

Standing balance of hemiparetic patients is characterized by increased sway and an asymmetrical weight bearing distribution. The objectives of the study were to determine the feasibility of using a modified clinical sensory organization test with patients following a stroke and to evaluate the contribution of visual and somatosensory input to the standing balance of hemiparetic patients during the first two months following a stroke. Thirty patients with hemiparesis underwent functional and posturographic testing one and two months following their stroke. Testing was conducted in six stance conditions differing in somatosensory and visual input. Fifteen age-matched non-impaired subjects served as the control group. Sway Index (SI) representing the displacement of the subjects' center of pressure during stance, was generally affected by time (p = 0.003), visual input (p = 0.0001), and somatosensory input (p = 0.0061), with the effect of vision significantly greater in the patient group as compared with the control group (p = 0.0006). Despite significant functional gains in the Barthel Index and functional ambulation (p = 0.01), percentage of body weight on the involved extremity (%BW) by stance condition did not change over time. Posturographic testing is useful for determining the sensory organization abilities of stroke patients with moderate impairment and indicates that these patients are dependent on visual input for postural control. The decrease in %BW borne on the affected extremity does not change over time or with the varying of sensory input.     

Effect of attention focus on acquisition and retention of postural control following ankle sprain

OBJECTIVE: To examine the effect of attentional focus instructions and dynamic balance training on ankle sprain recovery. DESIGN: Randomized controlled trial. SETTING: Outpatient physical therapy department. PARTICIPANTS: Forty volunteers (age range, 19-33y) referred to treatment within 4 months after sustaining a grade 1 or 2 ankle sprain with no concurrent impairments. Participants were randomly allocated to 1 of 2 groups differing in training instructions. INTERVENTION: Postural control training consisted of ten 20-second trials, performed on 3 consecutive days, at 2 stability levels of the Biodex Stability System (BSS). Training instructions directed the participants to either an internal or an external focus of attention. Assessments were conducted on the BSS pre- and post-training, and 48 hours after the last session (retention test). MAIN OUTCOME MEASURES: Overall stability as indicated by variance in platform displacement in all directions; anteroposterior (AP) variance of platform displacement; and mediolateral variance of platform displacement. RESULTS: Increases in overall and AP stability were observed immediately following training in both groups and were maintained at the retention test. Interaction effect indicates greater improvement in the external-focus group. CONCLUSIONS: Our results suggest that external focus of attention is advantageous for the learning of a postural control task following an ankle injury.     

Value of quantitative sensory testing in neurological and pain disorders: NeuPSIG consensus

Quantitative sensory testing (QST) is a psychophysical method used to quantify somatosensory function in response to controlled stimuli in healthy subjects and patients. Although QST shares similarities with the quantitative assessment of hearing or vision, which is extensively used in clinical practice and research, it has not gained a large acceptance among clinicians for many reasons, and in significant part because of the lack of information about standards for performing QST, its potential utility, and interpretation of results. A consensus meeting was convened by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG) to formulate recommendations for conducting QST in clinical practice and research. Research studies have confirmed the utility of QST for the assessment and monitoring of somatosensory deficits, particularly in diabetic and small fiber neuropathies; the assessment of evoked pains (mechanical and thermal allodynia or hyperalgesia); and the diagnosis of sensory neuropathies. Promising applications include the assessment of evoked pains in large-scale clinical trials and the study of conditioned pain modulation. In clinical practice, we recommend the use QST for screening for small and large fiber neuropathies; monitoring of somatosensory deficits; and monitoring of evoked pains, allodynia, and hyperalgesia. QST is not recommended as a stand-alone test for the diagnosis of neuropathic pain. For the conduct of QST in healthy subjects and in patients, we recommend use of predefined standardized stimuli and instructions, validated algorithms of testing, and reference values corrected for anatomical site, age, and gender. Interpretation of results should always take into account the clinical context, and patients with language and cognitive difficulties, anxiety, or litigation should not be considered eligible for QST. When appropriate standards, as discussed here, are applied, QST can provide important and unique information about the functional status of somatosensory system, which would be complementary to already existing clinical methods.     

Translation and validation of the Arab version of the fear avoidance beliefs questionnaire

Objective: Determine the reliability and validity of the fear avoidance beliefs questionnaire (FABQ) translated into Arabic. Methods: The FABQ work and physical activity subscales (FABQ-W and FABQ-PA) were translated and culturally adapted into Arabic using the back-translation procedure. Forty-eight subjects with acute low back pain (LBP) and 63 subjects with chronic LBP, whose native language was Arabic, completed a demographic questionnaire, the FABQ, a pain intensity numerical scale, the Modified Oswestry Disability Index (MOSW), and the SF-36 questionnaire. Thirty patients completed the FABQ a second time 3-7 days later. Results: FABQ-W and FABQ-PA showed good internal consistencies (α=0.90 and 0.81 respectively). Test-retest reliability was moderate to high (ICC (1,1) of 0.63 and 0.83 for the FABQ-W and FABQ-PA, respectively). Pain intensity correlated with FABQ-W only for subjects with acute pain (rho 0.41), and with the FABQ-PA only for subjects with chronic pain (rho 0.47). Significant differences between patients with acute and chronic pain were found. Correlations between the FABQ and the MOSW were moderate (rho between 0.40-0.42). Correlations between the FABQ subscales and the SF-36 questionnaire were stronger for subjects with chronic pain. A high ceiling effect was demonstrated for the FABQ-PA, in particular for patients with chronic LBP. Conclusions: The Arabic version of the FABQ has acceptable psychometric properties. However, the results of the physical activity subscale should be interpreted with caution due to a strong ceiling effect.