Pain Intensity Numerical Rating Scale Research Articles

Clinical usefulness of intermediate-dose dexmedetomidine (0.75 μg/kg) in flexible bronchoscopy - A prospective, randomized, double-blinded study.

BACKGROUND:Dexmedetomidine, although an effective drug for conscious sedation during flexible bronchoscopy, has occasional side effects on the cardiovascular system which need to be addressed.MATERIALS AND METHODS:Patients between 18 and 65 years, requiring diagnostic flexible bronchoscopy, found eligible, after screening, were randomized to either receive 0.75 μg/kg intravenous dexmedetomidine over 10 min or intravenous midazolam 0.035 mg/kg over 1 min. Composite score was used as the primary outcome measure. Additional parameters recorded were: Hemodynamic variables, oxygen saturation, Ramsay sedation score, for pain intensity and distress Numerical Rating Scale, number of rescue medication doses, ease of doing bronchoscopy, Visual Analog Scale score for cough and response of the patient 24 h after bronchoscopy.RESULTS:In each group, 24 patients were enrolled. The composite score was in the ideal category in 24 patients in dexmedetomidine group and 21 in midazolam group, at nasopharynx (P = 0.234). The corresponding values at the level of trachea were 23 and 16 (P = 0.023). In dexmedetomidine group, patient response after 24 h of bronchoscopy showed quality of sedation to be excellent in 0 subjects, good in 13, fair in 9 and poor in 2 and discomfort to be nil in 7, mild 10, moderate in 7 and severe in 0. The corresponding values in midazolam group for quality of sedation were 0, 4, 14, 6, and for discomfort 0, 10, 14, 0. The Visual Analog Scale (VAS) for cough revealed a mean score of 0.800 and 1.812 (P = 0.011) during and 2.092 and 3.542 (P = 0.016) 24 h after bronchoscopy in the respective study groups.CONCLUSION:Low-dose dexmedetomidine (0.75 μg/kg single dose) appears to provide better patient comfort and equivalent safety profile when compared with midazolam.

Editors' Note: Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy

In “Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy,” Geerts et al. report no significant difference in Pain Intensity Numerical Rating Scale score for patients with idiopathic small fiber neuropathy (I-SFN) 12 weeks after randomized administration of IVIG or placebo. In “Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy,” Geerts et al. report no significant difference in Pain Intensity Numerical Rating Scale score for patients with idiopathic small fiber neuropathy (I-SFN) 12 weeks after randomized administration of IVIG or placebo.

BrightHearts: A pilot study of biofeedback assisted relaxation training for the management of chronic pain in children with cerebral palsy.

BackgroundChronic pain is estimated to impact one‐in‐three children with cerebral palsy (CP). Psychological interventions including behavioral and cognitive strategies play a key role in chronic pain management, but there is a paucity of research exploring their use in children with CP.AimTo investigate the acceptability and feasibility of biofeedback assisted relaxation training (BART) for chronic pain management in children with CP using a mixed‐methods study design.MethodsBiofeedback assisted relaxation training was delivered via BrightHearts, an iOS application. Inclusion criteria were as follows: CP; self‐reported chronic pain; age 9‐18 years; and fluent English speaker. Children used BrightHearts for ten minutes daily, over four weeks. Qualitative post‐intervention interviews were undertaken (child, parent) and quantitative pre‐post measures (child) were gathered including pain intensity (numerical rating scale), and anxiety intensity (numerical rating scale). Content analysis was conducted for qualitative data. Descriptive statistics and exploratory analyses were performed for quantitative data.ResultsTen children participated (n = 3 male, mean age = 13.1 years SD = 2.5 years, GMFCS level I = 4, II = 2, III = 3, IV = 1). Predominant movement disorder was spasticity (n = 7) and dyskinesia, mainly dystonia (n = 3). Content analysis suggested an overarching theme “BrightHearts is a good thing to put in my toolbox” providing an overall representation of participants’ experiences. For many, BrightHearts was a valuable supplement to children's pain management strategies: “The source of the pain is still there, but the actual effect of the pain isn't so relevant.” Four sub‐themes were identified: “Managing my pain;” “Managing my anxiety and stress,” “Helping me do what I need to do;” and “Fitting it into my life.” Some participants reported improvements in their anxiety management, and others described benefits in sleep and school following improved pain/anxiety management. A range of practical and personal factors within this heterogeneous group presented barriers to using BrightHearts including limited time, attention, and boredom. Seven‐out‐of‐eight children would recommend BrightHearts to others with chronic pain and six‐out‐of‐eight noticed a difference in their pain since using BrightHearts (n = 2 missing data). Non‐significant reductions in pain or anxiety intensity scores were found following the intervention.ConclusionThis pilot suggests BrightHearts is an acceptable and feasible intervention for chronic pain management in children with CP and may be useful for some children as part of a multimodal approach.

Effect of Briefing on Acupuncture Treatment Outcome Expectations, Pain, and Adverse Side Effects Among Patients With Chronic Low Back Pain

In observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations. To investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP). This randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018. Patients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course. The primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects. A total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant. In this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses. German Clinical Trials Register Identifier: DRKS00010191.

Pain Assessment during Gnathological Treatment of Temporomandibular Myofascial Pain through Mandibular Repositioning Splints Designed after a Posture-Stabilometric Evaluation

The aim of the study is to evaluate the effectiveness of two complementary mandibular repositioning splints (SVED and MORA) designed after a preliminary patients’ posture-stabilometric evaluation in treatment for temporomandibular myofascial pain (TMP) using the Pain-Intensity Numeric Rating Scale (PI-NRS) assessment. Eighty-six consecutive sportive non-agonistic subjects with TMP were randomly divided in two groups. Forty-two wear mandibular repositioning splints designed by a posture-stabilometric evaluation, thus constituting the test group. The other 44 subjects were not subjected to any treatment, thus represented the control group. To record pain intensity, subjects in both groups were asked to fill in a PI-NRS which ranged from 0 (no pain) to 10 (worst imaginable pain). In the test group, PI-NRS was assessed three times: before starting therapy (t0), after 4 months (t1) and after 8 months (t2) of treatment. Instead, in the control group PI-NRS was recorded during the first visit (t0) and after 8 months (t2). The Friedman test showed a statistically significant decrease in PI-NRS mean scores after 4 (t1) and 8 (t2) months from the start of the gnathological therapy with mandibular repositioning splints, (p < 0.001) in test group. There is enough evidence to assess that occlusal splint therapy for mandibular repositioning (MORA and SVED) designed through a posture-stabilometric evaluation could be considered in the treatment of temporomandibular myofascial pain.

Randomized, double-blind, placebo-controlled trial of ISC 17536, an oral inhibitor of transient receptor potential ankyrin 1, in patients with painful diabetic peripheral neuropathy: impact of preserved small nerve fiber function.

Patients with chronic pain syndromes, such as those with painful peripheral neuropathy due to diabetes mellitus, have limited treatment options and suffer ongoing attrition of their quality of life. Safer and more effective treatment options are needed. One therapeutic approach encompasses phenotypic characterization of the neuropathic pain subtype, combined with the selection of agents that act on relevant mechanisms. ISC 17536 is a novel, orally available inhibitor of the widely expressed pain receptor, transient receptor potential ankyrin 1, which mediates nociceptive signaling in peripheral small nerve fibers. In this randomized, placebo-controlled, proof-of-concept trial, we assessed the safety and efficacy of 28-day administration of ISC 17536 in 138 patients with chronic, painful diabetic peripheral neuropathy and used quantitative sensory testing to characterize the baseline phenotype of patients. The primary end point was the change from baseline to end of treatment in the mean 24-hour average pain intensity score based on an 11-point pain intensity numeric rating scale. The study did not meet the primary end point in the overall patient population. However, statistically significant and clinically meaningful improvement in pain were seen with ISC 17536 in an exploratory hypothesis-generating subpopulation of patients with preserved small nerve fiber function defined by quantitative sensory testing. These results may provide a mechanistic basis for targeted therapy in specific pain phenotypes in line with current approaches of "precision medicine" or personalized pain therapeutics. The hypothesis is planned to be tested in a larger phase 2 study.

Mindfulness-based therapy compared to cognitive behavioral therapy for opioid-treated chronic low back pain: Protocol for a pragmatic randomized controlled trial

ObjectiveChronic low back pain (CLBP) is disabling and costly. Existing therapies have proven suboptimal, with many patients resorting to long-term opioid therapy, which can cause harms. Cognitive behavioral (CBT) and mindfulness-based (MBT) therapies can be effective and offer unique skills for safe pain coping. This article describes the protocol for a study evaluating comparative effectiveness of CBT and MBT in adults with opioid-treated CLBP. DesignPragmatic, multi-center randomized controlled trial (RCT). SettingsCommunity and outpatient care. ParticipantsPlanned enrollment of 766 adults (383/group) with CLBP treated with long-term opioids (≥3 months; ≥15 mg/day morphine-equivalent dose). InterventionsCBT or MBT consisting of eight weekly therapist-led, two-hour group sessions, and home practice (≥30 min/day, 6 days/week) during the 12-month study. Main outcome measuresMain outcome measures, collected by self-report at baseline, then three, six, nine and 12 months post-entry, include co-primary measures: pain intensity (Numeric Rating Scale) and function (Oswestry Disability Index), and secondary measures: quality of life (Medical Outcomes Study) and average daily opioid dose (Timeline Followback). Baseline scores of depression, anxiety, and opioid misuse questionnaires will be assessed as potential contributors to the heterogeneity of treatment response. Intention-to-treat, linear mixed-effects analysis will examine treatment effectiveness. Qualitative data will augment the quantitative measures. ConclusionsThis will be the largest RCT comparing CBT and MBT in opioid-treated CLBP. It will provide evidence on the impact of these interventions, informing clinical decisions about optimal therapy for safe, effective care, improving quality of life and decreasing opioid-related harm among adults with refractory CLBP.

Patient-centered care or osteopathic manipulative treatment as mediators of clinical outcomes in patients with chronic low back pain.

Patient-centered care is often considered a characteristic of osteopathic medicine, in addition to the use of osteopathic manipulative treatment (OMT) in such musculoskeletal conditions as low back pain. This study aimed to determine if patient-centered care or OMT are mediators of the clinical outcomes of osteopathic medicine in patients with chronic low back pain. A comparative effectiveness study was conducted within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION Pain Research Registry). Eligible patients met the diagnostic criteria recommended by the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain and completed four consecutive quarterly encounters between April 2016 and November 2020. The Consultation and Relational Empathy instrument for patient-centered care was used at the baseline encounter and OMT use was measured at the final encounter. The clinical outcome measures included low back pain intensity on a numerical rating scale (NRS) from 0 to 10, back-related functioning on the Roland-Morris Disability Questionnaire (RMDQ), and pain impact on the National Institutes of Health Minimum Dataset for Chronic Low Back Pain (NIH-MDS). A parallel multiple mediator model was used to compute the direct and indirect effects of osteopathic medicine in achieving each of the three clinical outcomes. The 404 study patients had a mean age of 52.2 years (standard deviation, 13.1 years) and 288 (71.3%) were female. The 88 (21.8%) patients treated by osteopathic physicians reported more favorable scores for patient-centered care (mean, 41.3; 95% CI 39.0-43.5) than patients treated by allopathic physicians (mean, 38.0; 95% CI 36.8-39.3) (p=0.02). Fifty-six (63.6%) patients treated by osteopathic physicians used OMT. The age- and sex-adjusted outcomes for patients of osteopathic vs. allopathic physicians across all four encounters were: mean, 5.4; 95% CI 5.0-5.7 vs. mean, 5.9; 95% CI 5.7-6.1 on the NRS for pain intensity (p=0.01); mean, 11.3; 95% CI 10.1-12.6 vs. mean, 14.0; 95% CI 13.3-14.7 on the RMDQ for back-related disability (p<0.001); and mean, 26.8; 95% CI 24.9-28.7 vs. mean, 30.1; 95% CI 29.1-31.1 on the NIH-MDS for pain impact (p=0.002). Patient-centered care did not mediate any outcome of osteopathic medicine, whereas OMT mediated better outcomes in low back pain intensity. This appears to be the first study to simultaneously address both patient-centered care and OMT as potential mediators of the effect of osteopathic medicine in treating chronic pain. Patient-centered care did not mediate the effects of osteopathic medicine and OMT only mediated outcomes relating to low back pain intensity. More research is needed to identify other aspects of osteopathic medicine that mediate its beneficial effects in patients with chronic low back pain.

Correlational analysis of chemokine and inflammatory cytokine expression in the intervertebral disc and blood in patients with lumbar disc disease.

The involvement of intervertebral disc (IVD) tissues, whole blood (WB) cytokines, and chemokines in pain in patients with lumbar degenerative disc disease (LDD) is unknown. We investigated the relationships between inflammatory cytokines and chemokines in human IVD tissues and WB samples and their association with pain. Expression levels of chemokines and cytokine gene expression were measured in samples from 20 patients with LDD and compared between IVD tissues and WB samples. The associations between WB chemokine and cytokine gene expression levels and pain intensity (numeric rating scale) were also analyzed. The mRNA of C-C chemokine ligand 20 (CCL20), C-C chemokine receptor 6 (CCR6), interleukin-6 (IL-6), IL-1β, IL-17, and tumor necrosis factor-α (TNF-α) was expressed in degenerated IVD tissues. Pearson's product-moment correlation analysis produced positive correlations between CCR6 and IL-6 expression levels in IVD tissues (r = 0.845, p < 0.001) and WB samples (r = 0.963, p < 0.001). WB IL-6 and CCR6 mRNA expression levels correlated significantly with present pain, maximum pain, and average pain. By contrast, low back pain (LBP) did not correlate with serum chemokine/cytokine expression. This is the first study to report correlations between chemokine and inflammatory cytokine gene expression levels in IVD tissues and WB samples in patients with LDD in relation to pain intensity. WB CCR6 and IL-6 gene expression levels correlated significantly with present pain, maximum pain, and average pain, but not with LBP. These data provide a new understanding of the role of chemokines and inflammatory cytokines in patients with LDD and may lead to new treatment strategies for pain.

Does Social Support Moderate Wound Pain and Health-Related Quality of Life in Patients With Chronic Wounds? A Multicenter Descriptive Cross-sectional Study.

We sought to explore the relationships among social support, health-related quality of life (HRQOL), and wound pain, and to examine whether social support would moderate the relationship between wound pain and HRQOL. A multicenter descriptive cross-sectional study. Individuals with chronic wounds attending wound clinics affiliated with 3 public hospitals in Beijing, China. Sociodemographic and wound characteristics of 162 participants were retrieved from medical records. Participants completed questionnaires for wound-related pain intensity (Numerical Rating Scale), social support (Social Support Rating Scale), and HRQOL (Medical Outcome Study Short Form-36). The moderating effect analysis was examined using the PROCESS analytic tool developed by Hayes, based on the bias-corrected bootstrapping method. Results revealed that higher pain intensity was significantly related to lower HRQOL (P < .01), and higher social support was associated with better HRQOL (P < .01). However, there was no significant correlation between social support and wound pain (P = .55). Importantly, the moderating effect of social support on the relationship between wound pain and HRQOL was statistically significant (P = .008). We found that social support moderated the impact of wound pain on HRQOL in patients with chronic wounds. This finding suggests that support obtained from social networks may be a beneficial intervention to improve the HRQOL of patients with chronic wounds, especially those suffering from high-intensity wound pain.

Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 μs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

Cryoneurolysis\u2019 outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial

BackgroundLow-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome.Methods A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients’ impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory).Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6).DiscussionThis study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.Trial registrationThe trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145.

Cross-cultural adaptation, reliability and validity of the Fremantle Knee Awareness Questionnaire in Italian subjects with painful knee osteoarthritis

Background and aimGrowing attention is being given to utilising physical function measures to better understand and manage knee osteoarthritis (OA). The Fremantle Knee Awareness Questionnaire (FreKAQ), a self-reported measure of body-perception specific to the knee, has never been validated in Italian patients. The aims of this study were to culturally adapt and validate the Italian version of the FreKAQ (FreKAQ-I), to allow for its use with Italian-speaking patients with painful knee OA.MethodsThe FreKAQ-I was developed by means of forward–backward translation, a final review by an expert committee and a test of the pre-final version to evaluate its comprehensibility. The psychometric testing included: internal structural validity by Rasch analysis; construct validity by assessing hypotheses of FreKAQ correlations with the knee injury and osteoarthritis outcome score (KOOS), a pain intensity numerical rating scale (PI-NRS), the pain catastrophising scale (PCS), and the Hospital anxiety and depression score (HADS) (Pearson’s correlations); known-group validity by evaluating the ability of FreKAQ scores to discriminate between two groups of participants with different clinical profiles (Mann–Whitney U test); reliability by internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation coefficient, ICC2.1); and measurement error by calculating the minimum detectable change (MDC).ResultsIt took one month to develop a consensus-based version of the FreKAQ-I. The questionnaire was administered to 102 subjects with painful knee OA and was well accepted. Internal structural validity confirmed the substantial unidimensionality of the FreKAQ-I: variance explained was 53.3%, the unexplained variance in the first contrast showed an eigenvalue of 1.8, and no local dependence was detected. Construct validity was good as all of the hypotheses were met; correlations: KOOS (rho = 0.38–0.51), PI-NRS (rho = 0.35–0.37), PCS (rho = 0.47) and HADS (Anxiety rho = 0.36; Depression rho = 0.43). Regarding known-groups validity, FreKAQ scores were significantly different between groups of participants demonstrating high and low levels of pain intensity, pain catastrophising, anxiety, depression and the four KOOS subscales (p ≤ 0.004). Internal consistency was acceptable (α = 0.74) and test–retest reliability was excellent (ICC = 0.92, CI 0.87–0.94). The MDC95 was 5.22 scale points.ConclusionThe FreKAQ-I is unidimensional, reliable and valid in Italian patients with painful knee OA. Its use is recommended for clinical and research purposes.

The Relationship of Kinesiophobia with Pain and Quality of Life in Idiopathic Scoliosis.

Prospective, multi-centric, cross-sectional study. To analyze the construct validity of the Tampa Scale of Kinesiophobia (TSK) in a cohort of patients with adolescent idiopathic scoliosis (AIS). Back pain is not uncommon in AIS. The fear of movement (kinesiophobia) in response to pain is related to back pain. TSK psychometric properties in AIS patients have not been properly analyzed. Patients with AIS and no prior spine surgery were prospectively included. They fulfilled the Spanish version of the TSK-11 questionnaire, a pain intensity numerical rating scale (NRS), refined SRS-22 (SRS-22r), the Hospital Anxiety and Depression Scale (HADS), and item 7 of the Core Outcome Measurement Index (COMI). The sample was split into two groups for the statistical analysis: adolescents and young adults. Cronbach alpha was used to assess internal consistency. Discriminant and concurrent validity were obtained by computing Pearson correlation coefficients between the TSK score and several criterion measures. A total of 275 patients were included-198 adolescents (mean age of 14.6 yrs) and 77 young adults (mean age of 26.9 yrs). The Cobb of largest curve means were 44.9° and 48.9°, respectively. In the adolescent group, the TSK mean (±SD) was 21.5 (±5.93), with a floor effect of 2.5%. In the adult group, the TSK mean was 24.2 (±6.63), with a floor effect of 3.9%. The ceiling effect was 0% in both groups. Cronbach alphas for the adolescent and adult groups were 0.76 and 0.79, respectively. No correlation was found in any group between the TSK score and the curve magnitude or pattern (Lenke classification). The TSK was significantly correlated with HAD depression and SRS-22r in both groups. However, these correlations were weaker in adolescents. In adults, the TSK also significantly correlates with NRS and work/school absenteeism. The Spanish version of TSK-11 is a reliable and valid instrument to analyze kinesiophobia in AIS. However, the weak correlation between kinesiophobia and pain intensity, disability, and emotional condition in adolescents requires further study.Level of Evidence: 4.

Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy.

ObjectiveThis is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN).MethodsBetween July 2016 and November 2018, 60 Dutch patients with skin biopsy–proven I-SFN randomly received a starting dose of IVIG (2 g/kg body weight) or matching placebo (0.9% saline). Subsequently, 3 additional infusions of IVIG (1 g/kg) or placebo were administered at 3-week intervals. The primary outcome was a 1-point change in Pain Intensity Numerical Rating Scale score at 12 weeks compared to baseline.ResultsThirty patients received IVIG, and 30 received placebo. In both groups, 29 patients completed the trial. In 40% of patients receiving IVIG, the mean average pain was decreased by at least 1 point compared to 30% of the patients receiving placebo (p = 0.588, odds ratio 1.56, 95% confidence interval 0.53–4.53). No significant differences were found on any of the other prespecified outcomes, including general well-being, autonomic symptoms, and overall functioning and disability.ConclusionsThis randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN.Trial Registration InformationClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31.Classification of EvidenceThis study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.

Alpha entrainment drives pain relief using visual stimulation in a sample of chronic pain patients: a proof-of-concept controlled study.

One-third of the population in the UK and worldwide struggle with chronic pain. Entraining brain alpha activity through noninvasive visual stimulation has been shown to reduce experimental pain in healthy volunteers. Neural oscillations entrainment offers a potential noninvasive and nonpharmacological intervention for patients with chronic pain, which can be delivered in the home setting and has the potential to reduce use of medications. However, evidence supporting its use in patients with chronic pain is lacking. This study explores whether (a) alpha entrainment increase alpha power in patients and (b) whether this increase in alpha correlates with analgesia. In total, 28 patients with chronic pain sat in a comfortable position and underwent 4-min visual stimulation using customised goggles at 10 Hz (alpha) and 7 Hz (control) frequency blocks in a randomised cross-over design. 64-channel electroencephalography and 11-point numeric rating scale pain intensity and pain unpleasantness scores were recorded before and after stimulation. Electroencephalography analysis revealed frontal alpha power was significantly higher when stimulating at 10 Hz when compared to 7 Hz. There was a significant positive correlation between increased frontal alpha and reduction in pain intensity (r = 0.33; P < 0.05) and pain unpleasantness (r = 0.40; P < 0.05) in the 10 Hz block. This study provides the first proof of concept that changes in alpha power resulting from entrainment correlate with an analgesic response in patients with chronic pain. Further studies are warranted to investigate dose-response parameters and equivalence to analgesia provided by medications.

Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

BackgroundGeneral physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF.MethodsBy means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05).ResultsTime, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up.ConclusionsA rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months.Trial registrationOn 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Retrolaminar Block Versus Paravertebral Block for Pain Relief After Less-Invasive Lung Surgery: A Randomized, Non-Inferiority Controlled Trial.

IntroductionA retrolaminar block (RLB) is a modified paravertebral technique with a local anesthetic injected at the retrolaminar site. The aim of this non-inferiority, parallel-group, prospective, and randomized study was to compare the analgesic efficacy of the paravertebral block (PVB) and RLB after lung surgery.MethodsEligible subjects were patients aged more than 20 years, with American Society of Anesthesiologists physical status Ⅰ or II, who were scheduled to undergo video-assisted thoracoscopic surgery (VATS) or limited thoracotomy because of lung disease. Patients were randomly allocated to receive either a PVB or RLB using a computer-generated sequence and sealed opaque envelopes. The PVB and RLB were induced by injecting 20 mL of 0.50% ropivacaine and 40 mL 0.25% ropivacaine, respectively. As the primary outcome variable, we considered the area under the curve (AUC) of the postoperative pain intensity using the trapezoidal method. Pain intensity was assessed using an 11-point numerical rating scale (NRS). We converted the NRS (0-10) into the visual analog scale (VAS) (0-100 mm) proportionally. We compared the AUC of the converted NRS (AUC-cNRS) on coughing between one and two hours after the operation. The non-inferiority margin was set at 25 mm × h in the AUC-cNRS. Patients and nurses were blinded to group assignments. Secondary outcomes included time to perform the block, NRS for pain intensity at rest and on coughing at one, two, four, 24, and 48 hours after the operation, the incidence of postoperative nausea and vomiting, time to first morphine use after the operation, and cumulative morphine consumption at 24 and 48 hours after the operation.ResultsIn each group, 25 patients were randomized and analyzed. No significant difference in the AUC-cNRS was noted between the groups (P = 0.117). The mean difference in the AUC-cNRS (group RLB minus group PVB) was 13.42 mm × h, 95% confidence interval, −3.48 to 30.32 mm × h. However, when patients with unexpectedly extended skin incision were excluded from the analysis, the AUC-cNRS of group RLB was significantly higher as compared to group PVB (P = 0.0388). The time to perform the block was longer in PVB as compared to the RLB group (P < 0.0001). No significant differences were noted in the remaining secondary outcomes.ConclusionThe non-inferiority of RLB as compared to PVB was not confirmed. Though RLB has the advantage of a shorter time to perform, RLB is not recommended for patients undergoing VATS or limited thoracotomy because of lack of efficacy as compared to PVB.

Relationships among lumbar hip motion angle, perceptual awareness, and low back pain in young adults.

[Purpose] We aimed to examine the relationships among low back pain, lumbar-hip motion angle, and lumbar perceptual awareness in young adults to improve the treatment of low back pain. [Participants and Methods] Data were collected from 36 university students with low back pain. The items included for evaluation were the low back pain intensity (Numeric Rating Scale), disability due to low back pain (Oswestry Low Back Pain Disability Index), lumbar spine and hip motion angles in test movements, and perceptual awareness (Fremantle Back Awareness Questionnaire). The test movements employed included trunk forward bending, trunk back bending, and prone hip extension. The motion angles of the lumbar spine and hip joints were measured using a wearable sensor. [Results] The Numeric Rating Scale was not correlated with the lumbar hip motion angle and perceptual awareness. The Oswestry Low Back Pain Disability Index was correlated with lumbar hip motion angles, at the beginning of trunk forward bending and at maximum trunk backward bending, and with perceptual awareness. [Conclusion] There are relationships among disabilities due to low back pain, lumbar hip motion angles, and perceptual awareness in each test movement; however, they vary depending on the type and angle of the test movement conducted.

Effectiveness of transcranial direct current stimulation on pain and function in knee osteoarthritis: a systematic review with meta-analysis based on PRISMA guidelines

IntroductionTo evaluate the effectiveness of transcranial direct current stimulation (tDCS) on pain and quality of life in patients with knee osteoarthritis (OA).MethodsThe meta-analysis data source were PubMed (MEDLINE) and Cochrane (Central). Randomized controlled trials comparing active tDCS (in combination with other interventions or alone in knee OA patients) with sham tDCS published in English till July 2019 were analysed. The outcome measures were pain intensity (visual analogue scale and numeric rating scale) and quality of life (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]). Mean difference with 95% confidence interval for the active tDCS and sham groups were investigated.ResultsFour articles with 171 patients were included in the qualitative systematic review and 2 articles with 55 patients were included in the quantitative meta-analysis. The results revealed a statistically significant reduction in pain (visual analogue scale) in the active tDCS group compared with the sham group (&lt;i&gt;Z&lt;/i&gt; = 7.32, &lt;i&gt;p&lt;/i&gt; &lt; 0.00001) and a significant improvement in WOMAC scores (&lt;i&gt;Z&lt;/i&gt; = 2.31, &lt;i&gt;p&lt;/i&gt; = 0.02), with high heterogeneity of 83%.ConclusionsThere is a significant improvement in pain and function in patients with knee OA after the application of active tDCS either alone or in combination. However, more studies are required to confirm the effectiveness of tDCS in knee OA. Owing to the promising results of tDCS in various pain conditions and in knee OA, it can be seen as a future tool for managing pain in the field of physiotherapy.