Validación de test de flexión-relajación para definir un déficit lumbar con electrodos tetrapolares / Validation of the flexion-relaxation test to define a lumbar deficit with tetrapolar electrodes

Introducción y objetivo: Obtener un nuevo punto de corte (PC) para un test de flexión-relajación (FR) lumbar efectuado con electrodos (e.) tetrapolares, desde valores ya definidos con dispositivos bipolares.Materiales y métodosLa muestra del estudio consta de 47 pacientes en situación de incapacidad temporal por dolor lumbar (DL). Fueron evaluados mediante un test de dinamometría isométrica, una prueba cinemática y una valoración del fenómeno FR.Se plantean dos experimentos con curvas ROC. El primero, con 47 pacientes que efectuaron de modo consecutivo el test FR con ambos tipos de electrodos, utilizándose como variable de clasificación el punto de corte conocido para los e. bipolares (2,49uV). En el segundo, con los datos de la EMGs registrados con e. tetrapolares en 17 pacientes, se efectúa un test de DeLong que compara las 2 curvas ROC que construimos, por un lado, al clasificar la muestra desde pruebas de dinamometría y cinemática, y por el otro, al clasificarlos con los valores de la EMGs bipolar.ResultadosUn total de 34 pacientes completaron adecuadamente las valoraciones del primer experimento y 17 pacientes el segundo. El primer estudio arroja un punto de corte de 1,2uV, con un AUC del 87,7%; sensibilidad 84,2% y especificidad 80%. El segundo muestra un PC para los e. bipolares de 1,21uV (AUC 87,5%) y para los e. tetrapolares de 1,43 (AUC 82,5%) con un test de DeLong sin diferencias significativas entre ambas curvas (p>0,4065).ConclusionesLa metodología de validación con curvas ROC ha permitido obtener un nuevo PC para la prueba FR de modo práctico, simplemente simultaneando ambos test sobre el mismo grupo de pacientes hasta obtener una muestra significativa. (AU)

Introduction and objective: To obtain a new cut-off point (CP) for a lumbar flexion-relaxation (RF) test established with tetrapolar (e.) electrodes, from values already defined with bipolar devices.Materials and methodsThe study sample consists of 47 patients in a situation of temporary disability due to low back pain (DL). They were evaluated by means of an isometric dynamometry test, a kinematic test and an assessment of the FR phenomenon.Two experiments with ROC curves are proposed. The first, with 47 patients who consecutively performed the RF test with both types of electrodes, using the cut-off point (CP) known for the e. bipolar (2.49μV). In the second, with the EMG data recorded with e. tetrapolar in 17 patients, a DeLong test was performed that compares the 2 ROC curves that were constructed on the one hand, by classifying the sample from dynamometry and kinematic tests, and on the other, by classifying them with the bipolar EMG values.ResultsA total of 34 patients adequately completed the evaluations of the first experiment and 17 patients the second. The first study shows a cut-off point of 1.2μV, with an AUC of 87.7%; Sensitivity 84.2% and Specificity 80%. The second shows a PC for e. bipolars of 1.21μV (AUC 87.5%) and for e. tetrapolar values of 1.43 (AUC 82.5%) with a DeLong test without significant differences between both curves (p>0.4065).ConclusionsThe validation methodology with ROC curves has made it possible to obtain a new PC for the RF test in a practical way, simply by simultaneously performing both tests on the same group of patients until a significant sample is obtained. (AU)

[Progress of intraosseous basivertebral nerve ablation for symptomatic Modic alterations].

Chronic lumbar and back pain caused by degenerative vertebral endplates presents a challenging issue for patients and clinicians. As a new minimally invasive spinal treatment method, radiofrequency ablation of vertebral basal nerve in bone can denature the corresponding vertebral basal nerve through radiofrequency ablation of degenerative vertebral endplate. It blocks the nociceptive signal transmission of the vertebral base nerve, thereby alleviating the symptoms of low back pain caused by the degenerative vertebral endplate. At present, many foreign articles have reported the operation principle, operation method, clinical efficacy and related complications of radiofrequency ablation of the vertebral basal nerve. The main purpose of this paper is to conduct a comprehensive analysis of the current relevant research, and provide a reference for the follow-up clinical research.

Design of the COMEBACK and BACKHOME Studies, Longitudinal Cohorts for Comprehensive Deep Phenotyping of Adults with Chronic Low-Back Pain (cLBP): a part of the BACPAC Research Program.

Objective: The University of California, San Francisco (UCSF) Core Center for Patient-centric, Mechanistic Phenotyping in Chronic Low Back Pain (REACH) is one of the three NIH Back Pain Consortium (BACPAC) Research Programs Mechanistic Research Centers (MRCs). The goal of UCSF REACH is to define cLBP phenotypes and pain mechanisms that can lead to effective, personalized treatments for patients across the population. The primary objective of this research project is to address the critical need for new diagnostic and prognostic markers, and associated patient classification protocols for chronic low back pain (cLBP) treatment. Design: To meet this objective, REACH is conducting two large investigator-initiated translational research cohort studies called: The Longitudinal Clinical Cohort for Comprehensive Deep Phenotyping of Chronic Low-Back Pain (cLBP) Adults Study (comeBACK) and the Chronic Low-Back Pain (cLBP) in Adults Study (BACKHOME). Setting: comeBACK is a longitudinal multicenter in-person observational study of 450 adults with chronic low back pain designed to perform comprehensive deep phenotyping. While, the BACKHOME study is a site-less longitudinal observational e-cohort of approximately 3000 U.S. adults with cLBP. To our knowledge, BACKHOME is the largest prospective remote registry of nationwide adults with cLBP. Methods: Both the comeBACK and BACKHOME studies are collecting a robust and comprehensive set of risk factors, outcomes, and covariates in order to perform deep phenotyping of cLBP patients based on combined biopsychosocial variables to: define cLBP subtypes, establish phenotyping tools for routine clinical evaluation, and lead to improved cLBP outcomes in the future. The data from both studies will be used to establish techniques to develop a patient-centric definition of treatment success and to analyze cLBP patient traits to define clinically useful cLBP phenotypes, using a combination of traditional data analyses and deep learning methods. Conclusions: These 2 pivotal studies, in conjunction with the ancillary studies being performed in both comeBACK and BACKHOME, and the other BACPAC-consortium research projects, we will be able to address a number of diagnostic and therapeutic issues in this complex and diverse patient population with cLBP. These studies will help clarify biopsychosocial mechanisms of cLBP with the aim to provide a foundation to improve the evaluation of treatment effectiveness and to spur new avenues of therapeutic research, including personalized outcome measures that constitute a clinically meaningful treatment effect for individual cLBP patients.

Long-term impact of self-compassion training with core stability exercise on patients with nonspecific chronic low back pain: A randomized controlled trial.

OBJECTIVE: To compare the long-term effectiveness of self-compassion therapy (SCT) combined with core stability exercise (CSE) versus CSE alone in managing nonspecific chronic low back pain (NCLBP). METHODS: The combined group received SCT and CSE, while the exercise group only received CSE. Treatment was administered once weekly for four weeks, followed by one year of follow-up. The primary outcomes were changes in functional limitations (measured by Roland and Morris Disability Questionnaire scores[RMDQ]) and self-reported back pain (measured by the Numeric Pain Rating Scale[NRS]) at 52 weeks, with assessments also conducted at 2, 4, and 16 weeks. RESULTS: 52 (83.9%) completed the follow-up assessments and were included in the analysis (42 women [80.8%]; mean [SD] age,35.3 [10.0] years). In the combined group, the baseline mean (SD) RMDQ score was 9.3 (4.1),5.7 (5.8) at 2 weeks, 3.8 (3.4) at 4 weeks, 3.8 (3.7) at 16 weeks, and 2.4 (2.7) at 52 weeks. For the exercise group, the RMDQ scores were 8.2 (3.3) at baseline, 6.2 (4.2) at 2 weeks, 5.5 (4.7) at 4 weeks, 4.4 (4.5) at 16 weeks, and 5.2 (5.6) at 52 weeks. The estimated mean difference between the groups at 52 weeks was -3.356 points (95% CI, -5.835 to -0.878; P = 0.009), favoring the combined group. NRS scores showed similar changes. CONCLUSION: The addition of self-compassion therapy enhances the long-term efficacy of core stability training for NCLBP (Preregistered at chictr.org.cn:ChiCTR2100042810).

The Turkish minimum dataset for chronic low back pain research: a cross-cultural adaptation of the National Institutes of Health Task Force Research Standards.

BACKGROUND: The US National Institutes of Health (NIH) has produced a minimal data set to promote more accurate and consistent reporting of clinical trials, facilitating easier comparison of research on low back pain patients worldwide. The NIH-minimal dataset has not been previously translated into Turkish, and its features are currently unknown. This study aimed to adapt the NIH-Minimal Data Set into Turkish and investigate its validity and reliability in Turkish-speaking patients with chronic low back pain (CLBP). METHODS: In the study, 245 patients with CLBP were included. Test-retest and internal consistency analyzes were performed to evaluate the reliability of the NIH-minimal dataset. The intraclass correlation coefficient (ICC2,1) value was used to assess test-retest analysis. Cronbach's alpha value was calculated for internal consistency. Total impact scores of the NIH-minimal dataset were compared with total scores of the Roland Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI) to assess construct validity. The minimal detectable change (MDC95) was calculated based on the standard error of measurement (SEM95). RESULTS: The NIH-Minimal Data Set was found to have high test-retest reliability (ICC2,1 = 0.928) and high internal consistency (Cronbach α = 0.905). The NIH-minimal dataset correlated well with RMDQ and ODI (r = 0.750 and 0.810, respectively). There were no floor or ceiling effects. Also, SEM95 and MDC95 for the total score were 4.57 and 12.55, respectively. CONCLUSION: Considering all these data, it was concluded that the Turkish version of the NIH-minimal dataset is a valid and reliable outcome measure for evaluating patients with CLBP.

The associations between lumbar proprioception and postural control during and after calf vibration in people with and without chronic low back pain.

The relationships of lumbar proprioception with postural control have not been clarified in people with chronic low back pain. This study aimed to compare the associations between lumbar proprioception and postural control in response to calf vibration in individuals with and without chronic low back pain. In this study, we recruited twenty patients with chronic low back pain (CLBP group) and twenty healthy control subjects (HC group) aged between 18 and 50 years. This study was a cross-sectional study and completed from May 2022 to October 2022. The passive joint repositioning sense (PJRS) test for two positions (15° and 35°) were used to assess lumbar proprioception and expressed as the mean of reposition error (RE). Postural control was tested by adding and removing calf vibration while standing on a stable force plate with eyes closed. The sway velocity in the anterior-posterior (AP) direction of center of pressure (COP) data with a window of 15s epoch at baseline, during and after calf vibration was used to evaluate postural control. Mann-Whitney U-tests were used to compare the difference of lumbar proprioception between two groups, and the independent t-tests were used to compare the difference of postural control at baseline and during vibration, and a mixed design ANOVA was used to compare the difference of postural control during post-perturbation. In addition, to explore the association between postural control and lumbar proprioception and pain intensity, Spearman's correlations were used for each group. The major results are: (1) significantly higher PJRS on RE of 15° (CLBP: 95% CI [2.03, 3.70]; HC: 95% CI [1.03, 1.93]) and PJRS on RE of 35° (CLBP: 95% CI [2.59, 4.88]; HC: 95% CI [1.07, 3.00]) were found in the CLBP group; (2) AP velocity was not different between the CLBP group and the HC group at baseline and during calf vibration. However, AP velocity was significantly larger in the CLBP group compared with the HC group at epoch 2-14 after calf vibration, and AP velocity for the CLBP group took a longer time (23 epochs) to return to the baseline after calf vibration compared with the HC group (9 epochs); (3) lumbar proprioception represented by PJRS on RE of 15°correlated negatively with AP velocity during and after vibration for the HC group. Within the CLBP group, no significant relationships between PJRS on RE for two positions (15° and 35°) and AP velocity in any postural phases were found. In conclusion, the CLBP group has poorer lumbar proprioception, slower proprioceptive reweighting and impaired postural control after calf vibration compared to the HC group. Lumbar proprioception offers different information on the control strategy of standing control for individuals with and without CLBP in the situations with proprioceptive disturbance. These results highlight the significance of assessing lumbar proprioception and postural control in CLBP patients.

The correlation of trust as part of the therapeutic alliance in physical therapy and their relation to outcomes for patients with chronic low back pain.

BACKGROUND: Previous qualitative research has listed trust as a component of the therapeutic alliance in physical therapy. OBJECTIVE: Quantitatively correlate trust and therapeutic alliance in physical therapy care for patients with chronic low back pain. The secondary aim was to investigate the relation of trust and therapeutic alliance with outcomes over the course of treatment. METHODS: The Primary Care Assessment Survey was used to measure trust and the Working Alliance Inventory-Short Revised tool measured therapeutic alliance. The patient recorded these measures after the initial visit and at discharge. Self-report patient outcome measures for pain, function, and global rating of change were also measured at the same time points. RESULTS: A strong correlation (rs = 0.747 and rs = 0.801) was found between trust scores and therapeutic alliance measures post-initial visit and at discharge, respectively. In addition, there were moderate to strong correlations between trust and therapeutic alliance scores with the various improved outcome measures of pain, function, and global rating of change. CONCLUSION: There appears to be a connection between trust and therapeutic alliance along with improved patient outcomes related to higher trust and therapeutic alliance scores in a cohort with chronic low back pain.

Altered volume of the amygdala subregions in patients with chronic low back pain.

Background: Neuroimaging studies have suggested a pivotal role for the amygdala involvement in chronic low back pain (CLBP). However, the relationship between the amygdala subregions and CLBP has not yet been delineated. This study aimed to analyze whether the amygdala subregions were linked to the development of CLBP. Methods: A total of 45 patients with CLBP and 45 healthy controls (HCs) were included in this study. All subjects were asked to complete a three-dimensional T1-weighted magnetic resonance imaging (3D-T1 MRI) scan. FreeSurfer 7.3.2 was applied to preprocess the structural MRI images and segment the amygdala into nine subregions. Afterwards, comparisons were made between the two groups in terms of the volumes of the amygdala subregions. Correlation analysis is utilized to examine the relationship between the amygdala subregion and the scale scores, as well as the pain duration in patients with CLBP. Additionally, logistic regression was used to explore the risk of the amygdala and its subregions for CLBP. Results: In comparison to HCs, patients with CLBP exhibited a significant enlargement of the left central nucleus (Ce) and left cortical nucleus (Co). Furthermore, the increased volume of the left Ce was associated with a higher risk of CLBP. Conclusion: Our study suggests that the left Ce and left Co may be involved in the pathophysiological processes of CLBP. Moreover, the volume of the left Ce may be a biomarker for detecting the risk of CLBP.

Different montages of transcranial direct current stimulation on postural stability in chronic low back pain patients: A randomized sham-controlled study.

BACKGROUND: Impairment in both the motor and cognitive aspects of postural control is a critical issue in patients with chronic low back pain (CLBP) who experience high pain anxiety (HPA). OBJECTIVE: This study aimed to compare the effects of cathodal and anodal transcranial direct current stimulation (c-tDCS and a-tDCS) over the dorsolateral prefrontal cortex (DLPFC) on postural control during cognitive postural tasks in CLBP patients with HPA. METHODS: This study included 66 patients randomly assigned to three groups: DLPFC a-tDCS, DLPFC c-tDCS, and sham tDCS. All groups received 20 minutes of tDCS, but the stimulation was gradually turned off in the sham group. Postural stability indices were assessed using the Biodex Balance System. RESULTS: Both the a-tDCS and c-tDCS groups showed a significant reduction in most postural stability indices at static and dynamic levels after the interventions (immediately, 24 hours, and one-week follow-up) during the cognitive postural task (P< 0.01). Additionally, there was a significant improvement in postural balance in the a-tDCS and c-tDCS groups compared to the sham tDCS group (P< 0.01). Furthermore, the a-tDCS group showed significantly greater improvement than the c-tDCS group (P< 0.01). CONCLUSION: Based on the results, both a-tDCS and c-tDCS over the DLPFC had positive effects on postural control during cognitive postural tasks in CLBP patients with HPA.

The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial.

BACKGROUND: Chronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP. METHODS: This is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported. RESULTS: Medium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d = - .49). CONCLUSIONS: The findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03687762.

Healthcare Utilization (HCU) Reduction with High-Frequency (10 kHz) Spinal Cord Stimulation (SCS) Therapy.

Spinal cord stimulation (SCS) is a well-established treatment for patients with chronic pain. With increasing healthcare costs, it is important to determine the benefits of SCS in healthcare utilization (HCU). This retrospective, single-center observational study involved 160 subjects who underwent implantation of a high-frequency (10 kHz) SCS device. We focused on assessing trends in HCU by measuring opioid consumption in morphine milligram equivalents (MME), as well as monitoring emergency department (ED) and office visits for interventional pain procedures during the 12-month period preceding and following the SCS implant. Our results revealed a statistically significant reduction in HCU in all domains assessed. The mean MME was 51.05 and 26.52 pre- and post-implant, respectively. There was a 24.53 MME overall decrease and a mean of 78.2% statistically significant dose reduction (p < 0.0001). Of these, 91.5% reached a minimally clinically important difference (MCID) in opioid reduction. Similarly, we found a statistically significant (p < 0.01) decrease in ED visits, with a mean of 0.12 pre- and 0.03 post-implant, and a decrease in office visits for interventional pain procedures from a 1.39 pre- to 0.28 post-10 kHz SCS implant, representing a 1.11 statistically significant (p < 0.0001) mean reduction. Our study reports the largest cohort of real-world data published to date analyzing HCU trends with 10 kHz SCS for multiple pain etiologies. Furthermore, this is the first and only study evaluating HCU trends with 10 kHz SCS by assessing opioid use, ED visits, and outpatient visits for interventional pain procedures collectively. Preceding studies have individually investigated these outcomes, consistently yielding positive results comparable to our findings.

Influence of frailty status on the health-related quality of life in older patients with chronic low back pain: a retrospective observational study.

PURPOSE: Understanding the influence of frailty on health-related quality of life (HRQoL) in older individuals experiencing chronic low back pain can provide valuable insights into the impact of frailty. Therefore, the aim of our study is to assess how different frailty statuses among older outpatients with chronic low back pain affect their HRQoL. METHODS: Patients aged 60 and above with chronic low back pain were recruited from March 2022 to February 2023. Frailty was assessed via the frailty phenotype questionnaire, and HRQoL was evaluated using the EQ-5D-5L. Multiple regression models were used to explore the influence of frailty status on the EQ-5D-5L index and EQ-VAS. Logistic regression was used to determine odds ratios for the impact of frailty status on belonging to the lowest EQ-5D-5L index quartile. RESULTS: A total of 1,054 participants were classified into robust (29.8%), pre-frail (47.7%), and frail (22.5%) groups. Frailty was significantly associated with declining HRQoL. Pre-frail and frail statuses were inversely linked to the EQ-5D-5L index, with significantly higher odds of scoring in the lowest quartile compared to robust individuals. Stratification analysis identified sex as an effect modifier, emphasizing a more substantial association between frailty and the lowest EQ-5D-5L index quartile in female patients. CONCLUSIONS: A significant association exists between frailty and reduced HRQoL in patients with chronic low back pain. This association was predominant in female patients. Furthermore, considering the dynamic nature of frailty, early detection and effective interventions targeting pre-frailty are essential to delaying the transition to full frailty and improving HRQoL.

Cross-cultural adaptation and psychometric properties of the Thai version of the patient-reported outcomes measurement information system short form- depression 8a in individuals with chronic low back pain.

BACKGROUND: The study aimed to cross-culturally adapt the Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Depression 8a (PROMIS SF v1.0 - Depression 8a) into Thai and evaluate its psychometric properties in individuals with chronic low back pain (CLBP). METHODS: The PROMIS SF v1.0- Depression 8a was translated and cross-culturally adapted into Thai using the Functional Assessment of Chronic Illness Therapy translation methodology. Two hundred and sixty-nine individuals with CLBP completed the Thai version of PROMIS SF v1.0- Depression 8a (T-PROMIS-D-8a) scale and a set of measures assessing validity criterion domains. Structural validity, internal consistency, and test-retest reliability at a 7-day interval of the T-PROMIS-D-8a scale were computed and its construct validity was evaluated by computing correlations with the Thai version of Patient Health Questionnaire-9 (T-PHQ-9), Numeric Rating Scale of pain intensity (T-NRS), and Fear Avoidance Beliefs Questionnaire (T-FABQ). RESULTS: Data from 269 participants were analyzed. Most participants were women (70%), and the sample had a mean age of 42.5 (SD 16.6) years. The findings supported the unidimensionality, internal consistency (Cronbach's alpha = 0.94), and test-retest reliability (ICC [2,1] = 0.86) of the T-PROMIS-D-8a. A floor effect was observed for 16% of the sample. Associations with the T-PHQ-9, T-NRS, and T-FABQ supported the construct validity of the T-PROMIS-D-8a. CONCLUSIONS: The T-PROMIS-D-8a was successfully translated and culturally adapted. The findings indicated that the scale is reliable and valid for assessing depression in Thai individuals with CLBP.

Effect of aerobic exercises on patients with chronic mechanical low back pain: A randomized controlled clinical trial.

BACKGROUND: Chronic mechanical low back pain (CMLBP) is one of the most prevalent and costly disorders. Determining its most effective treatment approach is a priority for researchers. PURPOSE: To examine the effects of including aerobic exercise within a conventional therapy regimen for young adults with CMLBP. METHODS: Fifty CMLBP patients (22 males and 28 females) were randomly and equally assigned to one of two groups to receive the prescribed treatment for 8 weeks. The control group received the traditional program only (infrared, ultrasound, burst TENS, and exercises); for the experimental group, an aerobic training program using a stationary bicycle was added. Back pain intensity was the primary outcome. Secondary outcomes included the Oswestry disability index, back extensor endurance measured by the Sorensen test, and physical performance indicated by the back performance scale and the 6-min walk test. A Two-way MANOVA was used for data analysis. RESULTS: Multivariate tests revealed statistically significant effects of group (p = 0.002, partial η2 = 0.182), time (p < 0.001, partial η2 = 0.928), and group-by-time interaction (p = 0.01, partial η2 = 0.149). Univariate group-by-time interactions were significant for back disability (p = 0.043), extensor endurance (p = 0.023) and results of the 6-min walk test (p = 0.023) showing greater improvement in the experimental group. However, back pain intensity and the back performance scale revealed no significant group-by-time interactions. Within-group comparisons were significant for all measured variables in both groups (p < 0.001). CONCLUSION: Although a traditional program of infrared, ultrasound, TENS, and exercises is beneficial for CMLBP treatment, adding aerobic exercises to the program leads to more beneficial outcomes.

Five-Year Longitudinal Follow-up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

BACKGROUND: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS: At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION: Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).

The best exercise modality and dose for reducing pain in adults with low back pain: A systematic review with model-based Bayesian network meta-analysis.

OBJECTIVE: To quantify the dose-response relationship between overall and specific exercise modalities and pain, in patients with non-specific chronic low back pain (LBP). DESIGN: Systematic Review with Bayesian Network Meta-Analysis (NMA). LITERATURE SEARCH: We searched the Medline, Embase, Web of Science, Cochrane Library, Scopus, and SPORTDiscus databases from inception to June 2023. STUDY SELECTION CRITERIA: We included randomized controlled trials (RCTs) of exercise interventions in adults with non-specific chronic LBP and at least one pain outcome reported at the main trial endpoint. DATA SYNTHESIS: A random effects NMA was conducted. We assessed risk of bias using the Cochrane Risk of Bias Tool 2.0, and used the GRADE approach to judge the certainty of evidence for each outcome. RESULTS: Eighty-two trials were included (n=5,033 participants). We found a nonlinear dose-response relationship between total exercise and pain in patients with non-specific chronic LBP. The maximum significant response was observed at 920 METs-min (standardized mean difference = -1.74; 95% credible intervals: [-2.43, -1.04]). The minimum clinically-important difference (MCID) for achieving meaningful pain improvement was 520 METs-min per week. The dose to achieve MCID varied by type of exercise; Pilates was the most effective. The certainty of the evidence was very low to moderate for all outcomes. CONCLUSION: The dose-response relationship of different exercise modalities to improve pain in patients with non-specific chronic LBP had a U-shaped trajectory and low to moderate certainty evidence. The clinical effect was most pronounced with Pilates exercise.

The Emotion Regulation of Acupuncture in Chronic Low Back Pain: A Clinical Neuroimaging Protocol.

Introduction: Acupuncture is effective for patients with chronic low back pain (CLBP), which can relieve pain intensity and regulate negative emotional states such as pain-related anxiety and depression. Previous studies mainly discuss the analgesic mechanism of acupuncture treatment of CLBP, but there are multiple dimensions to pain, including sensation, emotion and cognition. Therefore, this study aims to investigate the central mechanism of acupuncture for CLBP from the perspective of emotional regulation by functional magnetic resonance imaging (fMRI). Methods and Analysis: A total of 72 patients with CLBP will be recruited in the study and randomly assigned to the verum acupuncture group or the sham acupuncture group. The trail will last for 18 weeks including a 2-week baseline, a 4-week treatment and a 12-week for follow-up period. The primary outcomes are the visual analog scale (VAS) and the Japanese Orthopaedic Association Scores (JOA) score. The secondary outcomes are the 12-item short form health survey (SF-12), the state trait anxiety inventory (STAI), the self-rating anxiety scale (SAS) and self-rating depression scale (SDS). The VAS, JOA, STAI SAS and SDS will be collected at baseline, week 2, week 4, and after follow-up. The SF-12 will be evaluated at baseline, week 2 and week 4. Functional magnetic resonance imaging (MRI) data will be collected at baseline and the end of treatment. Emotion-related brain regions will be chosen as regions of interest (ROIs). The gray matter volume (GMV), amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo), functional connectivity (FC), and large-scale functional brain network based on these ROIs will be analyzed within and between the two groups. Discussion: This study will verify the emotional regulation of acupuncture and explore the mechanism of acupuncture for emotion regulation in patients with CLBP. Trial Registration Number: https://www.chictr.org.cn/showproj.html?proj=195486, identifier: ChiCTR2300070557.

Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

BACKGROUND: Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. OBJECTIVE: This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga's effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. METHODS: For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. RESULTS: The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. CONCLUSIONS: The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56016.

The short- and long-term effect of osteopathic manipulative treatment on pain, and psychosocial factors in adults with chronic low back pain.

CONTEXT: Chronic low back pain (CLBP) has long plagued mankind, but little progress has been made in finding a rational and effective treatment, let alone a common cause. This study is an attempt to fill that void by measuring short- and long-term effects of osteopathic manipulative treatment (OMT), including psychosocial and pain reduction in CLBP patients. OBJECTIVES: The objectives of this study were to investigate the effectiveness of neuromusculoskeletal medicine/osteopathic manipulative medicine (OMM) in treating CLBP, with a focus on biopsychosocial (pain sensitivity questionnaire [PSQ]) and pain control in chronic conditions. METHODS: The study involved a large, single cohort observational design of 101 patients. The inclusion criteria for selecting patients targeted those with "nonspecific" CLBP. The National Institutes of Health (NIH) Minimum Dataset for Chronic Low Back Pain (NMD) was the measurement tool and was administered at consent (baseline), 2, 4, and 8 weeks and at 6 and 12 months. Time trends were analyzed as overall mean. Pairwise differences were compared between time points. Mixed-effects models were utilized to test the association of time with pain and biopsychosocial scores. RESULTS: Pain and PSQ scores decreased over the study timeline. The most significant change for both pain and biopsychosocial scores occurred at 6 months compared to baseline, with a further reduction at 12 months. CONCLUSIONS: OMT has been demonstrated to significantly reduce pain and psychosocial factors related to CLBP in both the short and long term.

Study on Vitamin D Levels in 30 to 40-Year-Old Females With Low Back Pain.

BACKGROUND: Vitamin D is associated with many skeletal-related processes in the body. A major health problem concerning decreased quality of life is chronic low back pain (LBP). Many studies have proved that chronic pain improves with Vitamin D supplementation. This study aimed to explore the correlation between vitamin D levels and the occurrence of LBP in women aged 30 to 40. MATERIALS AND METHODS: A case-control study was taken up at PK Das Institute of Medical Sciences wherein 50 cases (women aged 30-34 years who had chronic LBP >3 months) and 50 age-matched controls were included. Frequencies of Vitamin D deficiency, inadequacy, and sufficiency were studied. The t-test for examining statistical significance was employed to compare means. Keeping a 95% confidence interval (p<0.05), the odds ratio was calculated. RESULTS: Vitamin D deficiency diagnosed when Vitamin D level is <20ng/mL was found in 74% of cases and 48% of controls. Vitamin D levels were not found to be statistically different between cases and controls. The odds ratio was found to be 3.083 (p=0.009), showing that participants with LBP are more expected to be deficient in Vitamin D compared to those without LBP. CONCLUSIONS: Although a higher frequency of Vitamin D deficiency was found in cases compared to controls, the mean value of Vitamin D levels was not found to be statistically different amongst cases and controls. A significant Odds ratio establishes a positive association between LBP and Vitamin D deficiency. The reason could be due to most people being restricted indoors due to COVID-19 restrictions. It is essential to standardize the biochemical analysis of Vitamin D and establish appropriate Vitamin D level ranges specifically tailored for the Indian population.