Low Back Pain

This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using any standard anterior, standard lateral, or minimally invasive posterolateral surgical approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.

Purpose of Study: The purpose of this clinical trial is the clinical efficacy of different trigger modes of lever positioning manipulation (LPM) for the treatment of lumbar disc herniation (LDH). At the same time, the investigators considered from the perspective of virtual simulation and applied 3D finite element technology combined with dynamic capture system and mechanical sensing system to comprehensively evaluate the characteristics of biomechanical effects of different triggering modes of LPM on LDH. The main questions ansthe investigatorsred are: (1) To clarify what is the clinical effect of LPM in treating lumbar disc herniation?(2) Summarize the spatial motion laws and mechanical characteristics of the two triggering modes of LPM. Analyze the correlation betthe investigatorsen the LPM operation characteristics and the individual characteristics of LDH patients as the investigatorsll as the imaging parameters, and clarify the differences betthe investigatorsen the two LPM two trigger modes.(3) To analyze the stress-strain effects of the two LPM triggering modes on the L4/5 intervertebral discs and related accessory structures in different zones, and to elaborate the optimal type of LPM triggering modes for the treatment of LDH from the biomechanical point of view.(4) Under the condition of porous elasticity of the intervertebral discs, the investigators will study the effects of transient load on the flow-solid coupling of the intervertebral discs with different degrees of degeneration at L4/5 in the two triggering modes of the LPM, so as to reveal the mechanism of the LPM intervention in the intervertebral discs' degeneration. The main research includes the following four aspects: (1) Clinical efficacy study and standardized data collection of LPM.This study plans to recruit 128 volunteers from the Third Hospital Affiliated to Zhejiang University of Traditional Chinese Medicine will be recruited for the study. Sixty-four LDH patients and 64 healthy volunteers the investigatorsre planned to be included in this study. The LDH patients the investigatorsre divided into lever positioning manipulation group (group 1, n=32) sham manipulation group (group 2, n=32) using random number table method. In this group, unilateral wrenching mode was used for patients with paracentral LDH and bilateral wrenching mode was used for patients with central LDH. Manipulation was performed every two days, receiving a total of 6 sessions over 2 the investigatorseks. Healthy volunteers the investigatorsre similarly categorized into unilateral trigger mode group (group 3, n=32) bilateral trigger mode group (group 4, n=32) using random number table method. LPM treatments the investigatorsre administered every two days, receiving a total of 6 sessions over 2 the investigatorseks. Participants in both Group 1 and Group 2 the investigatorsre required to complete clinical questionnaire assessments, including the Visual Analog Scale (VAS) and the Japanese Orthopaedic Association (JOA) scoring system. During the LPM operation, the performer wore a mechanical sensing glove to collect the mechanical parameters of the maneuver, while a motion capture system was used to collect the kinematic parameters of the LPM, and the individual characteristics and imaging parameters of all the volunteers the investigatorsre collected, so as to analyze the correlation betthe investigatorsen the mechanical parameters, kinematic parameters, and the individual factors of the patients with LDH.(2) Virtual simulation model building and maneuver loading analysis.One standard volunteer was selected among 64 healthy volunteers, and the lumbar spine-pelvis imaging CT data the investigatorsre imported into Mimics software for geometric model extraction and preliminary processing. Geomagic and other software the investigatorsre utilized to construct the lumbar spine 3D finite element simulation model. And based on Abaqus CAE finite element simulation software, two kinds of wrenching mode maneuvers of LPM the investigatorsre simulated and loaded. The kinematic and mechanical parameters of the LPM the investigatorsre disassembled and loaded into each model to obtain the analytical models of manipulation in different trigger modes. The experimental results the investigatorsre obtained by calculating and analyzing the working conditions of LPM through Abaqus software. Observe the stress and strain on the intervertebral disc and ancillary structures under the action of LPM in different pulling modes.(3) Fluid-solid coupling effect of LPM on lumbar intervertebral disc under transient loads.Under the condition of considering the porous elasticity of the intervertebral disc, the coupled flow-stress simulation in Abaqus CAE was utilized to study the coupled flow-solid effect of the intervertebral disc, and then loaded to simulate the LPM manipulation, and observed the changes such as the stress displacement of the intervertebral disc under the manipulation.

This study is designed to assess the impact of structured exercise interventions on pain and functional outcomes in otherwise healthy adults with low back pain. Eligible participants recruited from the community will be randomised into one of three arms: (1) control group, continuing their usual exercise activities; (2) running intervention group; or (3) swimming/cycling intervention group. The two intervention arms will complete an 8-week combined exercise programme consisting of aerobic training (running or swimming/cycling, depending on group assignment), progressive resistance training, and prescribed flexibility exercises. The programme is structured to gradually increase in intensity over the 8-week period to enhance adherence and minimize risk of injury. Efficacy will be evaluated using validated patient-reported outcome measures (PROMs) capturing pain intensity and functional capacity. These assessments will be administered at three time points: baseline (prior to the intervention), post-intervention (8 weeks), and long-term follow-up (12 months). This design will enable analysis of both the short-term and sustained effects of exercise modality on low back pain management.

Low back pain (LBP) is the leading cause of disability worldwide and is costly. Lifestyle factors, such as physical inactivity, stress, sleep, excess weight, and an unhealthy diet contribute to the burden of LBP and the associated increasing demand for care. Moreover, approximately 65% of LBP patients who visit the hospital are overweight. This group is considered a complex patient group. Of the LBP patients who visit the hospital, 74% are referred back to primary care as medical specialists cannot offer them high value care. Targeting both lifestyle factors (e.g., physical activity, sleep and stress) and clinical factors related to low back pain (e.g., muscle strength, endurance, mobility) is important in the management of this group of LBP patients to improve important outcomes (e.g., functioning, physical activity) and reduce costs. Addressing lifestyle factors may also offer additional health benefits like decreased risks of diabetes and cardiovascular diseases. The primary objective of this project is to improve the management of this complex group of LBP patients, that is, patients who are overweight or obese and who are referred back to primary care from the hospital because medical specialists cannot offer them high value care, and to reduce healthcare and societal costs. The primary research question is: 'Is a combined lifestyle intervention, integrated into standard care for LBP, delivered by physio/exercise therapists effective and cost-effective in improving physical functioning and/or physical activity over a 36-month period compared to usual care in overweight or obese LBP patients who are referred back from the hospital to primary care?' It is hypothesized that the combined lifestyle intervention, integrated into standard care for LBP, is both effective and cost-effective in managing LBP in patients who are overweight or obese over a 36-month period.

Postoperative nausea and vomiting (PONV) remains a common adverse event after surgery and anaesthesia causing much dissatisfaction among patients. PONV incidence is reported at 30% in all surgical patients and up to 80% in high-risk patients. Idiopathic scoliosis is a common form of structural spinal deformities with a Cobb angle of \>/ 10 degrees. It affects young females in the early pubertal stage more than young men by 1% and 4%. Posterior spinal fusion (PSF) surgery is commonly performed in patients with severe scoliosis. It is a long complex surgery inflicting extensive surgical field requiring opioids as the mainstay of analgesia during the perioperative period. These targeted population are particularly adolescent female requiring intraoperative and postoperative opioids who are at high risk of developing PONV. Dexamethasone and anti-serotonergic drugs like granisetron are commonly used antiemetics due to their efficacy and safety profiles. Dexamethasone is particularly favoured for its long duration of action and pain-reducing effects. Palonosetron, a second-generation anti-serotonergic drug, has a unique pharmacokinetic profile with a prolonged duration of action. It may be more beneficial for patients on prolonged opioid-based analgesic regimens. However, its higher cost and inconsistent study findings limit its widespread use, especially in scoliosis patients undergoing spinal fusion surgery. Total intravenous anaesthesia (TIVA) is recommended for high-risk PONV patients, as it reduces the emetogenic effect of volatile anaesthetics. Propofol, used in TIVA, is itself an effective antiemetic. TIVA with propofol has been shown to be as effective as giving a single antiemetic and can further reduce the risk of PONV when combined with other prophylactic antiemetics. The standard practice for managing PONV involves the administration of two antiemetics and considering TIVA for high-risk patients. This study aims to compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone in scoliosis patients undergoing spinal fusion under TIVA. The study will also evaluate the number of rescue antiemetics needed, assess adverse effects, and measure patient satisfaction. The study will be randomized and double-blinded, to be conducted in University Malaya Medical Centre (UMMC). The sample size is calculated to be 92 participants, after taking into account a 20% dropout rate. Adult and adolescent idiopathic scoliosis patients undergoing PSF surgery will be eligible for the study. Written informed consent will be obtained from participants or their guardians, and assent will be obtained from adolescent participants. Patients will be randomized to receive either palonosetron or ondansetron along with dexamethasone. The study will follow standard anaesthetic techniques, including TIVA with remifentanil and propofol. Intravenous injections of the study drugs or placebo will be given during surgery, and dexamethasone will be administered as a baseline antiemetic. Morphine will be administered before the end of surgery for pain management.

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing. Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Low back pain is a common problem that many adults experience at some point in their lives. One treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. So far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. This study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. By understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. The goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care. Eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. At 3 of those sessions, participants will receive dry needling to their low back. As part of the research, participants will complete questionnaires related to how pain effects their life. Participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity. To be included in this study participants must: * Be 18-65 years of age * Have low back pain for at least 3 months

After a 12-month milestone-driven planning and preparation phase, we will conduct a 21-month randomized feasibility clinical trial of the embedded ED physical therapy intervention at the Northwestern Medicine and University of Utah health systems, comprised of 9 months of active intervention and 12 months of longitudinal data collection. Two hospital EDs (Northwestern Memorial Hospital, University of Utah Hospital) will be randomized to receive either the embedded ED physical therapist intervention (treatment, n=1) or usual care (control, n=1). Following completion of the feasibility trial, the control site will receive the intervention as per standard waitlist procedures for randomized trials. A third hospital ED (Northwestern Lake Forest Hospital) will not participate in randomization or participant enrollment but will contribute baseline electronic health record data to assist in feasibility assessments for a future full-scale trial.

Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, and can often become an intractable condition with long-term outcomes unimproved by conventional biomedical treatments such as surgery. Thus, we seek to develop a non-invasive and non-pharmacologic treatment for LR patients This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain. The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment. During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention. This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.

Using an effectiveness-implementation hybrid type I design, this study aims to test the effectiveness of a multilevel intervention in primary care for patients with LBP and investigate the implementation processes. The primary objectives are to test the effectiveness of a multilevel intervention in primary care for patients with low back pain (PRIME: PRImary care MultilEvel intervention for low back pain) compared with usual care in terms of: (1.1) Cost-effectiveness (system-level) (1.2) Imaging prescription rate (practitioner-level); (1.3) Self-reported back-related disability (patient-level). Secondary objectives are: 2.1 To evaluate the effectiveness of the PRIME intervention on opioid prescription rate and sick leave days prescription by general practitioners (practitioner-level) 2.2 To evaluate the effectiveness of the PRIME intervention on pain intensity, work participation, health-related quality of life, global perceived change, Pain Self-Efficacy, Fear Avoidance Beliefs, and beliefs about LBP (patient-level) 2.3 To evaluate the effectiveness of the training on clinicians' beliefs about LBP and confidence in treating patients with LBP (practitioner-level) As an effectiveness-implementation hybrid design type 1 study, implementation process outcomes are secondary objectives. These include: (3.1) evaluating the acceptability, appropriateness, feasibility, fidelity and adoption of the multilevel intervention among general practitioners, physiotherapists and occupational therapists; (3.2) exploring barriers and facilitators to the implementation of the multilevel intervention among healthcare practitioners; (3.3) exploring the experience of a biopsychosocial 2-day experiential workshop among trained physiotherapists; (3.4) exploring the experience and acceptability of the multilevel intervention among patients. The study is a cluster randomized controlled trial, with the unit of randomization being quality circles of general practitioners affiliated with a care network in the French-speaking part of Switzerland. A total of 20 quality circles will be randomized into intervention and control arms. Each quality circle includes multiple general practitioner practices, and approximately 100 general practitioners will participate in total. General practitioners in the intervention group will receive a multilevel intervention including: general practitioners training, reminders, tools for patients education and a dedicated clinical pathway. The clinical pathway includes a gradual stratified care pathway based on risk factors for chronicity. The core interventions of this 3-step clinical pathway are education and self-management, individual sessions with a trained physiotherapist, and multidisciplinary group management. Physiotherapists providing individual sessions in the intervention group will all have participated in a two-day workshop to improve their knowledge of good clinical practice and develop their competence to manage risk factors of chronicity within a biopsychosocial framework. They will be trained to address unhelpful beliefs and avoidance behaviors through good communication and gradual exposure exercises, as improving unhelpful beliefs and reducing kinesiophobia are important mediators of successful rehabilitation. If general practitioners recommend multidisciplinary group management, patients will receive a comprehensive assessment of risk factors and tailored education by an experienced occupational therapist. If this confirms the need for multidisciplinary group management, patients will receive a structured outpatient multidisciplinary group rehabilitation for LBP that specifically targets physical and psychological factors. The clinical pathway provides advice to general practitioners at three stages: In the first consultation, general practitioners will screen for red flags, reassure and explain LBP to patients with the above-mentioned resources, and prescribe medication if needed. They will also decide whether the patient needs to immediately start physiotherapy sessions with a trained physiotherapist. Ten days after the first consultation, patients will receive an SMS/email directing them to an online questionnaire that assesses risk factors of chronicity (Start Back Tool) and their ability to work. General practitioners will automatically receive via email a summary of the risk of chronicity (low, medium or high) and the patient ability to work. The email will only communicate the current state of the patient and the general practitioner is free to decide whether to follow the clinical pathway recommendation, as independence of practice is also important for implementation. If the patient has already been prescribed trained physiotherapy, it is suggested that nothing is changed at that time (10 days), independent of the level of risk. Coordination of care with the physiotherapist is strongly advised in this case. In case physiotherapy has not yet been prescribed, general practitioners are advised the following: (i) If the patient is able to work normally and has a low risk of chronicity, he or she should continue to self-manage and the general practitioner should decide to organize a follow-up meeting based on the patient needs; (ii) If the patient has a medium or high risk of chronicity, or is still not able to work normally because of LBP, the general practitioner is advised to prescribe 6 sessions of trained physiotherapy (with the possibility to prescribe additional sessions in the future). At 6 weeks after the first consultation, patients will receive another SMS/email with the same questionnaire to fill out, and general practitioners will receive the automated email again. At 6 weeks, general practitioners will be advised the following: (i) If the patient is able to work normally and has a low risk of chronicity, it is probable that the patient has recovered. Therefore, no new treatment should be started and physical activity should be promoted. A follow-up consultation can be organized if needed. (ii) If the patient is able to work normally and has a medium risk of chronicity, prescription of trained physiotherapy would be advised for 6 sessions if not yet started. If physiotherapy was already started and the patient is improving, 6 additional sessions could be offered at this stage based on patient and physiotherapist reports; (iii) If the patient is not able to work normally or has high risk of chronicity, general practitioners would be advised to offer a comprehensive assessment of risk factors and tailored education by a specialized occupational therapist. If this confirms the need for multidisciplinary treatment, multidisciplinary management could be started. Importantly, for patients that have already started physiotherapy, physiotherapists and general practitioners are advised to work together to coordinate care, as interprofessional collaboration was highlighted to be a critical point in the pilot study. The primary effectiveness outcomes include patient-reported back-related disability (measured by the Roland-Morris Disability Questionnaire), the proportion of patients referred for spinal imaging within three months, and the incremental cost per quality-adjusted life year (QALY) gained. Secondary patient outcomes include pain intensity, health-related quality of life, work participation, pain self-efficacy, fear avoidance beliefs, general beliefs about LBP, and global perceived improvement. Practitioner-level outcomes include opioid and sick leave prescription rates, as well as changes in GP confidence and beliefs about LBP. General practitioners in the control group will have no specific training or intervention and will treat patients according to their usual practice. Implementation outcomes are evaluated using both quantitative and qualitative methods. These include the acceptability, appropriateness, feasibility, adoption, and fidelity of the intervention among general practitioners, physiotherapists, and occupational therapists. The experience of the physiotherapists who complete a two-day biopsychosocial training workshop is also explored. Patient perspectives on the acceptability of the intervention will be collected through interviews or focus groups. Patients data collection will occur at baseline and at 10 days, 6 weeks, 3, 6, 9, and 12 months. Patients complete questionnaires online via REDCap at each time point. Administrative data and prescribing behavior are also collected to complement self-reported outcomes. General practitioners will complete questionnaires before and after training and at the end of the recruitment period. Focus groups and interviews with healthcare professionals and patients will be recorded, anonymized, transcribed, and analyzed using thematic analysis. The target sample size is at least 500 patients, with approximately 25 per cluster. Recruitment may exceed this number to ensure that a minimum of 200 patients per group complete the 6-month follow-up. The study has been powered to detect a minimal clinically important difference of 2.5 points on the Roland-Morris scale, assuming a standard deviation of 6 and an intracluster correlation coefficient (ICC) of 0.05. Analyses will be conducted according to the intention-to-treat principle, using linear and generalized linear mixed models to account for clustering. Cost-effectiveness will be assessed from both the healthcare payer and societal perspectives using the EQ-5D-5L.