Lumbar Radiculopathy

The purpose of this study is to determine the "Effects of Facilitated positional release technique vs manual myofascial release technique in female patietns with piriformis syndrome. we make 2 groups control and treatment group . we give FPRT technique to treatment group and manual release technique to control group in patients with piriformis syndrome. first we take base line readings of HIP ROMS( abduction, adduction, internal rotation, external rotation),NPRS and LEFS(lower extremity functional scale).. after 2 weeks of treatment again we take same readings and compare both readings.

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.

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.

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.

Project description - A pilot study on the safety of active conservative management of lumbar stress reactions grade 1 in adolescent soccer players Bone stress injuries are often classified as either high or low risk injuries. High risk injuries are those injuries at sites prone to progressing to a complete fracture and delayed/non-union whereas low risk injuries have a more favourable natural history and have little need for surgery or prolonged weight-bearing restrictions . Lumbar spondylolysis (LS) is traditionally classified as one of these high-risk injuries. LS is a bone stress injury in a vertebra. It occurs in the pars interarticularis, at times with additional posterior structures involved, and the most common site is L5 followed by L4. These injures can by graded from 0 to 4 according to the Hollenberg Classification. LBP is reported as a common problem in soccer and is experienced by more than half of the young soccer players. LS is reported to be the most common source of low back pain (LBP) in adolescent athletes, and the incidence in adolescent athletes is two to five times higher than that in nonathletes. One study found that 48% of adolescent male soccer players with LBP had LS. In the course of the primary investigators clinical work with talented adolescent soccer players the primary investigators encountered several cases of LS, most of whom were connected to academies. In the literature, only found five articles specifically focusing on this condition in adolescent soccer players were found. Studies show that if someone has a lumbar bone stress injury and cease to play football and other physical activities, they will most likely recover. This is in line with current treatment guidelines, classifying LS as a high-risk injury, and the recommended treatment is a minimum of three months of soccer cessation. However, it has also been shown that adolescent soccer players with bone marrow edema that continue to play doesn't necessary get worse, i.e. none of the studies report on any player getting a spondylolisthesis. One study found that 100% of the grade 1 injuries healed on MRI, while only 80% of grade 3 injuries recovered. This raises a question whether LS should be treated according to its grade instead of as a homogenous diagnosis, with grade 1 being a low-risk injury. This could potentially reduce the disadvantages that comes with current practice (3 months cessation of soccer), such as drop out from soccer, negative psychosocial effects and deconditioning with possible increased risk of new/other injuries at RTP. Therefore, this study aims to test an active pain explore the management of adolescent soccer players diagnosed with LS, focusing on those categorized with grade-1 spondylosis. The primary investigators believe a less conservative treatment approach based on symptoms and without worsening of radiological findings, aiming to minimize time away from sports participation, is justifiable in this group of patients, and that this approach offers substantial health, psychosocial, and performance-related benefits. This should ideally be compared to the current management approach in a randomized controlled trial; however, prior to this, a pilot study is important to establish the feasibility of the proposed approach. Study Type: Prospective cohort study - Pilot study Subjects and recruitment 30-40 subjects aged 14-19 will be recruited in collaboration with the Norwegian FA Sports Medicine Clinic (IHS) and local primary health care clinics connected to the IHS' network. The subjects all participate in organized soccer and are therefore covered by the national sports insurance, (incorporated in their soccer license). When injured, they report the injury to the insurance company who then books an appointment at IHS in Oslo or a local primary health care practitioner connected to the IHS network, and in this case either in Oslo or Bergen. This is standard procedure for all players and all injuries, and participants in this project will follow the same routine. IHS had 595 patients between the age of 14-19 with LBP in 2023 and studies indicate that approximately 50% of soccer players in this age group have LS (. Inclusion criteria: Soccer players with lumbar stress reaction grade 1 in L4 or L5. Age: 14-19. Pain in the area of the affected vertebrae with sports activity and/or ADL. Exclusion: Not able to get MRI, other conditions/injuries that potentially could affect the result (at baseline and during follow up), disorders influencing growth. Outcome measures Primary: Lumbosacral MRI including Volumetric interpolated breath-hold examination (VIBE)-protocol (at baseline and at three months). In patients younger than 18, MRI should be considered as the preferred study as MRI has been shown to have high diagnostic value, offering advantages over CT scans by avoiding ionizing radiation exposure (15). VIBE MRI has emerged as a valuable non-invasive imaging modality for assessing sports-related osseous pathology (16) and Ang et al.(17) compared 3D VIBE MRI with multislice CT for the detection of pars stress fracture morphology (complete, incomplete or normal) of the lumbar spine, concluding that 3D T1 VIBE is 100% accurate in diagnosing complete pars fractures and has comparative diagnostic ability to CT in the detection and characterization of incomplete pars stress fractures with sensitivity and specificity of 96.7 and 92% respectively. Secondary: Pain (NPRS): Numerical Pain Rating Scale (NPRS) The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is used to measure pain in adults and children 10 years old or older. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. For construct validity, the NPRS was shown to be highly correlated with the visual analogue scale (VAS) in which pain is shown spatially as distance along a straight line, in patients with rheumatic and other chronic pain conditions (pain\>6 months): correlations range from 0.86 to 0.95. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. A change of 2 points on the NPRS has been shown as a clinical meaningful change in LBP at 1 and 4-week follow-up. Function/disability: The Oswestry Low Back Pain Disability Questionnaire (ODI) is a condition-specific outcome measure for patients with low back pain, with acceptable to good measurement properties (20). It is a self-report scale for low back pain functional disability and has been validated for use in a wide range of languages, among them Norwegian. It is considered as 'gold standard' for low back pain. The Youth Back Activity Questionnaire (YouthBAQ) is a 14-item validated tool designed specifically to measure functional limitations in adolescents (12-18) with low back pain. YouthBAQ is scored on 0-100 scale with 100 representing no disability and 0 representing maximum disability. Level of activity: Data on weekly training load will be collected using the cellphone/mobile application AthleteMonitoring, where the participants will report minutes per week of sport specific and non-sport specific activity and adherence to home exercise program. This kind of load monitoring has been used in previous studies and have a protective effect against injury in adolescent athletes through intervention based on self-reported symptoms. Project timeline During the autumn of 2024 the investigators will gather focus groups consisting of players, coaches and parents and present the project including the research questions and adjust the project according to their feedback. In order to harmonize/homogenize the handling of each participant, the investigators will have a run through of all the outcome measures, physical examination and rehabilitation protocol with the therapists involved in the project. The data collection will start in 2025, and the investigators expect this to take between twelve and 18 months. Data analysis and writing the article will be done in 2026-27 (table 1). 2025 2026 2027 1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q 1st Q 2nd Q 3rd Q 4th Q Recruitment Data analyses Write-up For each subject, the timeline for data collection will be as follows (overview in table 2): Week 0 (first appointment with primary health care practitioner, ie. Physiotherapist) All adolescent soccer players that present with low back pain either at IHS in Oslo or the local primary health care practitioner connected to the IHS network in Bergen are potential candidates/participants in the project. They will have a standard anamnesis and physical examination, including ODI, NPRS, minutes of soccer and other physical activity per week, sleep and dietary habits. If there is a suspicion/risk of LS, the player will be referred to VIBE protocol MRI and will be asked to avoid pain provoking activities until the next appointment. Week 1 (second appointment with primary health care practitioner) If the MRI reveals a grade 1 LS, the player will be invited to participate in the project. If they accept, they will get a thorough explanation of the protocol, including answering questions weekly using the AthleteMonitoring app (see next section for details). Emphasis will also be on the importance of their feedback during the project, both when it comes to reporting activity and pain, but also on how they wish to carry out the protocol and at the same time stay in close contact with their team. Blood tests to exclude deficiencies and, if needed based on the anamnesis and blood samples, the players will be offered an appointment with a clinical nutritionist. Week 6 Evaluation using ODI and YouthBAQ Week 12 Evaluation using ODI and YouthBAQ MRI will be taken and if there is a regression or healing of the LS, no new MRI will be taken at week 26. If the LS is unchanged, the player will continue according to the protocol and will have a new MRI at week 26. If the LS has deteriorated/worsened, the player will follow the conservative treatment protocol, that is current (best) practice and will have a new MRI at week 26. Week 18 Evaluation using ODI and YouthBAQ Week 26 Evaluation using ODI and YouthBAQ Specific questions with regards to return to play, LBP, other injuries and pains and how they experienced the return to play, treatment protocol and their thoughts on the treatment protocol MRI when needed/as described above. Rehabilitation follow-up During the time of the project, the players will answer weekly questionnaires on NPRS lumbar spine (min. max. at rest, in ADL and in physical activity) and on weekly training volume (minutes per week of sport specific and non-sport specific activity), using an online survey software (AthleteMonitoring). The questionnaire will be delivered in the evening on the same day every week after all other activities (i.e. training and schoolwork) have likely been completed. Participants who have not replied to the initial questionnaire will receive a reminder 24 hours later and then manual follow-up if no response. The players will be followed up by their physiotherapist/primary health care practitioner approximately 5-8 times, depending on their progression, potential setbacks etc. and will always have the possibility to withdraw from the project (and continue the conservative treatment protocol, that is, current (best) practice. The specific intervention protocol, i.e. the different phases of rehabilitation, criteria for moving from one phase to the next, type of exercises etc. will be designed and described in accordance with the CERT check list. Analyses All collected data will be exported to SPSS or similar software and analyzed by Ben Clarsen in cooperation with the project leaders. Academic institution Western Norway University of Applied Sciences is responsible for this research project, in collaboration with the Norwegian FA Sports Medicine Clinic (Idrettens Helsesenter). Ethical approval Ethical approval was granted by the Regional committee for medical and health research ethics in Western Norway (REK Vest) and Data protection officer (NSD). Participating in the study will be quite similar to current standard practice with regards to imaging and number of visits. The participants will be followed closely with the weekly questionnaires and physical follow-ups to monitor and intervene early in case of adverse effects. The added load of use of time on additional MRI and weekly questionnaire will be minimal (approx. 10 minutes once a week) and can also be viewed as extra beneficial/thorough follow up by the participants. Therefore, the investigators do not expect significant problems in relation to ethical approval that cannot be resolved. All participants and parents/guardians will sign a declaration of content. They will be informed about data storage, and that they may withdraw from the study at any time without any consequences for them. Research data will be stored in accordance with the internal guidelines for secure data storage. The key to connect the participants' names to their number in the research (patient 1, patient 2 etc) will be stored on a password-protected PC. Only one project leader will have access to the connection key. All personally identifiable research data will be anonymized at the end of the project. The research project will be conducted in the absence of any commercial or financial relationships that could be seen as a potential conflict of interest. Funding Funding was granted by the The Norwegian Fund for Post-graduate Education of Physiotherapists. MRI's are covered by the participant's insurance (mandatory for all soccer players in organized sport) and is a standard practice for this group of patients. What this study adds The recent review by Wall et al. on LBP in adolescent athletes concludes: "Optimal diagnosis (including a better understanding between the relationship of imaging findings and clinical presentation), treatment and management methods for spondylolysis in this population should be better refined." If an active symptom-based management approach can be safely implemented, this could potentially reduce the disadvantages that comes with current practice (3 months cessation of soccer), such as drop out from soccer, negative psychosocial effects and deconditioning with possible increased risk of new/other injuries at return to sport. This will likely be a substantial improvement for the patient experience and overall health in the short term and long term. For the primary care physiotherapists treating these patients this study may provide a framework for active symptom-based management approach that could easily be implemented in current practice both to rehabilitate current injury and possibly decrease the risk of injuries related to 3-month cessation of training. This study is a first step in exploring LS rehabilitation and, if successful, may lead to further studies aiming to decrease the need for expensive MRI and altering management of LBP in this population. User participation When designing the treatment protocol, participants, coaches and other therapists have already been involved in giving feedback on wording, type of exercises and progression. Before starting the project, the investigators will gather focus groups consisting of players, coaches and parents and present the project including the research questions and adjust the project according to their feedback. Since the project aim to keep the participants in as much contact with their team as possible, the involvement of the participant and coaches and parents will be an important part when designing/personalizing the details of the rehabilitation for every individual player within the parameters set by the protocol. This will likely improve compliance, enjoyment and possibility of training more with the team than current guidelines allow. At 6-months follow up the participants will have the possibility to give feedback on their experience and opinions on the project and treatment protocol. It may be possible to invite participants to take part as patient voices during presentations of findings in congresses and courses etc. Project group/author list Bård Bogen, David Tovi and Nicolay Morland will be project leaders, in charge of the planning and day to day administration of the project. The University of Bergen is responsible for this research project, in collaboration with the Norwegian FA Sports Medicine Clinic (Idrettens Helsesenter). Follow-ups and data collection will be done by David Tovi, Nicolay Morland and Jan Henning Løken. Arne Larmo, Thomas Natvik, Ian Varley and Ben Clarsen contributes within their field of expertise when designing the project and will continue to do so when analyzing and presenting the data. Evidia will provide radiological examinations. Institution Name Role and Expertise Universtitet of Bergen / Haraldsplass Dianoness Hospital Bård Bogen Project leader, Physiotherapist PhD Tovi Fysioterapi David Tovi Project leader, Physiotherapist, Msc Vestland Idrettsmedinske Senter Nicolay Morland Project leader, Physiotherapist, Msc Idrettens Helsesenter Jan Henning Løken Physiotherapist, Msc Idrettens Helsesenter Joar Harøy Physiotherapist PhD Evidia Norway AS Arne Larmo Radiologist, MD Haukeland University Hospital Thomas Natvik Orthopaedic Surgeon, MD Nottingham Trent University Ian Varley Ass. Professor, Sports Scientist, PhD Oslo Sports Trauma Research Center Ben Clarsen Ass. Professor, Physiotherapist, PhD

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use. This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.

This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means. Subjects randomized to active treatment will undergo bone marrow harvest for processing into BRTX- 100 for intradiscal injection. Subjects randomized to control will also undergo a bone marrow and blood harvest but only undergo a sham intradiscal injection procedure. Subjects will return to the study site for a visit at Week 2, Week 12, Week 26, Week 52 and Week 104/Early Termination. The trial will have a Safety Run-In component that will insert a 3+3 design for the initial subjects dosed with BRTX-100 at 40 × 10\^6 cells. Specifically, the randomization scheme will be briefly shifted from the overall trial 2:1 randomization to an initial 3:1 allotment of intradiscal BRTX-100 versus control. As such, four subjects will initially be randomized and administered their agents. There will be a 14-day safety follow-up period that must elapse between dosing of each of the first four (4) subjects. Dosing of each subsequent subject in the Safety Run-In component cannot occur until the independent Medical Monitor (MM) reviews the previously dosed subject's blinded data, including but not limited to physical examination findings, laboratory values and reported adverse events (AEs) and serious adverse events (SAEs), at the completion of the 14-day visit and documents the findings. If no potential dose-limiting toxicity (DLT) is noted by the MM, the MM will approve the dosing of the next subject. If a potential DLT is noted by the MM, the MM will request that an ad hoc Data Safety Monitoring Board (DSMB) review of unblinded data occur per DSMB Charter before the next subject is dosed.