Clinical Research Directory

Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy

This study seeks to evaluate the use of intermittent dosing as an alternative paradigm for patients with DRG stimulation in place for at least 1 year and minimum 50% pain relief in the targeted area. Patients will be prospectively randomized to one of two stimulation paradigms both of which involve intermittent dosing at 30 seconds ON and 90 seconds OFF. Group 1 will have their frequency set at 20 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation). Group 2 will have their frequency set at 5 Hz with amplitude levels adjusted in order to remain in the therapeutic window (subthreshold stimulation) This study will be performed in a crossover fashion, meaning patients will be changed to the alternate dosing regimen at the 13-week time period. Patients will be seen and evaluated prior to randomization and reprogramming, and thereafter evaluated at 4, 8, and 12-weeks. At the 12-week time period, patients will begin a 1-week washout period of continuous stimulation. At the 13-week time period, patients will be evaluated, crossed over to the other study arm and thereafter evaluated at 17, 21, and 25-weeks.

Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy

Cervical radiculopathy is a common disease related to compression of the nerve roots of the spine (prevalence: 3.5/1000). Dysfunction and pain are the main repercussions and can lead to time off work and high costs in terms of treatment. Second-line surgical treatments appear to be less effective and present risks of side effects. In the first instance, treatments are conservative and include medication but above all physiotherapy with manual therapy, muscle exercises and cervical traction. These cervical tractions performed by a physiotherapist require little equipment and are inexpensive compared with the surgical alternative. They involve stretching the cervical spine and soft tissues to open the intervertebral foramen and mobilise the facet joints. Several authors have written summaries of their interest. Thoomes reports two studies and describes an absence of effect. In a meta-analysis, Romeo et al. added three more recent studies to the previous review and concluded that traction is effective, highlighting an "effect-dose" relationship. These recent results therefore seem to reverse the recommendations made barely two years later. Nevertheless, almost all the studies compared "manual therapy + exercises" with "manual therapy + exercises + cervical traction". Only Young et al. tested "manual therapy + exercises + cervical traction at an effective weight" compared to "manual therapy + exercises + cervical traction placebo at an ineffective weight". The study did not reveal any difference between the groups. However, several limitations appear in this study when comparing the protocol to studies that have shown efficacy. The main limitation is the low intensity (i.e. protocol with fewer sessions and longer duration). These clinical limitations may explain the lack of evidence of a positive outcome. Following on from a preliminary study evaluating an intensive cervical traction protocol over five days, and in order to discern the effect specific to the treatment (specific effect) and the effect independent of the nature of the treatment (contextual effect), the investigators wish to evaluate the impact of this intensive protocol by comparing it with placebo traction. In current practice, treatment varies between establishments. The paucity of studies on cervical traction in radiculopathy has resulted in routine use being guided by habit rather than evidence. It remains a clinical question which raises a major issue requiring a robust experimental design. Ultimately, this study follows on from a preliminary study and is part of a comprehensive research project aimed at proposing new recommendations for the use of traction in patients suffering from cervical radiculopathy. The investigators are investigating the impact of an intensive traction vs. placebo traction protocol in patients with cervical radiculopathy.

Exercise Therapy After Caudal Epidural Steroid Injection

\*\*Brief Summary\*\* Lumbar radicular pain arising from intervertebral disc herniation is commonly managed with a caudal epidural steroid injection (CESI), a minimally invasive procedure that delivers anti-inflammatory medication to the sacral hiatus. Although CESI affords short-term analgesia, a sizable proportion of patients continue to experience pain-related disability and diminished quality of life, underscoring the need for optimised post-injection rehabilitation. This single-centre, three-arm, parallel-group randomised controlled trial will evaluate the comparative efficacy of two evidence-informed exercise paradigms-moderate-intensity aerobic training and progressive lumbopelvic stabilisation-when each is superimposed upon a standard physiotherapy package of heat, therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS). Forty-two adults (18-70 years) with MRI-confirmed lumbar disc herniation who have undergone CESI at Çankırı State Hospital will be randomly allocated (1:1:1) to one of the following six-week interventions, initiated two weeks post-injection and delivered thrice weekly under physiotherapist supervision: 1. Conventional physiotherapy alone (heat + ultrasound + TENS). 2. Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down). 3. Conventional physiotherapy plus core-stabilisation exercise (phased activation of deep trunk musculature progressing to dynamic tasks on unstable surfaces). Primary end-points are pain intensity (10 cm Visual Analogue Scale) and back-specific disability (Oswestry Disability Index). Secondary end-points include generic health-related quality of life (SF-12) and lumbar proprioceptive body awareness (Fremantle Back Awareness Questionnaire). Outcomes will be captured at baseline, post-intervention (6 weeks) and at 3- and 6-month follow-up to ascertain both immediate and sustained effects. Study Question Does adjunctive aerobic or core-stabilisation exercise confer superior reductions in pain and disability, and greater gains in quality of life and body awareness, compared with conventional physiotherapy alone in adults following CESI for lumbar disc herniation? It is hypothesised that both exercise approaches will yield clinically and statistically superior outcomes relative to standard care, with stabilisation training providing the most durable functional benefits. Findings are expected to refine post-CESI rehabilitation algorithms and inform evidence-based clinical guidance for physiotherapists managing lumbar disc pathology.

Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection

This prospective observational study aims to develop artificial intelligence (AI)-based predictive models to estimate treatment response in patients with sciatica undergoing transforaminal epidural steroid injection (TFESI). Approximately 1500 adult patients diagnosed with sciatica and scheduled for TFESI at Marmara University Training and Research Hospital Algology Clinic will be enrolled. Clinical, radiological, laboratory, and psychological data will be systematically collected before the procedure and at multiple follow-up points (1 hour, 3 weeks, 3 months, and 6 months post-treatment). Pain relief, measured by a 50% or greater reduction in the Numeric Rating Scale (NRS), will be the primary outcome. The study will use these comprehensive data sets to train and validate AI algorithms, aiming to create a decision-support system that can predict individual patient responses to TFESI and improve personalized treatment planning.

Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

Strategic Use of Big Data in Spine Surgery - Testing Digital Prediction of Outcome in Clinical Praxis

The goal of this prospective, multicenter clinical trial is to determine if the use of the postoperative outcome prediction model the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction compared to current practice. The main questions it aims to answer are: * Does its use alter patient-reported outcome measured by general assessment regarding leg pain and Satisfaction in lumbar spinal stenosis? * Does its use alter patient-reported outcome as measured by general assessment regarding arm pain and Satisfaction in cervical rhizopathy? * How does the Quality of Life in patients - who after assessment by spinal surgeon do not proceed to surgery - compare with patients with the same baseline profile who did undergo surgery? Eligible participants will be presented with their predicted postoperative outcome generated by the Dialogue Support tool, as an adjunct to the ordinary assessment by a spine surgeon. Researchers will compare participants with a matched control group from the Swedish Spine Register ("Swespine") to see if the Dialogue Support tool can alter postoperative patient-reported outcome and satisfaction.

Impact of Muscle Degeneration in Chronic Low Back Pain

Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability. The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders

The primary objective is to use machine learning methods on large survey and health register data to identify participants with different treatment trajectories and health outcomes after surgical and/or conservative treatment for spinal disorders. Secondary objectives are to 1) conduct external validation of the prediction models, and 2) explore how the prediction models can be implemented into AI-based clinical co-decision tools and interventions.