Clinical Research Directory

Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion

Degenerative cervical disc disease can cause neck pain, nerve symptoms, dizziness, and problems with balance and head movement control. The neck contains many sensory receptors that provide information about head position and movement to the brain. When cervical discs degenerate or compress nearby structures, this sensory communication may be disrupted. As a result, patients may experience reduced accuracy and coordination of head movements. Anterior cervical discectomy and fusion (ACDF) is a standard surgical procedure used to relieve nerve or spinal cord compression caused by cervical disc disease. The procedure is effective in reducing pain and neurological symptoms. However, it is not well understood whether ACDF also improves the way the neck and nervous system work together to control head movement. The purpose of this study is to evaluate early changes in cervical movement control after ACDF. Patients scheduled for ACDF will be assessed before surgery and again one week after surgery. A group of healthy participants without neck pain will be assessed at the same time interval for comparison. Cervical movement control will be measured using a computer-based head-tracking task. During this task, participants follow a moving target on a screen using controlled head movements. The system records measures of tracking accuracy and timing. The primary research question is whether ACDF results in measurable short-term improvements in objective cervical movement control compared with healthy individuals over the same time period. It is hypothesized that patients undergoing ACDF will demonstrate improvement in specific movement-control measures after surgery. However, broader patterns of movement-control impairment may not fully normalize in the early postoperative period. The results of this study may improve understanding of how cervical spine surgery affects sensorimotor function and may help inform postoperative rehabilitation strategies.

Biologic Injection For Adults With Lumbar Disc Herniation

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.

Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery

Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.

Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, work loss and quality of life patient-reported outcomes

Proprio Spine Measurement Tool

This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries. Objectives Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively. Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes. Hypothesis The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.

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 Enabled Decision Support for Selection of Patients for Lumbar Spine Surgery

Background One third of patients operated for lumbar disc herniation (LDH) or spinal stenosis (LSS) do not achieve substantial improvement. Studies indicate that well informed shared decision making (SDM) can improve the selection to surgery, and thus the outcomes. Numerous algorithms for outcome prediction have therefore been developed, and some use artificial intelligence (AI). Most are trained on small datasets, few are accurate, all are stand-alone or web-based applications not integrated in the electronic health record (EHR), and none are implemented in routine clinical practice. The Norwegian registry for spine surgery (NORspine) comprises a cohort of more than 69,000 cases. The investigators have used AI to analyze the dataset and predict the outcome, and developed a decision support tool (DST) which is seamlessly integrated in the EHR DIPS Arena®. The investigators intend to use the tool to inform the SDM between surgeons and patients about the indication for surgery (yes or no), to increase the proportion with a successful outcome. The aim of the study is to assess the safety and feasibility of the DST for use in a subsequent pilot study. The device The DST (the device) is an integrate compound of software-solutions. Baseline data are registered by patients and surgeons on questionnaires integrated in DIPS Arena®, and transferred to NORspine. The data are also transferred (de-identified) to the AI-enabled prediction algorithm which operates in a cloud-based model hosting service. The algorithm has been trained and validated on a dataset from NORspine. The area under the curve for prediction of the main outcome (Oswestry disability index after12 months) in receiver operating characteristic analysis is very high (0.85) for LDH and moderate (0.72) for LSS. The model host also calculates outcomes (proportions with substantial, slight, or no improvement, and worsening) for the 50 cases with baseline variables most similar to the present case ("patients-like-me"). Finally, the individual prediction and the outcomes for the "patients-like-me" are transferred back and displayed in the regular user interface of DIPS Arena® for use in the SDM. Clinical investigations For this feasibility study, the investigators will use convergent qualitative and quantitative mixed methods. The comparator is decision making in routine clinical practice, without use of the DST. The study will include 20 patients with magnetic resonance imaging confirmed LDH or LSS referred for evaluation of the indication for surgery, and six surgeons who do the evaluations. The study will iteratively redesign the user interface of the DST until it is considered safe and feasible for use in a following pilot study.