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Spinal Diseases clinical trials

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NCT ID: NCT04642625 Completed - Pain, Postoperative Clinical Trials

Comparison of Ultrasound-guided Bilateral ESP Block and Wound Infiltration for Spinal Surgical Analgesia

Start date: April 1, 2021
Phase:
Study type: Observational

The aim of our study is to determine the superior procedure in analgesia management by comparing the traditional wound infiltration technique with the ultrasound-guided bilateral erector spina plan block technique in spinal surgery patients.

NCT ID: NCT04578691 Completed - Spinal Tumor Clinical Trials

Study to Evaluate the Safety and Clinical Outcome of Using Navigation System in Pedicle Screw Placement in Spine Surgery

Start date: June 29, 2020
Phase: N/A
Study type: Interventional

The research project is testing whether in screw insertion of spine surgery using "Anatase" Spine Surgery Navigation System is at least as safe and accurate as using O-arm assisted spine surgery- Medtronic Stealthstation S7 Treatment Guidance System.

NCT ID: NCT04545983 Completed - Spinal Stenosis Clinical Trials

Long-term Follow-up Motion Analysis of ACD Versus ACDA

Start date: February 12, 2022
Phase: N/A
Study type: Interventional

Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment. Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA. Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial. Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery. Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made. Main study parameters/endpoints: The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.

NCT ID: NCT04490291 Completed - Chronic Pain Clinical Trials

An Observational Study of Integrated Chronic Pain Management in a Community Health Center

Start date: August 1, 2018
Phase:
Study type: Observational [Patient Registry]

This was a prospective observational study with the primary objective of quantifying a change in pain scores after 6-12 months of two separate interventions within the study site (pain team and chiropractic team). Target enrollment was 30 participants for each intervention. The primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily dose, and its effect on PDQ scores.

NCT ID: NCT04391855 Completed - Pain, Postoperative Clinical Trials

Wound Infiltration With Tramadol, Dexmedetomidine, or Magnesium Plus Ropivacaine for Pain Relief After Spine Surgery

Start date: May 10, 2020
Phase: Phase 4
Study type: Interventional

The rationale for multimodal analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitization. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period. Peri-incisional injection of local anesthetics is an effective method for pain relief after many surgical procedures, as it can reduce postoperative analgesic consumption. Ropivacaine is a propyl analog of bupivacaine with a longer duration of action with a much safer cardiotoxicity profile than bupivacaine. Thus, a combination of local anesthetic with other analgesic factors, such as opioids, dexmedetomidine, clonidine, ketamine, magnesium sulfate, dexamethasone is suggested for a better analgesic outcome. Dexmedetomidine, a highly selective a2-adrenergic receptor agonist, has been the focus of interest for its broad spectrum (sedative, analgesic, and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications. The intravenous, intramuscular, intrathecal, epidural, and perineural use of this agent enhances analgesic effects. Tramadol hydrochloride is a synthetic analog of codeine that acts on both opioid (weak m receptor agonist) and nonopioid receptors (inhibits the reuptake of noradrenaline and serotonin as well as release stored serotonin from nerve endings) which play a crucial role in pain inhibition pathway. It also blocks nerve conduction which imparts its local anesthetics like action on peripheral nerves. It was reported that NMDA antagonists could prolong the analgesic effect of bupivacaine to even a week, as well as inhibit hyperalgesia. Magnesium sulfate (MGS) is a non-competitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect and is essential for the release of acetylcholine from the presynaptic terminals and, similar to calcium channel blockers (CCB), can prevent the entry of calcium into the cell. Aim of the study is to evaluate and compare the postoperative analgesic efficacy of tramadol, dexmedetomidine, and magnesium when added to ropivacaine as an adjuvant for wound infiltration following spine surgery.

NCT ID: NCT04194788 Completed - Clinical trials for Orthopedic Disorder of Spine

Olfaction Changes in Patients Undergoing Spine Surgery

Start date: April 29, 2021
Phase:
Study type: Observational

This observational prospective study evaluates perioperative olfaction alterations, comprising changes in threshold value, discrimination and identification, which occur in spine patients. The single group is subjected to a preoperative and a postoperative assessment.

NCT ID: NCT04171544 Completed - Spinal Disease Clinical Trials

Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up

OCT PMCF
Start date: August 6, 2019
Phase:
Study type: Observational

This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.

NCT ID: NCT04161729 Completed - Pain, Postoperative Clinical Trials

Effects of Intraoperative Magnesium Sulfate on Perioperative Pain Relief After Spine Surgery

Start date: January 28, 2020
Phase: Phase 4
Study type: Interventional

The treatment of postoperative pain is increasingly based on a multimodal approach and although opioids remain the drug of choice, they are often used in combination with other analgesics (paracetamol, cyclooxygenase inhibitors or non-steroidal anti-inflammatory drugs) and co-analgesic agents (clonidine and anti- NMDA such as ketamine or MgSO4). The rationale for combined analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitisation. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period. Although magnesium is not a primary analgesic in itself, it enhances the analgesic actions of more established analgesics as an adjuvant agent. Magnesium produces a voltage-dependent block of NMDA receptors and has been reported to have analgesic properties that might be related to this inhibiting property. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by noxious stimuli. When magnesium was used intraoperatively, many researchers reported that it reduced the requirement for anesthetics and/or muscle relaxants. Intraoperative use of magnesium sulfate can also be associated with decreased incidences of nausea and vomiting after surgery, which could have been due to the lower consumption of anesthetics (i.e. volatile agents), rather than any antiemetic effect of magnesium sulfate. In addition, perioperative i.v. administration of magnesium sulfate has another advantageous effect, as it decreases the incidence of shivering by up to 70-90%. Previous studies investigating the analgesic efficacy of MgSO4 in general, gynaecological, ophthalmic and orthopaedic surgery have shown conflicting results, while reports regarding spine surgery are extremely limited. Our study was designed to investigate the effects of MgSO4 on perioperative pain relief and postoperative quality of recovery after lumbar laminectomy surgery.

NCT ID: NCT04156867 Completed - Clinical trials for Orthopedic Disorder of Spine

Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.

NCT ID: NCT04119466 Completed - Clinical trials for Degenerative Disc Disease

Stabilizing Training in Degenerative Disc Disease

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.