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Spinal Fusion clinical trials

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NCT ID: NCT05354830 Completed - Pain, Postoperative Clinical Trials

The Effect of Foot Massage on Pain, Sleep Quality and Early Discharge in Patients Undergoing Spinal Surgery

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

In recent years, it is known that the use of complementary approaches, which are accepted as a safe and effective method for maintaining health and well-being, providing relaxation/relaxation, and reducing the effects of illness, has been increasing. It is reported that massage, which originates from an instinctive need for touch and is one of the oldest treatment methods, was first described in China in the second century BC and immediately after in India and Egypt, and was widely used by other early cultures such as Arabs, Greeks, Italians and Romans. In papyruses, on rocks, and in ancient oral stories dating back 15,000 years, there is evidence of the use of hands to provide comfort and healing. It is stated that foot massage, which is one of the most frequently used massage types today, has been applied in different parts of the world such as Egypt, India and China for thousands of years. In addition to pharmacological methods, non-pharmacological complementary and alternative treatment methods are also used in the control of pain due to reasons such as dissatisfaction with traditional treatment methods, reluctance to use invasive procedures and daily analgesics, and the toxic effects of drugs. Massage provides relaxation both physically and mentally. It is thought to reduce edema by accelerating circulation, muscle tension and anxiety by the stimuli reaching the spinal cord, and pain sensation by stimulating peripheral sensory receptors.

NCT ID: NCT05345249 Completed - Clinical trials for Lumbar Spinal Stenosis

Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery

RCT-ESPB
Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity. Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo. Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial. Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels. Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery. Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.

NCT ID: NCT05323448 Recruiting - Spinal Fusion Clinical Trials

Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.

NCT ID: NCT05311826 Completed - Exercise Clinical Trials

Diaphragmatic Breathing Exercise for Patients Undergoing Arthrodesis Surgery for Adolescent Idiopathic Scoliosis.

Start date: June 29, 2022
Phase: N/A
Study type: Interventional

After spinal surgery, diaphragmatic breathing exercise can be a low-cost and extremely safe intervention that can be introduced for pain management. The aim of the study is to investigate the effectiveness of diaphragmatic breathing exercise in the management of pain in the postoperative care in patients undergoing spinal fusion for adolescent idiopathic scoliosis.

NCT ID: NCT05299762 Recruiting - Spinal Fusion Clinical Trials

A Post Market Surveillance on INFUSE Bone Graft

Start date: August 10, 2022
Phase:
Study type: Observational

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

NCT ID: NCT05287035 Enrolling by invitation - Spinal Fusion Clinical Trials

Spinal Fusions Steroid Study

SFSS
Start date: July 1, 2023
Phase: Early Phase 1
Study type: Interventional

Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.

NCT ID: NCT05273879 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups. This trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.

NCT ID: NCT05195593 Recruiting - Scoliosis Clinical Trials

Spine Registration Using 3D Scanning - Arise

Start date: January 5, 2022
Phase:
Study type: Observational

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

NCT ID: NCT05195580 Recruiting - Scoliosis Clinical Trials

Spine Registration Using 3D Scanning

Start date: August 31, 2021
Phase:
Study type: Observational

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.

NCT ID: NCT05190055 Active, not recruiting - Spinal Fusion Clinical Trials

Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery

Start date: March 25, 2015
Phase: N/A
Study type: Interventional

Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were recruited. The follow-up period was 24 months for each participant. The eligible patients for this study should be above 18 years old with confirmed indication to TLIF through a posterior approach. Patients with an active infection, symptomatic osteoporosis, immature bone, pregnancy, active malignancy, and previous radiotherapy at the planned surgical site were excluded. Informed consent was signed by each participant before recruitment. We strictly followed the protocols of patient confidentiality and human subjects in the clinical trial implementation. The patients were blinded to the allocated surgical technique before the operation and during the follow-up period of two years. On the one hand, the doctor will assess the patient's physiological function recovery and imaging examinations (such as CT, MRI or X-ray) before and after the operation to understand the changes in the patient's pain index and the effect of intervertebral disc fusion after the operation; on the other hand, It also evaluates the quality of life and the degree of improvement of psychological emotions through the questionnaires of patients before and after surgery.