Oxycodone for Spinal Cord Injuries
This study is evaluating whether a placebo pill can help reduce the amount of pain medication needed for individuals with spinal cord injuries.
See full descriptionAbout the trial for Spinal Cord Injuries
Treatment Groups
This trial involves 2 different treatments. Oxycodone is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Oxycodone will improve 1 primary outcome and 6 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 days.
Who is running the study
Principal InvestigatorPatient Q & A Section
How many people get spinal cord injuries a year in the United States?
There are approximately 6500 cases of spinal cord injuries per year in the United States, making it the third most common traumatic injury. While this injury is most common in young adults with a peak incidence rate in those 18- to 29-year-old females, it also presents in all age groups. The average admission rate is 15.9 per 1,000. Most spinal cord injuries occur in motor vehicle accidents, accounting for more than 70% of cases. Patients who are admitted suffer from a median time to surgical intervention of around 24 hours, longer than that of patients who go directly to an emergency room.
What causes spinal cord injuries?
Traumatic spinal cord injuries can have different causes, including motor vehicle accidents. Spinal cord injuries are typically a result of an accident or fall, though accidents can affect babies too young to be awake for a fall - therefore impacting those with a younger age range.
What is spinal cord injuries?
Spinal cord injuries were found to be very common among the elderly, about 1 in 7,000 was found suffering from a spinal lesion. They accounted for a greater than 100,000-year-long life expectancy. Spermatic cord trauma was the most common type of traumatic injury. The incidence was low for cervical cord injuries and high for thoracic injuries. The mortality rate was higher for cervical injuries than thoracic injuries. Most spinal cord injuries occur in men, but the mortality rate is very high.
What are common treatments for spinal cord injuries?
Treatment for spinal cord injuries almost invariably involves [pain management](https://www.withpower.com/clinical-trials/pain-management) and immobilization or bracing. Most patients can expect to make a full recovery with medical care and occupational therapy. People who have spinal cord injuries and continue to have leg and/or arm pain often cannot receive adequate medical attention without a proper evaluation. Most need repeated exams and surgeries to repair spinal cord compression. The first important step in evaluation and treatment is to determine the level and type of injury and to pinpoint painful areas. Treatment requires that the surgeon and/or therapist work in close collaboration. Treatments include medical and surgical procedures such as manipulation, biopsies, decompression, implantation of epidural or facet screws, or microdiscectomy.
What are the signs of spinal cord injuries?
Spinal cord injuries typically cause bowel and bladder disturbances, loss of sensation, decreased motor function, and paralysis. Physicians can identify these changes using non-invasive measurements.
Can spinal cord injuries be cured?
All patients can regain and maintain the ability to walk. As a patient with a spinal cord injury reaches older age, care to prevent complications such as pressure sores, deconditioning, and urinary tract and pulmonary infections become increasingly difficult.
How does oxycodone work?
Oxycodone is a prodrug that rapidly decays to oxymorphone upon enzymatic action of esterases (FMO3 in the kidney and the CYP3A4 in the liver) in the intestines, with minimal first-order metabolism. FMO3 is also present in the blood-brain barrier and may therefore also absorb oxymorphone, which can be converted to (1S,(Z)-)-oxymorphone. The effect of oxymorphone on mu opioid receptors in the brain and spinal cord is different in the central (i.e., spinal cord) and autonomic nervous system, leading to unique analgesic effects and side effects.
What is the average age someone gets spinal cord injuries?
For people who are diagnosed with spinal cord injury, about 1 out of 3 of them were between the ages of 25-44, and about 1 out of 3 of them were between the ages of 15-24. This is consistent with the idea that younger persons are more likely to get a spinal injury in sports (e.g. soccer). Older persons tend to have an injury resulting from some other event, such as an automobile accident. This is known as a secondary injury. For example, if someone is hitting their head and has a vehicle in front of them, their spinal cord injury could be caused simply because they were already injured at the time of the vehicle crash.
What are the common side effects of oxycodone?
The most common side effects of oxycodone are dizziness, nausea, drowsiness, abnormal sleep patterns, sweating, dry mouth and constipation. The risk of experiencing side effects is greatly dependent on the dosage of oxycodone prescribed. People who are receiving care from a pain specialist, such as a rheumatologist, or who have a high probability of developing opioid tolerance can be at higher risk of experiencing side effects from the use of oxycodone. The risk of experiencing side effects also varies from person to person.
Who should consider clinical trials for spinal cord injuries?
Clinical trials could benefit SCI patients with some of the following criteria:\nThis survey has limitations inherent in its generalisability. It does not address the problem of lack of awareness among patients suffering from disabling neurological disorders due to lack of available data about this clinical domain. A questionnaire survey may nevertheless be a tool to measure patient's view on clinical trials. We need further work before being able to offer a clear recommendation about the need to conduct clinical trials in this group of patients.
What is the primary cause of spinal cord injuries?
The primary cause of spinal cord injuries may be a traumatic injury or an underlying disease such as polio. In some cases the exact cause cannot be determined. [A]nother [cause] may be an idiopathic (that is, of unknown cause) injury, such as an accidental injury. [Possible other causes] include spinal disc herniation, chronic infection, congenital defects such as muscular dystrophy, or cancer.
Is oxycodone typically used in combination with any other treatments?
Patients with a SCI treated with oxycodone alone generally experienced greater improvements with pain relief or function compared with treatment with any other opioid. Oxycodone treatment combined with other treatments was associated with improvement in pain relief and function.