This trial is evaluating whether Phase 2; Low Dose MYOBLOC will improve 2 primary outcomes and 15 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline and Week 4.
This trial requires 272 total participants across 10 different treatment groups
This trial involves 10 different treatments. Phase 2; Low Dose MYOBLOC is the primary treatment being studied. Participants will be divided into 6 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.
Most patients who suffer a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) have multiple causes. While these causes are difficult to find, it is important for patients and their families to have high-quality information regarding prevention and treatments as well as an understanding of risk factors associated with spinal cord injuries.
Although SCI does not affect the basic functions of the human body, the ability to perceive pain disappears in individuals with SCI. Pain perception fades over time in patients with brain-injured individuals, especially with the loss of touch perception in the extremities. Many patients who are in a vegetative state do not perceive pain due to the absence of other sensory nerves from the spinal cord. However, the ability persists and patients perceive pain. Therefore, to prevent and reduce pain, we need to make great efforts to learn about pain perception and to use it to relieve it. Spinal anesthesia is used to alleviate pain in patients with severe neuromuscular disorders.
A person who sustains a [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) is often a victim of trauma, where the body's bones were fractured and shattered, or of the pressure of a speeding car. The damage to the spinal cord can often result in mobility loss, and loss of sensation in parts of the body below the level of the point of injury. Most spinal cord injuries come about as a result of a car crash, while the number of spinal cord injuries from assault and unintentional falls are on the rise.\n
Sufficient evidence exists to suggest that treatment for spinal cord injury is highly dependent upon the cause and location of the injury. Medication is often used to treat many forms of spinal cord injury, with the intention to reduce pain and spasticity. This is particularly relevant to patients with penetrating trauma or spinal cord injury where immobilization of the spine is necessary. A range of medications and interventions are used for the management of other forms of spinal cord injury. Treatment includes physical therapy, occupational therapists, Speech Language Therapy, and specialized equipment like the L-tube and a wheelchair. Severe cases (such as trauma in the cervical region) are treated to minimize neurological deficits in order to maximize functional recovery and overall independence.
The US experiences a considerable number of spinal cord injuries (SCI), with the annual number of people affected estimated to be over 200,000. SCI results from falling, lifting, road traffic, etc., are often the result of a crash, accident, or a natural event. Prevention programs and medical education efforts should focus on preventing people engaging in dangerous behaviors associated with falls and lifting activities from falling, and educating individuals about the risks of such incidents.
There is evidence that myobloc is well accepted and safe in patients with [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury). Although this is only a phase 2 trial, there are a few side effects of myobloc. They include pain, bruising, and local or general adverse reactions. Myobloc should be used carefully for patients with spinal cord injuries.
Using a combination of MTX, a myobloc® and a baclofen pump, a high dose of MTX has been shown to be more effective than a placebo in reducing spasticity in a patient diagnosed with spinal cord injury. If long term, baclofen pumps may be a better option than a baclofen pump which is more complicated to use and more expensive.
It is imperative that we all gain a better understanding of the many variables in determining outcomes for SCI patients. Many things are unknown about the effect of the time of injury, environment, and type of injury on patient outcomes. It is important to look at this information to determine what interventions need to be put in place when possible. Currently, there are still unanswered questions about the underlying pathomechanisms involved in SCI which makes recovery from injury difficult. To reduce mortality and morbidity resulting from SCI, we must continue to look at the many possible factors surrounding the injury that affect the outcomes of each individual. Data from a recent study from clinical trials and other meta-analyses are crucial for us to look at and must be interpreted on an individual basis.
The average age of injury for patients who are admitted to a rehabilitation unit is 59 years of age. In contrast, for patients in the hospital, the average is 47 years old. This difference illustrates a more complicated course of treatment for those who suffer spinal cord injuries. Clinicians should keep these factors in mind when assessing patients' potential for recovery.
[SCI can be a devastating and life-crunching injury that can lead to severe disability. Furthermore, SCI is extremely rare and the number of injured patients is small so the treatment is highly complicated and the outcome is extremely difficult] (Habib et al., Spinal Cord injuries: basic and advanced concepts, 2nd ed., 2014, Elsevier Publishing Group Inc., pp. 10–14).
The likelihood of acquiring a SCI is not linked to the presence or absence of a prior affected family member. The authors discuss the importance of considering the genetic basis of susceptibility to SCI when planning prevention strategies.