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Intrathecal Morphine Injection for Lower Back Pain in Spine Deformity Surgery
Study Summary
This trial will compare the effects of a pain management technique involving injecting morphine into the spinal cord versus traditional pain management strategies on post-operative recovery for patients who have undergone surgery to correct deformities.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Criterion: You have a fusion of at least 4 levels in your spine.You are 18 years old or older and have been diagnosed with adult or degenerative scoliosis.You have a fused L2-S1 spine that makes it hard to give you Duragesic through your lower back.You have had three or fewer spinal fusion surgeries.You have a neuromuscular disease.You need surgery to fix back or leg pain.You have severe health issues that make you at high risk for surgery.You cannot tolerate or are dependent on opioids.You have serious other health problems.
- Group 1: Control Group
- Group 2: Study Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA given its stamp of approval to Control Group?
"As this is a Phase 4 trial, and therefore approved for use, the safety of Control Group was rated 3 on our team's scale."
Has there been any exploration into the efficacy of Control Group in other research projects?
"At present, 54 medical trials are being conducted on Control Group with 15 of them in the advanced Phase 3. Boston is hosting the majority of these experiments while a total of 131 centres across the US are working on Control Group research."
Are there any available spots for participants in this clinical trial?
"Indeed, clinicaltrials.gov indicates that this trial is presently looking for participants; the first posting was on December 1st 2021 and the most recent update occurred on May 9th 2022."
What is the current enrollment rate for this experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently calling for applicants which was initially posted on December 1st 2021 and updated as recently as May 9th 2022. The research intends to enrol 40 participants across two different medical sites."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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