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ReActiv8 Neurostimulation for Chronic Lower Back Pain (ReActiv8-B Trial)
ReActiv8-B Trial Summary
This trial is to see if ReActiv8 is a safe and effective treatment for adults with chronic low back pain when used with medical management.
ReActiv8-B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowReActiv8-B Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ReActiv8-B Trial Design
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Who is running the clinical trial?
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- I experience a certain level of pain.My back pain is caused by issues with my blood vessels.I need back surgery according to guidelines or cannot have it for other reasons.I am between 22 and 75 years old.I am scheduled for surgery.I have a long-term pain condition.The doctor has confirmed that the pain is coming from the sacroiliac joint.There are signs that the muscles in your lower back are not working properly.Use of drugsI have had lower back pain for more than 90 days.My back pain is caused by conditions like endometriosis, fibroids, or infections.My pain level qualifies for the study.I have had chronic low back pain for more than 90 days.I have symptoms like foot drop related to my back pain.You have signs of problems with the muscles in your lower back.I have a narrow spinal canal in my lower back causing leg pain.I have had surgery for scoliosis or currently have scoliosis.My MRI shows a clear cause for my chronic lower back pain that can be fixed with surgery.I have had a lower back injury that can be treated with surgery.I have had low back pain for over 90 days despite treatment.I have back pain because of spinal cord inflammation or damage.I have not had any recent surgeries or procedures.My leg pain is worse than my back pain, or I have nerve pain below the knee.My BMI is over 35.I am willing and able to give my consent for treatment.Any other medical conditionsExclusions based on mental and social factors.Disability level meets the required score.I have had low back pain for over 90 days despite treatment.My doctor has approved me for ReActiv8 surgery.
- Group 1: Treatment
- Group 2: Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the geographical scope of this clinical research?
"Upstate Clinical Trials in Spartanburg, South carolina, Duke University Medical Center in Durham, North carolina and the University of California San Diego in La Jolla are amongst 17 sites that are accepting patients for this clinical trial."
What criteria must be met to qualify for participation in this experiment?
"Prospective participants in this clinical trial must have low back pain and be aged between 22-75. A total of 204 patients are being enrolled for the study."
What are the expected results of this experiment?
"The goal of this clinical trial, assessed over 120 days, is to analyse the cumulative proportion of responders for its primary endpoint. Secondary outcomes include a comparison on the European Quality Of Life Score On Five Dimensions (EQ-5D) and Subject Global Impression Of Change (SGIC), both at one year post-treatment. Additionally, Mean Change In Low Back pain Visual Analog Scale (VAS) will be measured after 12 months as well. After day 120, participants in the control group can have their device programmed to deliver appropriate stimulation levels before being reassessed one year later. An improved score would signify an improvement from baseline values whilst"
Is there an age restriction for participants in this investigation?
"This research is only open to individuals between the ages of 22 and 75."
Are there any recruitment opportunities for patient participation in this experiment?
"According to clinicaltrials.gov, this research study is not presently enrolling patients, having been first posted on August 1st 2016 and last updated January 4th 2022. Nevertheless, 337 other trials are currently recruiting participants."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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