Sciatica (Lumbar Radiculopathy) Study

Sponsored by Seikagaku

Treatments

Here at RegeneSpine, we know how much pain can affect your life and relationships.

 

Are you suffering from SCIATICA, or LEG PAIN from a herniated disc?

Would you like to explore a nonsteroidal, non-opioid option other than surgery? Consider the Discovery 6603 Study!

What Will Study Participants be Asked to Do?

After informed consent where the risks, benefits, and alternatives are discussed, participants in this clinical research study will receive a single injection of the study drug (or a control injection). Involvement in the study will be about 12 months, during which participants will be asked to attend up to 11 study visits. You may be compensated for your time and travel.


Throughout the study, staff will monitor your health. They will collect blood and urine samples for laboratory testing. Participants will also receive an MRI and X-Ray. You will be asked questions about leg and back pain, medications being taken, and any side effects that you might have experienced. You will be provided with an electronic device on which you can record your pain condition and medication use on a daily basis. Participants will not be allowed to use opioids or cannabis during the study; other pain medications may be available if needed.

Herniated Discs and Leg Pain

Your lower back is made up of five lumbar vertebrae (bones) which surround and protect your spinal cord. Nerves travel along your spinal cord, sending information back and forth from your brain to other parts of your body. In between the vertebrae are flat, flexible discs that act as shock absorbers when you walk, run or jump. These discs have a flexible outer ring and a soft gel-like center.


When a disc’s gel-like center pushes through a weakened area of the disc it is called a herniated disc (or a slipped or ruptured disc). The gel may place pressure on the spinal cord or spinal nerves. This “pinches” the nerve and can lead to sciatica represented by the leg pain associated with herniated discs. A herniated disc happens most often in the lower back and is one of the most common causes of lower back and leg pain.

Herniated Discs and Leg Pain

Your lower back is made up of five lumbar vertebrae (bones) which surround and protect your spinal cord. Nerves travel along your spinal cord, sending information back and forth from your brain to other parts of your body. In between the vertebrae are flat, flexible discs that act as shock absorbers when you walk, run or jump. These discs have a flexible outer ring and a soft gel-like center.


When a disc’s gel-like center pushes through a weakened area of the disc it is called a herniated disc (or a slipped or ruptured disc). The gel may place pressure on the spinal cord or spinal nerves. This “pinches” the nerve and can lead to sciatica represented by the leg pain associated with herniated discs. A herniated disc happens most often in the lower back and is one of the most common causes of lower back and leg pain.

Who can take part?

You may be eligible to participate if you:

  • Are experiencing pain in a single leg that is associated with lumbar disc herniation which has not lasted for more than 12 months
  • Are 30 to 70 years of age
  • Are NOT receiving worker’s compensation
  • Can stop taking opioids/cannabis and remain o­ for the duration of the study
  • Have a body mass index (BMI) of less than 40

There are also other study requirements that will determine if you qualify. With your permission, these criteria will be reviewed by the study doctors and nurses when you contact or visit us.

Even if you consider receiving surgery for your herniated disc, you may be eligible for this study.

All study related exams and procedures are provided at no cost to you and you may be compensated for your time and travel.

About this clinical research study

About 320 people in the United States will take part in this clinical research study. The active study drug is administered as a single injection and is being compared with a control injection (an injection that contains no medication). One out of two participants will receive the active study drug.

Who can take part?

You may be eligible to participate if you:

  • Are experiencing leg pain associated with lumbar disc herniation, which emerged within the past 1 year
  • Are 30 to 70 years of age
  • Are not in routine use of opioids/cannabis
  • Are <35 of BMI
  • Are NOT receiving worker’s compensation, and
  • Are able to meet other entry criteria

If you qualify you will receive the investigational drug injection (or a control injection) at no charge to you.

  • Participation in the study is completely voluntary, and you may be compensated for your time.
  • Contacting us to learn more about the study does not obligate you to participate.