NEUROMODULATION
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A DISTINCTLY DIFFERENT WAY
TO TREAT CHRONIC LOW BACK PAIN

Low back pain is the world’s leading cause of years lost to disability.1 Often, there is not a specific anatomical cause that can be treated with spine surgery.

Neurostimulation is a well-established pain treatment used by doctors for more than 50 years. One of Abbott’s most advanced forms of this therapy is BurstDR™ stimulation. It works by using mild electrical pulses delivered by a small implant to change pain signals as they travel from the spinal cord to the brain.2

The DISTINCT study is designed to understand how BurstDR stimulation can relieve pain and improve physical function in people with chronic low back pain who have not had back surgery and in people who are not good candidates for surgery.

When you participate in a clinical trial, you are joining the front line against a disease. If you have suffered with low back pain for more than 6 months and have been told you are not a candidate for spine surgery, ask your doctor if the DISTINCT study is right for you.

PRE-SCREENING QUESTIONS

DISTINCT will evaluate the efficacy of spinal cord stimulation to relieve pain and improve physical function in people with chronic low back pain who have not had back surgery and for whom other treatments, such as medication, physical therapy and injections, have failed.  This study will randomize participants to either conventional medical management or spinal cord stimulation for 6 months. After 6 months, participants may cross over to the treatment arm of the study.

In order to qualify for the study, your answers to the following must be YES:*

  1. I have chronic (at least 6 months) low back pain and have been told that I am not a candidate for spine surgery.
  2. I have tried multiple therapies in the past 6 months that have not adequately helped me.
  3. I have not had surgery for my back pain or pain that shoots down my leg.
  4. On a scale from 0=no pain to 10=worst pain, my back pain is at least a 6.
  5. My back pain is the main problem. I may have some leg pain, but it is not as bad as my back pain.
  6. I do not have fibromyalgia or widespread pain (all over my body).

And your answers to all of the following must be NO:*  

  1. My back pain is due to a tumor, infection or damage to my spinal cord
  2. I have severe scoliosis
  3. I have tried other neuromodulation devices
  4. I have or have had an implantable drug pump
  5. My BMI is >40
  6. I am receiving worker’s compensation or am in litigation
  7. I have a known allergic reaction to implanted materials
  8. I have a neurological deficit (e.g. foot drop)

LOCATE A CLINICAL STUDY SITE NEAR YOU
Postal Code
Or use your location

 


 

COMING SOON**

 
Axis Spine
Jameson, Jessica
7600 N Mineral Drive, Suite #450
Coeur D'Alene, Idaho, 83815, United States
 
Banner Univ Medical Center
Ibrahim, Mohab
1501 N Campbell Ave
Tucson, Arizona, 85724, United States
 
Brigham and Womens
Gilligan, Chris
75 Frances Street
Boston, Massachusetts, 02115, United States
 
Burkhart Research Institute for Orthopaedics
Duncan, Jonathan
400 Concord Plaza Drive
San Antonio, Texas, 78216, United States
 
Fullerton Orthopaedic Surgery
Lee, David
680 Langsdorf Drive, Suite #103
Fullerton, California, 92831, United States
 
Mayo Clinic
Moeschler, Susan
200 1st St. SW
Rochester, Minnesota, 55905, United States
 
Montefiore Medical Center
Wahezi, Sayed
1250 Waters Place, Tower #2
Bronx, New York, 10461, United States
 
Northshore University Health System
Dickerson, David
2650 Ridge Avenue
Evanston, Illinois, 60201, United States
 
 
OrthoNeuro
Chen, Ying
5040 Forest Drive, Suite #300
Columbus, Ohio, 43054, United States
 
Rhode Island Hospital
Scarfo, Keith
593 Eddy Street
Providence, Rhode Island, 02903, United States
 
University Hospitals Cleveland Medical Center
Sweet, Jennifer
11100 Euclid Ave
Cleveland, Ohio, 44106, United States
 
University of California at San Francisco
Jacques, Line
500 Parnassus Avenue, MU 436 East Tower
San Francisco, California, 94143, United States
 
Kansas University
Braun, Ted
3901 Rainbow Blvd
Kansas City , Kansas, 66160, United States
 
University of Virginia Medical Center
Hassanzadeh, Hamid
1215 Lee Street
Charlottesville, Virginia, 22908, United States
 
Spanish Hills Interventional Pain
Buchanan, Patrick
1100 Paseo Camarillo     
Camarillo, California, 93010, United States
 
The Cleveland Clinic Foundation
Bolash, Robert
9500 Euclid Avenue
Cleveland, Ohio, 44195, United States
 

 

 

References

*There may be additional inclusion/exclusion criteria which will be assessed via screening before enrollment in the study
**Sites have not yet completed activation process

1. Buchbinder R, van Tulder M, Öberg B, et al. Low back pain: a call for action. Lancet. 2018;391(10137):2384-2388.
2. De Ridder, D., Vanneste, S., Plazier, M., & Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude Medical’s Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices, 12(2), 143–150 

Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

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