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:*
- I have chronic (at least 6 months) low back pain and have been told that I am not a candidate for spine surgery.
- I have tried multiple therapies in the past 6 months that have not adequately helped me.
- I have not had surgery for my back pain or pain that shoots down my leg.
- On a scale from 0=no pain to 10=worst pain, my back pain is at least a 6.
- My back pain is the main problem. I may have some leg pain, but it is not as bad as my back pain.
- I do not have fibromyalgia or widespread pain (all over my body).
And your answers to all of the following must be NO:*
- My back pain is due to a tumor, infection or damage to my spinal cord
- I have severe scoliosis
- I have tried other neuromodulation devices
- I have or have had an implantable drug pump
- My BMI is >40
- I am receiving worker’s compensation or am in litigation
- I have a known allergic reaction to implanted materials
- I have a neurological deficit (e.g. foot drop)