Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedtronicNeuro
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:
* SCS group (SCS+OMM)
* OMM group
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
SCS candidate with the Specify 5-6-5 surgical lead
Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
Average low back pain is ≥ 5 as assessed by the baseline NPRS
Average low back pain is greater than leg pain
Subject has persistent moderate to severe low back and leg pain despite other treatments
You may not be if
Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
Most recent back surgery \< 6 months ago
Low back pain only (no leg pain)
Investigator suspects substance abuse that might confound the study results
Radiographic evidence of instability requiring fusion
Pain relieved completely by lying down
Life expectancy of \< 24 months
Subject is pregnant or planning to become pregnant during the course of the study
Subject is unable to undergo study assessments or complete questionnaires independently
Clareo Health | Spinal Cord Stimulation for Predominant Low Back Pain
