Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
Not provided
Not provided
Not provided
This study is a prospective, multi-center study designed to compare the safety and efficacy of spinal cord induced muscle stimulation (MuscleSCS) for the treatment of chronic low back pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MuscleSCS | Device | The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (>50% pain relief). Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG. |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | Numerical Rating Scale for Pain | Enrollment to End of Study (3mo Visit) |
| ODI | Oswestry Disability Index | Enrollment to End of Study (3mo Visit) |
| EQ5D-5L | 5 Dimension Health Related Quality of Life Questionnaire | Enrollment to End of Study (3mo Visit) |
| PDI | Pain Disability Index | Enrollment to End of Study (3mo Visit) |
| PCS | Pain Catastrophizing Scale | Enrollment to End of Study (3mo Visit) |
| PGIC | Patient Global Impression of Change | Enrollment to End of Study (3mo Visit) |
Not provided
Not provided
Inclusion Criteria:
Patients with PSPS type 1 and 2
Patients with predominant back pain
Patient must be willing and able to provide written informed consent before any clinical investigation-related procedure
Age ≥18 y
Patients with SCS(BurstDR) stimulation in situ for more than 6 month and >50% pain relief. Patients have to be satisfied with their existing SCS therapy and predominantly use a BurstDR stimulation program.
(Only responders to that therapy should be included, not patients who have not responded to their therapy so far.) [GROUP 1]
Low back pain baseline score of ≥6 on NRS before spinal cord stimulation therapy and a MCID (Minimal clinically important difference) of >50% with SCS(BurstDRTM) trial stimulation. [GROUP 2]
Willing and able to comply with the instructions for use, operate the study device, and comply with this clinical investigation plan
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Young, RN, BSN, DMPNA | Contact | 304-347-6144 | amelia.young3@wvumedicine.org |
| Name | Affiliation | Role |
|---|---|---|
| Timothy R Deer, MD | WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVUM/Thomas Hospitals (Saint Francis Hospital) Spine and Nerve Center | Recruiting | Charleston | West Virginia | 25301 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The population for this study will include two specific groups of the same pain population. Group one is the Pre-existing SCS Group, these are pain patients with chronic back pain, and who have been implanted with an SCS system with a percutaneous lead or a paddle lead and BurstDRTM IPG for more than 6 month and having success with their BurstSCS stimulation (>50% pain relief).
Group two is the Trial SCS Group, these are pain patients with chronic back pain, and who have been determined to be candidates for trial and potential permanent SCS with a percutaneous lead or a paddle lead and BurstDRTM IPG.
Not provided
Not provided
Not provided
Not provided