SENZA-RCT: A first-of-its-kind study1
The first multicenter, prospective, randomized, controlled pivotal study of an SCS system.
First randomized, pivotal study of an SCS system
- Largest RCT study for back pain and leg pain: 241 participants enrolled, 198 randomized, 171 implanted
First study to directly compare SCS technologies
- HF10™ therapy compared to traditional SCS
First RCT study to enroll patients with BOTH back pain and leg pain
- Inclusion criteria required VAS of ≥5 for BOTH back pain and leg pain
First SCS study to report on 100% of patients to 12 months
- 171 implanted patients followed to 12 months
The most rigorous study in SCS history1,2
Rigorous design
- Designed in consultation with and monitored by the FDA
- Study design provided an independent control (traditional SCS)
- Pain relief, responder rates, and functional outcomes tracked and reported at 3, 6, 12, 18 and 24 months.
Rigorous execution
- Each company had full access to patients and supported programming of their respective SCS system
- 100% of subjects accounted for through 12 months
SENZA-RCT study design2
Key patient eligibility criteria1
Demographics and characteristics1
BOTH CONTROL AND TEST GROUPS ARE WELL MATCHED DUE TO RANDOMIZATION
| Characteristics |
| Gender - n (%) |
| Female |
| Male |
| Age (years) at enrollment |
| Mean ± SD |
| Range |
| Year Since Diagnosis |
| Mean ± SD |
| Range |
| Previous Back Surgery - n (%) |
| Baseline of Opioids - n (%) |