Trials / Unknown
UnknownNCT03680846
Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Nevro Corp · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HF10 Therapy | Senza 10 kHz Spinal Cord Stimulation |
| OTHER | CMM | Conventional Medical Management |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2020-10-06
- Completion
- 2022-11-01
- First posted
- 2018-09-21
- Last updated
- 2021-10-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03680846. Inclusion in this directory is not an endorsement.