A Study to Compare HF10 Therapy Combined with Conventional Medical Management (CMM) to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-000601
NCT ID: NCT03680846
Sponsor Protocol Number: CA2018-2 US NSRBP
About this study
The purpose of this study is to document the safety, clinical effectiveness and cost-effectiveness of high-frequency 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery.
- Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain.
- Qualifying pain score.
- Be on stable pain medications, as determined by the Investigator.
- Be willing and capable of giving informed consent.
- Be willing and able to comply with study-related requirements, procedures and visits.
- Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent
Exclusion Criteria:
- Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders.
- Have a medical condition or pain in other area(s), not intended to be treated in this study.
- Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator.
- Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain.
- Have any addictions as determined by the Investigator.
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker.
- Have prior experience with neuromodulation devices.
- Other general exclusions applicable for SCS devices.
- Be involved in an injury claim under current litigation.
- Have a pending or approved worker's compensation claim.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Markus Bendel, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available