Comparison of HF10 therapy combined with Conventional Medical Managment (CMM) to CMM alone in the treatment of chronic back pai

Recruiting

• Conditions: Chronic non-surgical refractory back pain; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN87648175
• Lead Sponsor: evro Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 11 February 2019
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component
2. Have failed conventional medical treatments
3. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
4. Demonstrating multi-level Degenerative Disc Disease and no current indication for referral for back surgery
5. Considering daily activity and rest, have average back pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
6. Average back pain intensity greater than average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
7. Be on stable pain medications, as determined by the Investigator
8. Be 18 years of age or older at the time of enrollment
9. Be willing and capable of giving informed consent
10. Be willing and able to comply with study-related requirements, procedures, and visits
11. 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

1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Have significant clinically mechanical spine instability
5. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
6. Have an opioid addiction or drug seeking behavior as determined by the Investigator
7. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
8. Have prior experience with neuromodulation devices
9. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guideline in the Physician’s Manual
10. Have metastatic malignant disease or active local malignant disease
11. Have a life expectancy of less than 2 years
12. Have an active systemic or local infection
13. Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control)
14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
15. Be concomitantly participating in another clinical study
16. Be involved in an injury claim under current litigation
17. Have a pending or approved worker’s compensation claim

Study & Design

• Study Type: Interventional
• Study Design: Not specified