A Study to Compare HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

Overview

About this study

The purpose of this study is 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.

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:

  • Patients with chronic, refractory*, primary axial back pain who based on consultation with a spine surgeon or neurosurgeon:
    • Are not candidates for or are not eligible for major lumbar spine surgery (such as fusion, microdiscectomy, laminectomy, arthroplasty, etc.); or
    • Present with spinal conditions for which surgery is typically indicated**, but must not be considered eligible for surgery due to lack of severity, lack of clearly identifiable structural cause, lack of desire to undergo major lumbar surgery, or other factors.
  • Pain should have a predominant neuropathic component as per the investigator’s clinical assessment.
  • Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain.
  • Considering daily activity and rest, have average back pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
  • Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to assessing pain intensity as described in inclusion criterion #4 above.
  • Be 18 years of age or older at the time of enrollment.
  • 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.
  • Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.
    • *Pain is defined as refractory, regardless of etiology, when conventional medical management has failed to reach treatment goals that may include adequate pain reduction and/or improvement in daily functioning or have resulted in intolerable adverse effects. 
    • **Degenerative disc disease, neurogenic claudication, radiculopathy, progressive motor or neurological loss, severe degenerative scoliosis, spondylosis disc herniation, spinal or foraminal stenosis, spinal instability, spondylolisthesis, pseudo-arthrosis, or other conditions.

Exclusion Criteria:

 

  • Have a diagnosed back condition with inflammatory causes of back pain (e.g., ankylosing spondylitis or diseases of the viscera).
  • Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
  • Have evidence of an active disruptive psychological or psychiatric disorder identified as the primary condition or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by the investigator in consultation with a psychologist.
  • Have a current diagnosis of a progressive neurological disease, spinal cord tumor, or severe/critical spinal stenosis.
  • Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus that would add unacceptable risk to the procedure.
  • Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain.
  • Have an opioid addiction or drug seeking behavior 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 (SCS, PNS, DRG, multifidus muscle stimulation).
  • 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.
  • Have metastatic malignant disease or active local malignant disease.
  • Have a life expectancy of less than 1 years.
  • Have an active systemic or local infection.
  • Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
  • 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).
  • Be concomitantly participating in another clinical study.
  • 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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Naresh Patel, M.D.

Open for enrollment

Contact information:

Erica Boyd R.N., CCRP

(480) 342-1316

Boyd.Erica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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