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Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain (SENZA-PDN)

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ClinicalTrials.gov Identifier: NCT03228420
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Nevro Corp

Brief Summary:
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Device: Senza HF10 Therapy Other: CMM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HF10 therapy plus CMM
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Device: Senza HF10 Therapy
Senza 10kHz Spinal Cord Stimulation

CMM Alone
Conventional Medical Management
Other: CMM
Conventional Medical Management




Primary Outcome Measures :
  1. Composite of safety and effectiveness [ Time Frame: 3 months ]
    Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).


Secondary Outcome Measures :
  1. Pain scores of 3 or less [ Time Frame: 3 months ]
    Difference between the treatment groups in proportion of subjects with a lower limb pain VAS score ≤ 3 cm.

  2. Crossover rates [ Time Frame: 6 months ]
    Difference between the treatment groups in crossover rates. Subjects who meet pre-specified criteria may elect to crossover to the other treatment arm at 6-month follow-up.

  3. Responder rates [ Time Frame: 6 months ]
    Difference between the treatment groups in responder rates. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).

  4. Remitter rates [ Time Frame: 6 months ]
    Difference between the treatment groups in the proportion of remitters (remission is defined as having a lower limb pain VAS score of ≤ 3.0 cm for at least 6 months).

  5. Neurological assessment [ Time Frame: 3 months ]
    Difference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).

  6. Neurological assessment [ Time Frame: 6 months ]
    Difference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).

  7. Health-related quality of life [ Time Frame: 6 months ]
    Difference between the treatment groups in changes in health-related quality of life as assessed by the EuroQol Five Dimensions questionnaire (EQ-5D-5L).

  8. Hemoglobin A1c [ Time Frame: 6 months ]
    Difference between the treatment groups in the average percentage change from baseline in HbA1c levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
  2. Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
  3. Have stable neurological status.
  4. Be on a stable analgesic regimen.
  5. Be 22 years of age or older at the time of enrollment.
  6. Be an appropriate candidate for the surgical procedures required in this study.
  7. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
  8. Be willing and capable of giving informed consent.
  9. Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

Exclusion Criteria:

  1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
  2. Have a BMI ≥ 40.
  3. Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
  4. Have a medical condition or pain in other area(s), not intended to be treated in this study.
  5. Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.
  6. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
  7. Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
  8. Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
  9. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
  10. Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
  11. Have an existing drug pump and/or another active implantable device such as a pacemaker.
  12. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guidelines in the Physician's Manual.
  13. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
  14. Have a life expectancy of less than one year.
  15. Have a local infection at the anticipated surgical entry site or an active systemic infection.
  16. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
  17. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
  18. Be concomitantly participating in another clinical study.
  19. Be involved in an injury claim under current litigation.
  20. Be a recipient of Social Security Disability Insurance (SSDI).
  21. Have a pending or approved worker's compensation claim.
  22. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228420


Locations
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United States, Florida
Coastal Orthopedics
Bradenton, Florida, United States, 34209
United States, Georgia
Georgia Pain Care
Stockbridge, Georgia, United States, 30281
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Wisconsin
Advanced Pain Management
Greenfield, Wisconsin, United States, 53221
Sponsors and Collaborators
Nevro Corp
Investigators
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Study Director: David Caraway, MD Nevro Corp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nevro Corp
ClinicalTrials.gov Identifier: NCT03228420    
Other Study ID Numbers: CA2016-5
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases