- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228420
Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain (SENZA-PDN)
July 17, 2021 updated by: Nevro Corp
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
430
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Bradenton, Florida, United States, 34209
- Coastal Orthopedics
-
-
Georgia
-
Stockbridge, Georgia, United States, 30281
- Georgia Pain Care
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Wisconsin
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Greenfield, Wisconsin, United States, 53221
- Advanced Pain Management
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
- Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
- Have stable neurological status.
- Be on a stable analgesic regimen.
- Be 22 years of age or older at the time of enrollment.
- Be an appropriate candidate for the surgical procedures required in this study.
- 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.
- Be willing and capable of giving informed consent.
- Be willing and able to comply with study-related requirements, procedures, and scheduled visits.
Exclusion Criteria:
- 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.
- Have a BMI ≥ 40.
- Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
- Have a medical condition or pain in other area(s), not intended to be treated in this study.
- 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.
- 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.
- Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
- Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
- Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
- Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
- Have an existing drug pump and/or another active implantable device such as a pacemaker.
- 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.
- Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
- Have a life expectancy of less than one year.
- Have a local infection at the anticipated surgical entry site or an active systemic infection.
- 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.
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- Be concomitantly participating in another clinical study.
- Be involved in an injury claim under current litigation.
- Be a recipient of Social Security Disability Insurance (SSDI).
- Have a pending or approved worker's compensation claim.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: HF10 therapy plus CMM
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
|
Senza 10kHz Spinal Cord Stimulation
|
Other: CMM Alone
Conventional Medical Management
|
Conventional Medical Management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
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.
|
6 months
|
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).
|
6 months
|
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).
|
6 months
|
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).
|
3 months
|
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).
|
6 months
|
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).
|
6 months
|
Hemoglobin A1c
Time Frame: 6 months
|
Difference between the treatment groups in the average percentage change from baseline in HbA1c levels.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Caraway, MD, NEVRO Corp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12:CD013756. doi: 10.1002/14651858.CD013756.pub2. Review.
- Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Jul 1;6(4):347-360. doi: 10.1016/j.mayocpiqo.2022.05.003. eCollection 2022 Aug.
- Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022 Jan 1;45(1):e3-e6. doi: 10.2337/dc21-1813. No abstract available.
- Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
- Mekhail NA, Argoff CE, Taylor RS, Nasr C, Caraway DL, Gliner BE, Subbaroyan J, Brooks ES. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020 Jan 15;21(1):87. doi: 10.1186/s13063-019-4007-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2017
Primary Completion (Actual)
May 1, 2020
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
July 20, 2017
First Posted (Actual)
July 24, 2017
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
July 17, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA2016-5
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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