Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain

NCT03228420 | Unknown Results FDA Device

• 1 other identifier: CA2016-5
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 4

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.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Composite of Safety and Effectiveness

  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 Outcomes (8)

• Pain Scores of 3 or Less

  3 months

• Crossover Rates

  6 months

• Responder Rates

  6 months

• Remitter Rates

  6 months

• Neurological Assessment

  3 months

Study Arms (2)

HF10 therapy plus CMM

ACTIVE COMPARATOR

The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management

Device: Senza HF10 Therapy

CMM Alone

OTHER

Conventional Medical Management

Other: CMM

Interventions

Senza HF10 Therapy DEVICE

Senza 10kHz Spinal Cord Stimulation

HF10 therapy plus CMM

CMM OTHER

Conventional Medical Management

CMM Alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (4)

Coastal Orthopedics

Bradenton, Florida, 34209, United States

Location

Georgia Pain Care

Stockbridge, Georgia, 30281, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Advanced Pain Management

Greenfield, Wisconsin, 53221, United States

Location

Related Publications (9)

• Klonoff DC, Levy BL, Jaasma MJ, Bharara M, Edgar DR, Nasr C, Caraway DL, Petersen EA, Armstrong DG. Treatment of Painful Diabetic Neuropathy with 10 kHz Spinal Cord Stimulation: Long-Term Improvements in Hemoglobin A1c, Weight, and Sleep Accompany Pain Relief for People with Type 2 Diabetes. J Pain Res. 2024 Sep 18;17:3063-3074. doi: 10.2147/JPR.S463383. eCollection 2024.

  PMID: 39308991 DERIVED

• Argoff CE, Armstrong DG, Kagan ZB, Jaasma MJ, Bharara M, Bradley K, Caraway DL, Petersen EA; for Investigators. Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation. J Diabetes Sci Technol. 2025 Jul;19(4):992-998. doi: 10.1177/19322968231222271. Epub 2024 Jan 9.

  PMID: 38193426 DERIVED

• Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Brooks ES, Edgar DR, 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. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract. 2023 Sep;203:110865. doi: 10.1016/j.diabres.2023.110865. Epub 2023 Aug 1.

  PMID: 37536514 DERIVED

• 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.

  PMID: 35814185 DERIVED

• Armstrong DG, Grunberger G. Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy. J Diabetes Sci Technol. 2023 Sep;17(5):1387-1391. doi: 10.1177/19322968221099542. Epub 2022 Jun 30.

  PMID: 35770993 DERIVED

• 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(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

• 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.

  PMID: 34844993 DERIVED

• 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.

  PMID: 33818600 DERIVED

• 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.

  PMID: 31941531 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Donald Middlebrook
• Organization: Nevro Corp.

don.middlebrook@nevro.com

(650) 433-2218

Study Officials

• David Caraway, MD

  Nevro Corp

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 24, 2017
• Study Start: July 20, 2017
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2022
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Locations

US (4)