Peripheral Nerve Stimulation for Back

NCT04538430 | Terminated Results DMC FDA Device

• 1 other identifier: IRB 127414
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To assess changes in pain, physical function, health-related quality of life, and cost-effectiveness in patients with low back pain, without symptoms of radiculopathy, that have not responded to conservative or traditional interventional measures and are having a SPRINT percutaneous peripheral nerve stimulator placed as standard of care. Patients will be assessed periodically (by questionnaire) after the placement of the SPRINT, FDA approved 60 day, percutaneous peripheral nerve stimulator, targeting the bilateral medial branches at the suspected level of pain generation. Neither the manufacturer nor the FDA are involved or will have access to data from this study.

Conditions

Back Pain

Keywords

Axial Low Back Pain; Peripheral Nerve Stimulation; Medial Branches

Outcome Measures

Primary Outcomes (1)

• Pain Numeric Rating Scale (NRS) Response From SPRINT Percutaneous Peripheral Nerve Stimulator

  Assessment of Pain Numeric Rating Scale (0-10) response after placement of SPRINT percutaneous peripheral nerve stimulator for chronic low back pain. 0 being no pain and 10 being the worst pain.

  2 months

Study Arms (1)

Axial Low Back Pain

OTHER

Patient diagnosed with axial low back pain not responding to conservative measures and no symptoms of radiculopathy, that is scheduled to have a SPRINT percutaneous peripheral nerve stimulator placed as standard of care.

Device: SPRINT percutaneous peripheral nerve stimulator placed

Interventions

SPRINT percutaneous peripheral nerve stimulator placed DEVICE

Placement of a SPRINT percutaneous peripheral nerve stimulator targeting the bilateral medial branches at the suspected level of pain generation. This procedure is done as standard of care.

Axial Low Back Pain

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years of age at day of enrollment.
• Clinical diagnosis of refractory low back pain for \>3 months.
• Magnetic resonance imaging pathology consistent with clinical symptoms/signs at one or two levels.
• Back pain of at least 4/10 or higher using the Numerical Rating Scale (NRS).
• Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.

You may not qualify if:

• Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
• Contraindications to medial branch targeted PNS (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
• More than 2 levels of clinical proven pain.
• Active moderate to severe lumbar radiculopathy.
• Intradural disc herniation.
• Spinal fracture of posterior elements within the past 6 months.
• Steroid injection in the spine within the last 30 days.
• Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.
• Prior fusion at level considered to be the source of the pain.
• Prior lumbar spine surgery within the last 6 months.
• AP diameter of spinal canal less than or equal to 9mm at level to be treated.
• Severe uncontrolled medical condition.
• Severe psychological illness.
• History of Inflammatory arthritis.
• Malignancy within past 5 years except basal cell or squamous cell skin cancer.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Shellie Cunningham
• Organization: University of Utah

shellie.cunningham@hsc.utah.edu

801-587-5488

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 4, 2020
• Study Start: November 22, 2019
• Primary Completion: May 15, 2021
• Study Completion: September 9, 2021
• Last Updated: December 6, 2022
• Results First Posted: November 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)