Clinical trial NCT03622866: Algovita Spinal Cord Stimulation System Hi-Fi Study
Official title: Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Nuvectra
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2018-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
* Age 18-75 years old at consent.
* Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
* ODI score of 41-80 out of 100 at the Baseline visit.
* Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
* On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
* Willing and capable of providing informed consent.
* Willing and able of complying with the study-related requirements, procedures, and visits.
* Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
* Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.

Exclusion Criteria:

* Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
* Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
* Has a condition currently requiring or likely to require the use of MRI or diathermy.
* Has an existing drug pump, SCS System, or other active implantable device.
* Has any prior SCS experience.
* Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
* For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
* Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
* Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.

Primary outcomes:
measure: Effectiveness of targeted pain reduction compared to baseline in each treatment arm
timeFrame: Week 25
measure: Rate of serious study-related adverse events (AEs) in each treatment arm
timeFrame: From Permanent Implant through Week 25
Secondary outcomes:
measure: Effectiveness of targeted pain reduction compared to baseline in each treatment arm
timeFrame: Week 12 and Months 12, 18 and 24
measure: Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Change in targeted, back and/or leg pain compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Change in targeted, back and/or leg pain compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Clinician Global Impression of Change score in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Change in disability compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Change in quality of life compared to baseline in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Change in patient activity per the Pain Disability Index score in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Patient Global Impression of Change score in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
timeFrame: Weeks 12 and 25, and Months 12, 18 and 24
measure: Evaluation of trial success rates
timeFrame: From Trial Implant to End of Trail
measure: Rate of surgical re-intervention of the SCS system
timeFrame: From Permanent Implant through Month 24
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pain Institute of Southern Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Newport Beach Headache & Pain
state: California
city: Santa Rosa
country: United States
facility: Summit Pain Alliance
state: California
city: Colorado Springs
country: United States
facility: Spinal Diagnostics & Pain Management
state: Colorado
city: Overland Park
country: United States
facility: Mid-America PolyClinic & Interventional Pain Management Specialists
state: Kansas
city: Shreveport
country: United States
facility: WK River Cities Clinical Research Center
state: Louisiana
city: Chestnut Hill
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Chillicothe
country: United States
facility: Adena Spine Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Providence
country: United States
facility: Comprehensive Spine Center at Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Nuvectra
name: Ben Tranchina
role: STUDY_DIRECTOR
References: