Algovita Spinal Cord Stimulation System Hi-Fi Study

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03622866
• Other study ID #: CLRE 1092
• Status: Terminated
• Phase: N/A
• Start date: November 2, 2018
• Est. completion date: April 27, 2020

Study information

• Verified date: March 2021
• Source: Nuvectra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Ultra-high pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components
• Traditional pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Chestnut Hill	Massachusetts
United States	Adena Spine Center	Chillicothe	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Spinal Diagnostics & Pain Management	Colorado Springs	Colorado
United States	Newport Beach Headache & Pain	Newport Beach	California
United States	Mid-America PolyClinic & Interventional Pain Management Specialists	Overland Park	Kansas
United States	Comprehensive Spine Center at Rhode Island Hospital	Providence	Rhode Island
United States	Summit Pain Alliance	Santa Rosa	California
United States	WK River Cities Clinical Research Center	Shreveport	Louisiana
United States	Pain Institute of Southern Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Nuvectra	Bright Research Partners

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of targeted pain reduction compared to baseline in each treatment arm	The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.; Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.	Week 25
Primary	Rate of serious study-related adverse events (AEs) in each treatment arm	The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.	From Permanent Implant through Week 25
Secondary	Effectiveness of targeted pain reduction compared to baseline in each treatment arm	The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.	Week 12 and Months 12, 18 and 24
Secondary	Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm	The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm	The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Change in targeted, back and/or leg pain compared to baseline in each treatment arm	The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Change in targeted, back and/or leg pain compared to baseline in each treatment arm	The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Clinician Global Impression of Change score in each treatment arm	The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Change in disability compared to baseline in each treatment arm	The change from baseline in disability as measured by the Oswestry Disability Index. The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Change in quality of life compared to baseline in each treatment arm	The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Change in patient activity per the Pain Disability Index score in each treatment arm	The change from baseline in patient activity as measured by the Pain Disability Index score. The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Patient Global Impression of Change score in each treatment arm	The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Participant satisfaction per the subject satisfaction survey outcome in each treatment arm	Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.	Weeks 12 and 25, and Months 12, 18 and 24
Secondary	Evaluation of trial success rates	The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.	From Trial Implant to End of Trail
Secondary	Rate of surgical re-intervention of the SCS system	Rate of surgical re-intervention of the SCS system for participants with a permanent implant.	From Permanent Implant through Month 24