Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

Terminated

• Conditions: Chronic Pain

• Registration Number: NCT02373540
• Lead Sponsor: Nuvectra

Brief Summary

The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Study Start: 2015-06
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
• Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial
• Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required

Exclusion Criteria

• Patient is contraindicated for an Algovita SCS system
• Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
• Patient has a life expectancy of less than 2 years
• Patient is participating in another clinical study that would confound data analysis
• Patient has a coexisting pain condition that might confound pain ratings

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent reduction in targeted pain compared to baseline	6 Month Follow-up Visit	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.

Secondary Outcome Measures

Name	Time	Method
Rate of device-related and/or procedure-related Adverse Events (AEs)	From Implant through 24 Month Follow-up Visit	To record the rate of device-related and/or procedure-related Adverse Events (AEs).
Change in quality of life compared to baseline	1, 3, 6, 12, 18, and 24 Month Follow-up Visits	Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status.
Percent reduction in targeted pain compared to baseline	1, 3, 12, 18, and 24 Month Follow-up Visits	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.
Percent change in targeted pain intensity compared to baseline	1, 3, 6, 12, 18, and 24 Month Follow-up Visits	Percent reduction or actual reduction from baseline in targeted pain intensity, 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.
Rate of surgical intervention of the SCS system	From Implant through 24 Month Follow-up Visit	To record the rate of surgical intervention of the SCS system.
Change in disability compared to baseline	1, 3, 6, 12, 18, and 24 Month Follow-up Visits	Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
Willingness to undergo procedure again	1, 3, 6, 12, 18, and 24 Month Follow-up Visits	To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again.

Trial Locations

Locations (18)

Summit Healthcare Pain Clinic Associates; 🇺🇸 Show Low, Arizona, United States

Coastal Pain and Spinal Diagnostics; 🇺🇸 Carlsbad, California, United States

Samaritan Center for Medical Research; 🇺🇸 Los Gatos, California, United States

Restore Orthopedics and Spine Center; 🇺🇸 Orange, California, United States

Vitamed Research; 🇺🇸 Rancho Mirage, California, United States

Spine & Nerve Diagnostic Center; 🇺🇸 Roseville, California, United States

Relieve Pain Center; 🇺🇸 San Diego, California, United States

Nona Medical Arts; 🇺🇸 Orlando, Florida, United States

South Florida Clinical Research; 🇺🇸 South Miami, Florida, United States

Ephraim McDowell Regional Medical Center; 🇺🇸 Danville, Kentucky, United States

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