N/A N=10 Randomized Other

Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

Spinal Cord Stimulation · Pain, Back · Pain

Bottom Line

View on ClinicalTrials.gov: NCT03526055 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Subject Pain Relief — 56; 61 percentage of pain relief

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Algovita Spinal Cord Stimulation System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amol Soin
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Subject Pain Relief	56; 61	—
SECONDARY Distribution of Paresthesia	—	—
SECONDARY Subject Preference	4; 7	—
SECONDARY Quality of Pain Relief	—	—
SECONDARY Subject Satisfaction	—	—
SECONDARY Achievement of ≥50% Pain Relief	5; 8	—
SECONDARY Rate of AEs	—	—

Summary

The purpose of this study is to evaluate the effect of pulse widths 1000 µS on clinical outcomes during a temporary SCS trial.

Eligibility Criteria

Inclusion Criteria

Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
Study candidate is undergoing a SCS trial using Nuvectra Algostim system
Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
Subject is 18 years of age or older when written informed consent is obtained

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03526055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.