N/A Completed N=15 Randomized Other

Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

Back Pain · Postoperative Pain

Source: ClinicalTrials.gov NCT03756012 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2021

Primary outcomePrimary: Effect of Pulse Widths on Pain Clinical Outcomes — 15; 0 Participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Effect of Pulse Widths on Pain Clinical Outcomes	15; 0	—
SECONDARY Change in Targeted Pain	15; 0	—
SECONDARY Distribution of Paesthesia	15; 0	—
SECONDARY Research Participant Program Preference	9; 6	—
SECONDARY Quality of Pain Relief	6; 5; 4; 0; 0	—
SECONDARY Research Participant Pain Relief Satisfaction	12; 3; 0; 0; 0	—
SECONDARY ≥ 50% Pain Relief	15; 0	—
SECONDARY Rate of AEs	—	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03756012). 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. Informational only — not medical advice.