NCT03526055

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

Completed NA Results posted Last updated 21 February 2019

What this trial tests

NA trial testing Algovita Spinal Cord Stimulation System in Spinal Cord Stimulation in 10 participants. Completed in 31 May 2018.

Timeline

26 February 2018

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Amol Soin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	10
Start date	26 February 2018
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	1 location across United States

Drugs / interventions tested

• Algovita Spinal Cord Stimulation System

Conditions studied

• Spinal Cord Stimulation — all drugs for Spinal Cord Stimulation →
• Pain, Back — all drugs for Pain, Back →
• Pain — all drugs for Pain →

Sponsor

Amol Soin

Who can join

18 and older, any sex, with Spinal Cord Stimulation or Pain, Back. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subject Pain Relief Primary · up to 8 days

The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.

Group	Value	95% CI
<500 µS Pulse Width	56	0 – 100
>1000 µS Pulse Width	61	30 – 90

Subject Preference Secondary · Up to 8 days

Subjects will be asked to select their favorite program

Group	Value	95% CI
<500 µS Pulse Width	4
>1000 µS Pulse Width	7

Achievement of ≥50% Pain Relief Secondary · Up to 8 days

Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale.

Group	Value	95% CI
<500 µS Pulse Width	5
>1000 µS Pulse Width	8

Rate of AEs Secondary · From spinal cord stimulation implant through study completion or study exit, Up to 8 days

Rate of device-related and/or procedure-related AEs

Group	Value	95% CI
Entire Study Population	0

Sponsor's own description

The purpose of this study is to evaluate the effect of pulse widths \<500 µS and \>1000 µS on clinical outcomes during a temporary SCS trial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.