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Procedure

Stimulation On for Neuropathic Pain (SPARK Trial)

N/A

Waitlist Available

Led By Lutz Weise, MD, PhD

Research Sponsored by Nova Scotia Health Authority

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of post intra-thoracic surgery pain syndrome

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at 4, 10, 16, 26, and 52 weeks post-surgery

Awards & highlights

SPARK Trial Summary

This trial will test if spinal cord stimulation is effective in treating pain in patients who have had thoracic surgery.

What is being tested?

This study is looking at how well spinal cord stimulation helps with pain after chest surgery. It's a controlled trial where patients are randomly chosen to receive either the real treatment or a placebo, and then they switch.See study design

SPARK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have pain after chest surgery.

SPARK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 4, 10, 16, 26, and 52 weeks post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at 4, 10, 16, 26, and 52 weeks post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 4, 10, 16, 26, and 52 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline on the Numerical Rating Scale (NRS) for pain intensity

Secondary outcome measures

Change in morphine equivalents used

Change in score on EuroQol 5 Dimension Questionnaire

Change in score on Oswestry Disability Index

+2 more

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT03284411

10%

Device stimulation issue

Inadequate analgesia

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Spinal Cord Stimulation

SPARK Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Stimulation OnExperimental Treatment1 Intervention

Spinal cord stimulators will be optimized to each participant and then programmed to deliver high frequency stimulation below detectable threshold for 6 weeks.

Group II: Stimulation OffPlacebo Group1 Intervention

Spinal cord stimulators will be optimized to each participant as in the experimental arm, and then programmed to deliver no stimulation for 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal Cord Stimulation

2020

Completed Phase 4

~90

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor

260 Previous Clinical Trials

83,898 Total Patients Enrolled

1 Trials studying Neuropathic Pain

12 Patients Enrolled for Neuropathic Pain

Lutz Weise, MD, PhDPrincipal InvestigatorNova Scotia Health Authority

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"Per the information provided on clinicaltrials.gov, this specific research study is not presently seeking new participants. The trial was first published on June 1st, 2024 and underwent its most recent update on April 25th, 2024. Although recruitment has ceased for this particular trial, it's worth noting that there are currently 602 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain

Lutz Weise 2024. "Spinal Cord Stimulation Pioneering Analgesia for Resilient Recovery in Post Intra-Thoracic Surgery Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06390150.

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