Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Intractable Pain; Chronic Leg Pain; Low Back Pain; Chronic Low-back Pain; Leg Pain

• Registration Number: NCT07190807
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).

In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24
• Primary Completion: 2027-11
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.
• Diagnosed with chronic pain of the trunk and/or limbs for at least 6 months.
• 18 years of age or older when written informed consent is obtained
• Able to independently read and complete all questionnaires and assessments provided in English.
• Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.

Key

Exclusion Criteria

• Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).
• Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
• A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
• Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Targeted Pain Responder Rate	3 months post-activation	Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation