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.
In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.
Brief Title
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Central Contacts
Central Contact Role
Contact
Central Contact Phone
855-213-9890
Central Contact Email
BSNClinicalTrials@bsci.com
Central Contact Role
Contact
Central Contact Phone
855-213-9890
Central Contact Email
BSNClinicalTrials@bsci.com
Completion Date
Completion Date Type
Estimated
Conditions
Chronic Pain
Intractable Pain
Low Back Pain
Chronic Low-back Pain
Chronic Leg Pain
Leg Pain
Eligibility Criteria
Key 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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Spinal Cord Stimulation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07190807
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
A4116
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)
Primary Outcomes
Outcome Description
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Outcome Measure
Targeted Pain Responder Rate
Outcome Time Frame
3 months post-activation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sayed Wahezi
Investigator Email
swahezi@montefiore.org
Investigator Department
Physical Medicine & Rehabilitation
Investigator Division
Pediatric Physical Medicine and Rehabilitation
Investigator Sponsor Organization
External
Study Department
Please Specify
Study Division
Please Specify
Categories Mesh Debug
Substance Use and Addiction --- CHRONIC PAIN
Brain, Spinal Cord & Nervous System --- LOW BACK PAIN
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- BACK PAIN
MeSH Terms
CHRONIC PAIN
PAIN, INTRACTABLE
LOW BACK PAIN
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
BACK PAIN