CompletedNot Applicable

CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

United Kingdom60 participantsStarted 2016-11

Plain-language summary

The study will compare therapeutic efficacy of a novel spinal cord stimulation leads implant based on anatomical landmarks with standard surgical implantation technique.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is able to provide informed consent to participate in the study; * Subject is 18 years of age or older; * Subject has failed to respond to at least 6 months of conventional treatment including pharmacological treatment, physical therapy, epidural injections and/or radiofrequency therapy as per NICE Tag 0159; * FBSS subjects with predominant low back pain; * Subject has a lower back pain intensity of at least 6.0 out of 10.0 on the VAS at baseline; * Subject is on stable pain medications with a total opioid equivalent of 120 mgs a day or less for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device; * Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system; * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; * Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study Exclusion Criteria: * Subjects with significant scoliosis even if surgically corrected * Subject is currently participating in a clinical investigation that incl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS) for Back Pain at SCS Trial

Timeframe: after 2 weeks of SCS trial

Trial details

NCT IDNCT02986074

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-19

Results submitted2020-03-03

View on ClinicalTrials.gov More Chronic Pain trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.