Status:
COMPLETED
High Frequency (1000Hz) Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Neuropathic Pain
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Spinal Cord stimulation (SCS) is a common intervention used in patients who suffer from chronic nerve pain following back surgery. This is known as failed back surgery syndrome (FBSS). Equally, the Na...
Detailed Description
Spinal cord stimulation (SCS) is a successful treatment in patients with intractable neuropathic pain. This therapy is most commonly used in patients who have chronic neuropathic pain following failed...
Eligibility Criteria
Inclusion
- Age 18-70
- Chronic Back Pain (≥ 6 mo) with NRS ≥ 6/10
- Back pain predominant over leg pain (if leg pain present)
- Failure to respond to conventional treatment including intense rehababilitation and facet/MBB/SI interventions
- No prior spinal surgery for the back and leg pain on the same site of implantation.
- Presence of lumbar degenerative disc disease
- Absence of spinal pathology which would require surgical intervention
- Stable dose of opioids and anti-neuropathic drugs for ≥ 6 months
- Patients with intractable lumbar neuropathic pain who are due to receive Percutaneous Spinal Cord Stimulation as part of their standard treatment per NICE HTA guidance 159 at Barts Health NHS Hospitals.
- Patients who have given their written informed consent.
- Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.
- Patients must be able to communicate in English in order to complete validated questionnaires written in English.
Exclusion
- Patients not able to comply or understand the study-related requirements
- Active alcohol, recreational or prescription drug abuse in the last 3 months.
- Unwilling to reduce excessive pain medications
- A medical/psychiatric condition that could interfere with study procedures, accurate pain reporting, and/or confound study outcomes
- Patients with diabetes or any current diagnosis of progressive neurological disease (i.e., CIDP, Multiple sclerosis)
- Immuno-compromised/high risk for surgical infection
- Pregnant and/or breast feeding
- Terminal illness with anticipated survival \< 12 months
- Patients who have been part of a previous spinal cord stimulation trial
- Currently implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- Untreated clinically significant sleep disorder as judged by the CI.
- Unresolved issues of secondary gain (i.e., litigation)
- Participation in another clinical study in the last 30 days that would confound data.
Key Trial Info
Start Date :
October 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03818074
Start Date
October 9 2018
End Date
July 7 2024
Last Update
November 5 2024
Active Locations (1)
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1
Vivek Health Mehta
London, United Kingdom, EC1A 4NP