Status:
TERMINATED
Sham-Controlled RCT on 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
Pain And Neuromodulation Academic Research Centre (PANARC)
University of Exeter
Conditions:
Chronic Low Back Pain
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS...
Detailed Description
The prevalence of chronic low back pain in the population is estimated to range between at 12% and 28% (1-4). Within this group an estimated 12-15% of adults suffer from chronic neuropathic lower back...
Eligibility Criteria
Inclusion
- Adults over the age of 18
- Onset of low back pain \> 12 months
- Low back pain intensity \> 60 out of 100mm on pain visual analogue scale (VAS)
- Presence of clear component of neuropathic pain based on a PainDETECT Questionnaire score of \>19 (we will monitor this inclusion criteria in the early stage of the trial and revise if necessary)
- Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
- On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
- Legally able to provide informed consent
- Able to comply with study-related requirements, procedures and visits
Exclusion
- Had previous spinal surgery
- Chronic widespread pain
- Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.)
- A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis
- Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by \>5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
- A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- Bleeding diathesis such as coagulopathy or thrombocytopenia
- Immunocompromised and at an increased risk for infection
- Systemic infection or local infection that would contraindicate SCS placement
- Metastatic malignant disease or active local malignant disease
- Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal)
- Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
- Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
- Concomitant participation in another clinical trial (surgery, device or drug)
Key Trial Info
Start Date :
August 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03470766
Start Date
August 14 2018
End Date
October 20 2022
Last Update
June 12 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Guy's and St Thomas Hospital
London, United Kingdom, SE1 7EH
2
South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom, TS4 3BW