Neuropathic Pain Clinical Trial
— Modulate-LBPOfficial title:
Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)
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 plus usual care (control) and followed up to 6 months.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | August 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adults over the age of 18 2. Onset of low back pain > 12 months 3. Low back pain intensity > 60 out of 100mm on pain visual analogue scale (VAS) 4. 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) 5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography 6. 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 7. Legally able to provide informed consent 8. Able to comply with study-related requirements, procedures and visits Exclusion Criteria: 1. Had previous spinal surgery 2. Chronic widespread pain 3. Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.) 4. 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 5. 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 6. 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 7. Bleeding diathesis such as coagulopathy or thrombocytopenia 8. Immunocompromised and at an increased risk for infection 9. Systemic infection or local infection that would contraindicate SCS placement 10. Metastatic malignant disease or active local malignant disease 11. 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) 12. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication. 13. 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 14. Concomitant participation in another clinical trial (surgery, device or drug) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas Hospital | London | |
United Kingdom | South Tees Hospitals NHS Foundation Trust | Middlesbrough |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust | King's College London, National Institute for Health Research, United Kingdom, Pain And Neuromodulation Academic Research Centre (PANARC), The James Cook University Hospital, Middlesbrough, University of Exeter, University of Liverpool, University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean VAS Back Pain (7 Day Subject VAS Pain Diary) | Changes in mean VAS back pain between intervention and control at 6 months post-randomisation | 6 months post randomisation | |
Secondary | Oswestry disability index (v2.1a) | To compare disability between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | PHQ-9 Questionnaire | To compare depression between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | PSQI Questionnaire | To compare sleep quality between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | PGIC Questionnaire | To compare patients' global impression of change between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | EQ-5D Questionnaire | To compare health-related quality of life between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | Medication Usage | To compare medication usage between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | Sensation Map | To compare sensation maps between intervention and control at 1, 3, and 6 months post-randomisation. | 1, 3, and 6 months post randomisation | |
Secondary | Healthcare utilisation, work status, work absence, and out of pocket expenses | To compare the cost-effectiveness of 10kHz-SCS between intervention and control at six months post-randomisation. | 6 months post randomisation | |
Secondary | Safety/Adverse Events | To compare complications and adverse events at 6-months post-randomisation between intervention and control. | 6 months post randomisation |
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