Chronic neuropathic pain in patients with an incomplete or complete spinal cord injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients will be referred to the study from the spinal injuries unit at the centre. If they fullfil the entry criteria and would like to participate, they will be given all information to allow for in
Sponsors
South Tees Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A spinal cord injury (complete or incomplete lesion) of at least 2 years 2. Injury at T12/L1 or above 3. A disability grade on the American Spinal Injury Association (ASIA) Impairment Scale (AIS) of A, B, C or D as determined by a qualified examiner 4. Neuropathic pain as determined clinically by the investigator at or below the level of the SCI 5. Average pain intensity for the target pain area of > = 5 out of 10 cm on the Visual Analogue Scale (VAS) at enrollment when the patient is taking medication 6. Stable chronic pain for at least 4 weeks 7. Refractoriness to pain treatment as determined by the Investigator (which can include medication and/or other treatment modalities) 8. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit 9. An appropriate candidate for EVOKE™ Spinal Cord Stimulation implant as determined by the Investigator 10. An appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician and if applicable per the local regulations 11. An adult (> = 18 years of age) at the time of enrolment 12. Willing and capable of giving written informed consent prior to any investigational related procedure (if not able to write consent will happen through legal or personal representative) 13. Willing and able to comply with study-related requirements, assessments and visits These decisions are based on the clinical judgement of the investigator.
Exclusion criteria
Exclusion criteria: 1. 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 in consultation with a clinical psychologist 2. A current diagnosis of a progressive neurological disease such as multiple sclerosis, inflammatory, infective, vascular, demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis 3. An invalid AIS (e.g. ASIA motor exam not obtainable) 4. A current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator. 5. A diagnosis that precludes lead placement (e.g. severe scoliosis, presence of metalwork) 6. Radiographic evidence of spinal instability requiring fusion as determined by the Investigator 7. Previous and/or current experience with drug pump and/or neurostimulator or another active implantable device such as a pacemaker 8. Metastatic malignant disease or active local malignant disease 9. A life expectancy of less than 1 year 10. An active systemic or local infection 11. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) 12. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 13. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat the targeted pain area 14. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study Decisions will be based on the clinical judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using the visual analogue score (VAS) at baseline, end of the trial, at 1, 3 and 6 months, and any unscheduled visits. It will also be collected in a pain diary four times per day during the trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impairment due to spinal injury measured using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) at baseline, 3 and 6 months 2. Neurological pain measured using the Douleur-Neuropathique-4 (DN-4) questionnaire at baseline, end of trial assessment, 3 and 6 months 3. Spasticity measured using the Modified Ashworth Scale and the Penn Spasm Frequency Scale at baseline, end of trial assessment, 3 and 6 months 4. Disability measured using the Spinal Cord Independence Measure (SCIM) at baseline, end of trial assessment, 3 and 6 months 5. Health status measured using the European Quality of Life-5 Dimensions - EQ-5D-5L at baseline, end of trial assessment, 3 and 6 months 6. Change from Baseline in the general state of health measured using the Patient Global Impression of Change instrument (PGIC) at 6 months 7. Change from Baseline in the general state of health measured using the Clinician* Global Impression of Change instrument (CGIC) at 6 months; *Clinician: both pain physician and SCI specialist to complete 8. Depression measured using the Beck Depression Inventory II at 6 months 9. Sleep disturbance measured using the Pain and Sleep Questionnaire three-item Index (PSQ-3) at baseline, end of trial assessment, 3 and 6 months 10. Medication use measured at every visit 11. Assessment of subject's satisfaction with therapy (assessed by a Subject Satisfaction Questionnaire) at 6 months using 7 point Likert scale | — |
Countries
United Kingdom
Contacts
Public ContactAnu Kansal
Outcome results
None listed