Burst Spinal Cord Stimulation for Neuropathic Pain.
- Conditions
- RadiculopathyLower Back PainPeripheral Neuropathic Pain
- Interventions
- Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
- Registration Number
- NCT03733886
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
- Detailed Description
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.
Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.
In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
- Understand Norwegian or Swedish language (written and spoken).
- Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)
Absolute
- Opioid dose > 100 mg morphine equivalents / day
- Ongoing litigation
- Mental / psychiatric disorder that may affect treatment
- Chronic generalized pain
- Pregnancy
- Hypersensitivity to local anesthetics
- Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
- Laminectomy in or above level for planned epidural access
- Spine surgery the last 3 months
Relative
- Ongoing medication that affects coagulation or platelet function
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Burst SCS Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) In the active comparator the burst SCS system will be turned on according to randomisation. A treatment period is a 2-week period where the patient receives either active treatment or sham. Each patient will go through 6 treatment periods (in total 12 weeks). A treatment cycle is a 4-week period with two treatment periods, one of active treatment and one of sham. Each patient will go through three treatment cycles. Sham Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10) In the sham comparator the burst SCS system will be turned off according to randomisation.
- Primary Outcome Measures
Name Time Method Usual pain intensity in lower extremity(ies) Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
- Secondary Outcome Measures
Name Time Method Insomnia Time Frame: Will be measured at the end of each 14-day treatment period Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)
EQ-5D index values Time Frame: Will be measured at the end of each 14-day treatment period EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.
EQ-5D self-rated health Time Frame: Will be measured at the end of each 14-day treatment period VAS 0-100 scale.
Three individually chosen functions that are inhibited by the pain Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period) The Patient-Specific Functional Scale (Numeric Rating Scale (0-10)) (day 7-13). Anchor points 0 = Unable to perform activity to 10 = Able to perform activity.
Patient impression of change Time Frame: Will be measured at the end of each 14-day treatment period Patient Global Impression of Change questionnaire. Patient's global impression of change (function, symptoms and quality of life) since last control (about 14 days prior): Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Pain intensity in lower extremity(ies)"now" Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10); evening pain intensity (day 7-13), with anchor points 0 = No pain and 10 = Worst imaginable pain
Synptoms of anxiety and depression Time Frame: Will be measured at the end of each 14-day treatment period Hopkins Symptom Checklist-25. Likert scale, from 1(Not at all) to 4 (Extremely), mean of sumscore, 25 in total. Change in totalscore (Continious variable).
Patient blinding questionnaire Time Frame: Will be measured at the end of each 14-day treatment period Does the patient think that the system has been turned on or off
Highest pain intensity in lower extremity(ies) Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10); highest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain
Lowest pain intensity in lower extremity(ies) Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10); lowest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain
Pain unpleasantness Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10) of pain unpleasantness the last 24 hours, with anchor points 0 = no unpleasantness to 10 = worst imaginable unpleasantness.
Usual pain intensity in lower back Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period) Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
Trial Locations
- Locations (2)
Uppsala University Hospital, Multidisciplinary Pain Center
🇸🇪Uppsala, Sweden
Oslo University Hospital, Department of Pain Management and Research
🇳🇴Oslo, Norway