Lower Back Pain, Peripheral Neuropathic Pain, Radiculopathy
Conditions
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).
Interventions
DEVICEBurst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold
Sponsors
Uppsala University Hospital
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
N-of-1-study. Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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. |
| 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. |
| 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) |
| 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 |
| EQ-5D self-rated health | Time Frame: Will be measured at the end of each 14-day treatment period | VAS 0-100 scale. |
| 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. |
| 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 |
| 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). |
| 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. |
| 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. |
Countries
Norway, Sweden
Outcome results
None listed