NCT Number: NCT03733886
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Oslo University Hospital, Department of Pain Management and Research, Oslo, Norway
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Absolute
Relative
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
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); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
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); highest pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Time Frame: Will be measured at the end of each 14-day treatment period
VAS 0-100 scale.
Time frame: 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.
Time frame: 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
Time frame: 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).
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); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
Oslo University Hospital
Other
A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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