Trials / Completed
CompletedNCT03733886
Burst Spinal Cord Stimulation for Neuropathic Pain.
A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Burst 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 |
Timeline
- Start date
- 2019-09-09
- Primary completion
- 2023-06-22
- Completion
- 2023-06-22
- First posted
- 2018-11-07
- Last updated
- 2023-08-30
Locations
2 sites across 2 countries: Norway, Sweden
Source: ClinicalTrials.gov record NCT03733886. Inclusion in this directory is not an endorsement.