Burst Spinal Cord Stimulation for Neuropathic Pain.

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    10
  • sponsor
    Oslo University Hospital
Updated on 25 February 2022
back pain
spinal cord
radiculopathy
peripheral neuropathic pain

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.

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).

Details
Condition Peripheral Neuropathic Pain, Radiculopathy, Lower Back Pain
Treatment Burst SCS, Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)
Clinical Study IdentifierNCT03733886
SponsorOslo University Hospital
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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
Relative
Spine surgery the last 3 months
Ongoing medication that affects coagulation or platelet function
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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