Burst Spinal Cord Stimulation for Neuropathic Pain.

University of Oslo (UIO)

Status: Completed

Conditions: Lower Back Pain; Radiculopathy; Peripheral Neuropathic Pain

Treatments: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)

Study type: Interventional

Funder types: Other

Identifiers

NCT03733886

2017/402/REK nord

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups

Burst SCS

Active Comparator group

Description:

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.

Treatment:

Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)

Sham

Sham Comparator group

Description:

In the sham comparator the burst SCS system will be turned off according to randomisation.

Treatment:

Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)