Burst Spinal Cord Stimulation for Neuropathic Pain.

Oslo University Hospital10 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Peripheral Neuropathic Pain Radiculopathy Lower Back Pain

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Oslo University Hospital, Department of Pain Management and Research

Oslo, Norway

Uppsala University Hospital, Multidisciplinary Pain Center

Uppsala, Sweden

Outcomes

Primary Outcomes

Usual pain intensity in lower extremity(ies)

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)

Secondary Outcomes

Highest pain intensity in lower extremity(ies)

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: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)

Lowest pain intensity in lower extremity(ies)

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)

Pain intensity in lower extremity(ies)"now"

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)

Pain unpleasantness

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 period (to avoid carry-over effects from previous treatment period)

Three individually chosen functions that are inhibited by the pain

Data from ClinicalTrials.gov

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