Clinical trial NCT03733886: Burst Spinal Cord Stimulation for Neuropathic Pain.
Official title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathic Pain
Radiculopathy
Lower Back Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2018-11-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: N-of-1-study.

Each patient will go through three treatment cycles each consisting of two weeks of active treatment and two weeks of sham in randomised order. In total the study period will be 12 weeks.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Usual pain intensity in lower extremity(ies)
timeFrame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Secondary outcomes:
measure: Highest pain intensity in lower extremity(ies)
timeFrame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
measure: Lowest pain intensity in lower extremity(ies)
timeFrame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
measure: Pain intensity in lower extremity(ies)"now"
timeFrame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
measure: Pain unpleasantness
timeFrame: Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
measure: Three individually chosen functions that are inhibited by the pain
timeFrame: 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)
measure: Insomnia
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: EQ-5D index values
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: EQ-5D self-rated health
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: Patient impression of change
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: Patient blinding questionnaire
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: Synptoms of anxiety and depression
timeFrame: Time Frame: Will be measured at the end of each 14-day treatment period
measure: Usual pain intensity in lower back
timeFrame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Pain Management and Research
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Multidisciplinary Pain Center
Study officials:
affiliation: Department of Pain Management and Research, Oslo University Hospital
name: Bård Lundeland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.