Burst Spinal Cord Stimulation for Neuropathic Pain.

A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.

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.

Study Overview

• Status: Completed
• Conditions: Lower Back Pain; Radiculopathy; Peripheral Neuropathic Pain
• Intervention / Treatment: Device: Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital, Department of Pain Management and Research
• Sweden
  • Uppsala, Sweden
    • Uppsala University Hospital, Multidisciplinary Pain Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Burst SCS; 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.	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
Sham Comparator: Sham; In the sham comparator the burst SCS system will be turned off according to randomisation.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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: 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: 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: 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	The Patient-Specific Functional Scale (Numeric Rating Scale (0-10)) (day 7-13). Anchor points 0 = Unable to perform activity to 10 = Able to perform activity.	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)
Insomnia	Insomnia Severity Index questionnaire. (Likert scale: 0= no problem, 4 = very severe problem, total score up to 28. Total score (continuous variable)	Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D index values	EQ5D index values according to the EQ-5D UK Time Trade-off (TTO) value set.	Time Frame: Will be measured at the end of each 14-day treatment period
EQ-5D self-rated health	VAS 0-100 scale.	Time Frame: Will be measured at the end of each 14-day treatment period
Patient impression of change	Patient Global Impression of Change questionnaire. Patient's global impression of change (function, symptoms and quality of life) since last control (about 14 days prior): Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.	Time Frame: Will be measured at the end of each 14-day treatment period
Patient blinding questionnaire	Does the patient think that the system has been turned on or off	Time Frame: Will be measured at the end of each 14-day treatment period
Synptoms of anxiety and depression	Hopkins Symptom Checklist-25. Likert scale, from 1(Not at all) to 4 (Extremely), mean of sumscore, 25 in total. Change in totalscore (Continious variable).	Time Frame: Will be measured at the end of each 14-day treatment period
Usual pain intensity in lower back	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.	Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Uppsala University Hospital
• Investigators: Principal Investigator: Bård Lundeland, PhD, Department of Pain Management and Research, Oslo University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 22, 2023

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Neuralgia; Radiculopathy
• Other Study ID Numbers: 2017/402/REK nord

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who fulfill institutional guidelines.
• IPD Sharing Time Frame: All of the individual participant data collected during the trial will be available after deidentification, beginning 9 months and lasting 5 years after publication.
• IPD Sharing Access Criteria: Applications must fulfill institutional guidelines and requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No