Burst Spinal Cord Stimulation for Neuropathic Pain.

NCT03733886 | Completed

• 1 other identifier: 2017/402/REK nord
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

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.

Conditions

Peripheral Neuropathic Pain; Radiculopathy; Lower Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Highest pain intensity in lower extremity(ies)

  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)

  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"

  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

  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

  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)

Study Arms (2)

Burst SCS

ACTIVE COMPARATOR

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)

Sham

SHAM COMPARATOR

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)

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

Burst SCS; Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Uppsala University Hospital: collaborator

Study Sites (2)

Oslo University Hospital, Department of Pain Management and Research

Oslo, Norway

Location

Uppsala University Hospital, Multidisciplinary Pain Center

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Radiculopathy; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bård Lundeland, PhD

  Department of Pain Management and Research, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: September 9, 2019
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.
• Access Criteria: Applications must fulfill institutional guidelines and requestors will need to sign a data access agreement.

Locations

NO (1); SE (1)