Burst Spinal Cord Stimulation for Neuropathic Pain.

NCT ID: NCT03733886

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2023-06-22

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).

Conditions

Peripheral Neuropathic Pain; Radiculopathy; Lower Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Sham

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

Group Type: SHAM_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bård Lundeland

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bård Lundeland, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pain Management and Research, Oslo University Hospital

Locations

Oslo University Hospital, Department of Pain Management and Research

Oslo, , Norway

Uppsala University Hospital, Multidisciplinary Pain Center

Uppsala, , Sweden

Countries

Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 34854473 (View on PubMed)

Other Identifiers

2017/402/REK nord

Identifier Type: -

Identifier Source: org_study_id