Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS

Summary

Aim of the study Failed back surgery syndrome (FBSS) is a clinical entity consisting of chronic leg and /or back pain due to radicular nerve damage. The effectiveness of Spinal Cord Stimulation (SCS) in the pain management of patients with FBSS is proven. Patients mostly have dominant leg pain, however a significant percentage of FBSS patients has a more pronounced back pain and are commonly excluded from SCS as it is often inadequate in relieving both the back and leg pain components. Recently some reports showed the benefit of subcutaneous stimulation (SubQ) for low back pain in patients with FBSS. This has been confirmed by a feasibility study performed by our group. The aim of the randomized controlled study is to evaluate the effect of SubQ on low back pain in FBSS patients for whom SCS gives an inadequate back pain relief.

Hypothesis We hypothesize that SubQ in addition to SCS in FBSS patients with leg and low back pain is more effective in treating low back pain (i.e. \>50% pain reduction) than SCS alone.

Conditions

• Low Back Pain
• Failed Back Surgery Syndrome
• Neuropathic Pain

Interventions

DEVICE

SubQ

Spinal Cord Stimulation (SCS) and subcutaneous (SubQ) stimulation SCS trial stimulation: Implantation of the Octad lead in the epidural space. The lead implantation in the epidural space is performed under local anesthesia using a standard percutaneous technique. A key element to the technical success of an SCS procedure is the accurate placement of the lead, which results in paresthesia covering the patients' painful areas. This depends on the patients' feedback during intra-operative testing. Therefore, it is important that the patient is awake and fully cooperative during the trial stimulation.

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Rijnland Hospital

  collaborator OTHER

• Medtronic

  collaborator INDUSTRY

• Sint Maartenskliniek

  collaborator OTHER

• Diakonessenhuis locatie Zeist

  collaborator UNKNOWN

• SubQ

  lead OTHER

Principal Investigators

• Kris CP Vissers, MD,PhD,FIPP · Radboud University Medical Center

• Eric-Jan JA van Gorp, MD · Albert Schweitzer Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-09

Primary Completion

2014-12-20

Completion

2015-07-11

Countries

• Netherlands

Study Locations