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A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.

NCT03201705 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-10-03

No results posted yet for this study

Summary

Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain. The waves used in Spinal Cord Stimulation are mainly Tonic or Burst. Both Tonic and Burst stimulation offer neuropathic pain suppression, with slightly superiority of the Burst wave for the FBSS. The aim of our study is to evaluate the efficacy of a new stimulation paradigm with the combination of the two wave forms.

Conditions

  • Failed Back Surgery Syndrome

Interventions

DEVICE

Burst + Tonic

Patients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant (Precision Spectra system, Boston Scientific). Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference.

Sponsors & Collaborators

  • Massimo Innamorato

    lead OTHER

Principal Investigators

  • Massimo Innamorato, MD · Ospedale Santa Maria delle Croci

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-12-30
Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201705 on ClinicalTrials.gov