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

NCT03201705 | Unknown

• 1 other identifier: TONIC+BURST
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Failed Back Surgery Syndrome; Spinal Cord Stimulation; Pain Management; Implantable Neurostimulator

Outcome Measures

Primary Outcomes (1)

• Change in Pain Suppression

  Pain suppression by "Tonic" and "Burst+Tonic" waves Spinal Cord Stimulation, in relation at measure previous of implant, expressed with Numerical Rate Scale (NRS)

  Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

Secondary Outcomes (10)

• Change in quality of Life

  Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

• Change in energy use of the battery

  15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

• Change in halving the pain

  15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

• Change in use of rescue medication

  Baseline (pre intervention), 15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

• Change in number of stimulation adjustments

  15 days and 30 days of Tonic Stimulation, 15 days and 30 days of Combined Stimulation

Study Arms (1)

Refractory neuropathic leg and low back pain

EXPERIMENTAL

Patients with refractory neuropathic leg and low back pain as result of FBSS will be enrolled in the study and receive electrocatheter implant. 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.

Device: Burst + Tonic

Interventions

Burst + Tonic DEVICE

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.

Refractory neuropathic leg and low back pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic, persistent, refractory, low back pain as a result of spinal surgery
• Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain
• Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months
• Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area
• Subject is able and willing to provide informed consent
• Subject is able and willing to comply with the protocol and follow-up schedule

You may not qualify if:

• Back pain component of more than 20% or VAS \> 40mm on 100mm scale
• Bilateral limb pain
• Subjects with a previous SCS implantation
• Changes in pain medication in the 2 months preceding the trial period
• Expected inability of subjects to correctly operate the neurostimulation system
• Presence of any other clinically significant or disabling chronic pain condition (eg. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc.)
• History of coagulation disorders, lupus erythematosus, diabetes mellitus
• Symptoms or proof of any malignant disease
• Current use of medicines affecting coagulation which cannot be temporarily stopped
• Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
• Life expectancy of less than 1 year
• Existing or planned pregnancy in the trial period

Sponsors & Collaborators

• Massimo Innamorato: lead

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Massimo Innamorato, MD

  Ospedale Santa Maria delle Croci

  STUDY DIRECTOR

Central Study Contacts

Massimo Innamorato, MD

CONTACT

00393386789153; massimo.innamorato@auslromagna.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 28, 2017
• Study Start: December 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 3, 2017

Record last verified: 2017-10