NCT01486108

Brief Summary

Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

7 months

First QC Date

September 21, 2011

Last Update Submit

December 2, 2011

Conditions

Neuropathic Pain

Keywords

tonic, burst and placebo stimulation

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scales for pain back, pain limb, pain general and paresthesia

Secondary Outcomes (1)

  • VAS scores for pain now, worst pain, least pain and pain vigilance and awareness questionnaire

Study Arms (3)

Tonic

EXPERIMENTAL

5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)

Procedure: dorsal column stimulator

Sham

EXPERIMENTAL

no stimulation, patient receive a sham stimulation (actually the IPG is not running)

Procedure: dorsal column stimulator

burst

EXPERIMENTAL

500 hz burst at 5 hz stimulation

Procedure: dorsal column stimulator

Interventions

dorsal column stimulatorPROCEDURE

test different settings of stimulation

Also known as: IPG is used by ST Jude medical together with an 88 lamitrode lead
ShamTonicburst

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients able to provide informed consent to participate in the study;
  • Patient is between the age of 18 and 75;
  • Patient has Failed Back Surgery Syndrome;
  • Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
  • Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
  • Patient agrees not to add or increase medication throughout the randomization trial period of the study;
  • Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.

You may not qualify if:

  • A patient will be excluded from participation in this study if they meet any one of the following criteria:
  • Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
  • Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
  • Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
  • Patient currently participating in another clinical study;
  • Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
  • Patient is not willing to maintain current medication regimen;
  • Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, 2650, Belgium

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: 34854473DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sven Vanneste, PhD

    Universiteit Antwerpen

    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
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 21, 2011

First Posted

December 6, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

BE(1)