NCT02896361

Brief Summary

This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2016

Geographic Reach
2 countries

3 active sites

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

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 20, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

September 1, 2016

Results QC Date

August 3, 2018

Last Update Submit

May 17, 2019

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) for Pain

    Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain

    assessed every 2 weeks after each intervention, for a total of 6 weeks

Secondary Outcomes (4)

  • EQ-5D

    assessed every 2 weeks after each intervention, for a total of 6 weeks

  • Subject Preference

    assessed 6 weeks after baseline at the last follow up visit

  • Subject Satisfaction

    assessed every 2 weeks after each intervention, for a total of 6 weeks

  • Percentage of Participants With Adverse Events

    assessed over 6 weeks of study participation

Study Arms (3)

Stimulation order 1

EXPERIMENTAL

Stimulations delivered in following order: 1. Standard burst 2. Burst Microdosing 1 3. Burst Microdosing 2

Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol

Stimulation order 2

EXPERIMENTAL

Stimulations delivered in following order: 1. Burst Microdosing 1 2. Burst Microdosing 2 3. Standard burst

Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol

Stimulation order 3

EXPERIMENTAL

Stimulations delivered in following order: 1. Burst Microdosing 2 2. Standard burst 3. Burst Microdosing 1

Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol

Interventions

Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocolDEVICE

Stimulation parameters are reprogrammed from original values to study defined ones

Stimulation order 1Stimulation order 2Stimulation order 3

Eligibility Criteria

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

You may qualify if:

  • Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
  • Subject has been exclusively using burst stimulation for at least three months;
  • Subject is 18 years of age or older;
  • Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
  • Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
  • Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;

You may not qualify if:

  • Subject is currently participating in a clinical investigation study that includes an active treatment arm;
  • Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
  • Subject has a non SJM neuromodulation device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NKO Sint-Augustinus

Antwerp, 2610, Belgium

Location

Klinikum Duisburg GmbH

Duisburg, North Rhine-Westphalia, 47055, Germany

Location

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Filippo Agnesi, PhD
Organization
Abbott Neuromodulation
filippo.agnesi@abbott.com
972-526-4860

Study Officials

  • Lalit Venkatesan, Ph.D.

    Abbott Medical Devices

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 12, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 30, 2019

Results First Posted

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)DE(2)