NCT02787265

Brief Summary

This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

May 26, 2016

Last Update Submit

January 28, 2021

Conditions

Failed Back Surgery Syndrome

Keywords

High density spinal cord stimulationVirtual expert registry

Outcome Measures

Primary Outcomes (6)

  • Pain intensity with the Numeric Rating Scale (NRS)

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • Pain relief by pain medication

    Questionnaire regarding the amount of pain relief by pain medication

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • The abilities in daily living

    The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • The current health status

    The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • Subjective sleep quality

    Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • Patient's satisfaction

    Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale

    The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

Secondary Outcomes (6)

  • Pain area coverage

    The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • Paresthesia threshold

    The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • HD stim parameters

    The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • Battery efficiency of the neurostimulator

    The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • AdaptiveStim use (in case of Restore Sensor)

    The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.

  • +1 more secondary outcomes

Study Arms (1)

spinal cord stimulation

Failed back surgery syndrome patients will receive high density spinal cord stimulation

Device: spinal cord stimulation

Interventions

spinal cord stimulationDEVICE
Also known as: high density spinal cord stimulation
spinal cord stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.

You may qualify if:

  • Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
  • Age \> 18 years
  • Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
  • Patient has been informed of the study procedures and has given written informed consent
  • Patient willing to comply with study protocol including attending the study visits

You may not qualify if:

  • Expected inability of patients to receive or properly operate the spinal cord stimulation system
  • History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
  • Active malignancy
  • Addiction to any of the following drugs, alcohol (5E/day) and/or medication
  • Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
  • Immune deficiency (HIV positive, immunosuppressiva, etc.)
  • Life expectancy \< 1 year
  • Local infection or other skin disorder at site of incision
  • Pregnancy
  • Other implanted active medical device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, Belgium

Location

Related Publications (4)

  • Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.

    PMID: 26344573BACKGROUND

  • Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.

    PMID: 26481726BACKGROUND

  • Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.

    PMID: 35551868DERIVED

  • Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.

    PMID: 32910099DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

June 1, 2016

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

BE(1)