NCT04708392

Brief Summary

This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2017

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

July 29, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

July 7, 2020

Last Update Submit

January 13, 2021

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Quantitative Stimulus Testing (QST)-Thermal

    Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.

    Change from baseline to 4 weeks

Secondary Outcomes (10)

  • McGill Pain Questionnaire (MPQ)

    Change from baseline to 4 weeks

  • Oswestry Disability Index (ODI)

    Change from baseline to 4 weeks

  • Beck's Depression Inventory (BDI)

    Change from baseline to 4 weeks

  • Pain Catastrophizing Scale (PCS)

    Change from baseline to 4 weeks

  • Numerical Rating Scale (NRS)

    Change from baseline to 4 weeks

  • +5 more secondary outcomes

Study Arms (2)

Tonic spinal cord stimulation

EXPERIMENTAL

Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.

Device: Spinal Cord Stimulator

Burst spinal cord stimulation

EXPERIMENTAL

Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.

Device: Spinal Cord Stimulator

Interventions

Spinal Cord StimulatorDEVICE

A spinal cord stimulator is a surgically implanted device that delivers an electrical signal to a patient's spinal cord to reduce the perception of pain

Burst spinal cord stimulationTonic spinal cord stimulation

Eligibility Criteria

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

You may qualify if:

  • Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
  • Patients are \>/= 18 years old at the time of enrollment.
  • Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.

You may not qualify if:

  • Patients less than 18 years old.
  • Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (3)

  • Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.

    PMID: 28961366BACKGROUND

  • Hou S, Kemp K, Grabois M. A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Neuromodulation. 2016 Jun;19(4):398-405. doi: 10.1111/ner.12440. Epub 2016 May 3.

    PMID: 27139915BACKGROUND

  • De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.

    PMID: 23321375BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julie Pilitsis, MD, PhD

    AMC Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

January 14, 2021

Study Start

July 29, 2017

Primary Completion

July 31, 2018

Study Completion

September 11, 2018

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)