NCT03526055

Brief Summary

The purpose of this study is to evaluate the effect of pulse widths \<500 µS and \>1000 µS on clinical outcomes during a temporary SCS trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

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

February 26, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 21, 2019

Completed
Last Updated

February 21, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

March 6, 2018

Results QC Date

November 12, 2018

Last Update Submit

January 31, 2019

Conditions

Spinal Cord StimulationPain, BackPain

Outcome Measures

Primary Outcomes (1)

  • Subject Pain Relief

    The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.

    up to 8 days

Secondary Outcomes (6)

  • Distribution of Paresthesia

    Up to 8 days

  • Subject Preference

    Up to 8 days

  • Quality of Pain Relief

    Up to 8 days

  • Subject Satisfaction

    Up to 8 days

  • Achievement of ≥50% Pain Relief

    Up to 8 days

  • +1 more secondary outcomes

Study Arms (2)

<500 µS Pulse Width

ACTIVE COMPARATOR

Intervention includes spinal cord stimulation will be programmed to \<500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

Device: Algovita Spinal Cord Stimulation System

>1000 µS Pulse Width

EXPERIMENTAL

Intervention includes spinal cord stimulation will be programmed to \>1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

Device: Algovita Spinal Cord Stimulation System

Interventions

Algovita Spinal Cord Stimulation SystemDEVICE

The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

<500 µS Pulse Width>1000 µS Pulse Width

Eligibility Criteria

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

You may qualify if:

  • Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
  • Study candidate is undergoing a SCS trial using Nuvectra Algostim system
  • Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
  • Subject is 18 years of age or older when written informed consent is obtained

You may not qualify if:

  • Subject is contraindicated for an Algovita SCS system
  • Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
  • Subject has a life expectancy of less than 2 years
  • Subject is participating in another clinical study that would confound data analysis
  • Subject has a coexisting pain condition that might confound pain ratings
  • Subject has a significant psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio Pain Clinic

Centerville, Ohio, 45459, United States

Location

Related Publications (12)

  • American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.

    BACKGROUND

  • North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, Rybock JD, Long DM. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery. 1991 May;28(5):685-90; discussion 690-1.

    PMID: 1831546BACKGROUND

  • Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.

    BACKGROUND

  • Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63. doi: 10.3171/jns.1978.48.2.0259.

    PMID: 146731BACKGROUND

  • Lehmann TR, LaRocca HS. Repeat lumbar surgery. A review of patients with failure from previous lumbar surgery treated by spinal canal exploration and lumbar spinal fusion. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):615-9.

    PMID: 6461073BACKGROUND

  • Jobling DT, Tallis RC, Sedgwick EM, Illis LS. Electronic aspects of spinal-cord stimulation in multiple sclerosis. Med Biol Eng Comput. 1980 Jan;18(1):48-56. doi: 10.1007/BF02442479. No abstract available.

    PMID: 6966725BACKGROUND

  • Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. doi: 10.1159/000102196.

    PMID: 6975071BACKGROUND

  • Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997 May;40(5):990-6; discussions 996-9. doi: 10.1097/0006123-199705000-00023.

    PMID: 9149258BACKGROUND

  • Gould B, Bradley K. Pulse width programming in spinal cord stimulators. Abstract of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22-25. San Diego, CA

    BACKGROUND

  • Yearwood TL, Hershey B, Bradley K, Lee D. Pulse width programming in spinal cord stimulation: a clinical study. Pain Physician. 2010 Jul-Aug;13(4):321-35.

    PMID: 20648201BACKGROUND

  • Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.

    PMID: 21528381BACKGROUND

  • Grill WM Jr, Mortimer JT. The effect of stimulus pulse duration on selectivity of neural stimulation. IEEE Trans Biomed Eng. 1996 Feb;43(2):161-6. doi: 10.1109/10.481985.

    PMID: 8682527BACKGROUND

MeSH Terms

Conditions

Back PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Amol Soin
Organization
Ohio Pain Clinic
drsoin@ohiopainclinic.com
937-434-2226

Study Officials

  • Amol Soin, MD, MBA

    Ohio Pain Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2018

First Posted

May 16, 2018

Study Start

February 26, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

February 21, 2019

Results First Posted

February 21, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)