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Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

Primary Purpose

Spinal Cord Stimulation, Pain, Back, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Algovita Spinal Cord Stimulation System
Sponsored by
Amol Soin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Ohio Pain Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

<500 µS Pulse Width

>1000 µS Pulse Width

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Distribution of Paresthesia
1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Subject Preference
Subjects will be asked to select their favorite program
Quality of Pain Relief
Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor
Subject Satisfaction
Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Achievement of ≥50% Pain Relief
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). 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.
Rate of AEs
Rate of device-related and/or procedure-related AEs

Full Information

First Posted
March 6, 2018
Last Updated
January 31, 2019
Sponsor
Amol Soin
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1. Study Identification

Unique Protocol Identification Number
NCT03526055
Brief Title
Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial
Official Title
Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amol Soin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days. The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Stimulation, Pain, Back, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
<500 µS Pulse Width
Arm Type
Active Comparator
Arm Description
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.
Arm Title
>1000 µS Pulse Width
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Algovita Spinal Cord Stimulation System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subject Pain Relief
Description
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.
Time Frame
up to 8 days
Secondary Outcome Measure Information:
Title
Distribution of Paresthesia
Description
1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Time Frame
Up to 8 days
Title
Subject Preference
Description
Subjects will be asked to select their favorite program
Time Frame
Up to 8 days
Title
Quality of Pain Relief
Description
Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor
Time Frame
Up to 8 days
Title
Subject Satisfaction
Description
Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Time Frame
Up to 8 days
Title
Achievement of ≥50% Pain Relief
Description
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). 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.
Time Frame
Up to 8 days
Title
Rate of AEs
Description
Rate of device-related and/or procedure-related AEs
Time Frame
From spinal cord stimulation implant through study completion or study exit, Up to 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol Soin, MD, MBA
Organizational Affiliation
Ohio Pain Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio Pain Clinic
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
Results Reference
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PubMed Identifier
1831546
Citation
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.
Results Reference
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Citation
Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
Results Reference
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PubMed Identifier
146731
Citation
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.
Results Reference
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PubMed Identifier
6461073
Citation
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.
Results Reference
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PubMed Identifier
6966725
Citation
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.
Results Reference
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PubMed Identifier
6975071
Citation
Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. doi: 10.1159/000102196.
Results Reference
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PubMed Identifier
9149258
Citation
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.
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Citation
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
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PubMed Identifier
20648201
Citation
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.
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PubMed Identifier
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Citation
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.
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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.
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Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

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