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

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ClinicalTrials.gov Identifier: NCT03526055
Recruitment Status : Completed
First Posted : May 16, 2018
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Amol Soin, Kettering Health Network

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Stimulation Pain, Back Pain Device: Algovita Spinal Cord Stimulation System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Arm Intervention/treatment
Active Comparator: <500 µS Pulse Width
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
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.

Experimental: >1000 µS Pulse Width
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
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 Measures :
  1. Subject Pain Relief [ Time Frame: up to 8 days ]
    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 :
  1. Distribution of Paresthesia [ Time Frame: Up to 8 days ]
    1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.

  2. Subject Preference [ Time Frame: Up to 8 days ]
    Subjects will be asked to select their favorite program

  3. Quality of Pain Relief [ Time Frame: Up to 8 days ]
    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

  4. Subject Satisfaction [ Time Frame: Up to 8 days ]
    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

  5. Achievement of ≥50% Pain Relief [ Time Frame: Up to 8 days ]
    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.

  6. Rate of AEs [ Time Frame: From spinal cord stimulation implant through study completion or study exit, Up to 8 days ]
    Rate of device-related and/or procedure-related AEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526055


Locations
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United States, Ohio
Ohio Pain Clinic
Centerville, Ohio, United States, 45459
Sponsors and Collaborators
Amol Soin
Investigators
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Principal Investigator: Amol Soin, MD, MBA Ohio Pain Clinic
  Study Documents (Full-Text)

Documents provided by Amol Soin, Kettering Health Network:
Study Protocol  [PDF] January 26, 2018
No Statistical Analysis Plan (SAP) exists for this study.


Publications:
American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
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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Responsible Party: Amol Soin, Principal Investigator, Kettering Health Network
ClinicalTrials.gov Identifier: NCT03526055     History of Changes
Other Study ID Numbers: Long Pulse
First Posted: May 16, 2018    Key Record Dates
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms