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Completed

NCT Number: NCT03526055

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

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.

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Key information

Conditions

Spinal Cord Stimulation Back Pain Neurologic Manifestations Pain Pain, Back Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio Pain Clinic

Centerville, Ohio, 45459, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Algovita Spinal Cord Stimulation System

Device

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 outcomes

  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 outcomes

  1. Distribution of Paresthesia

    Time frame: Up to 8 days

    • 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

Sponsors and collaborators

Lead sponsor

Amol Soin

Other

Registry information

Official study title

Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 16, 2018
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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