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Completed

NCT Number: NCT03756012

Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

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

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Key information

Conditions

Back Pain Neurologic Manifestations Pain 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

The Ohio Pain Clinic

Centerville, Ohio, 45458, United States

About this study

The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. 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 Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six 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

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

Exclusion criteria

  • be contraindicated for an Algovita® SCS system
  • have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
  • have a life expectancy of less than 2 years
  • be participating in another clinical study that would confound data analysis
  • have a coexisting pain condition that might confound pain ratings
  • have 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. Effect of Pulse Widths on Pain Clinical Outcomes

    Time frame: For 7 days following intervention

    To evaluate the effect of conventional pulse widths <500 μsec and pulse widths >1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps.

Secondary outcomes

  1. Change in Targeted Pain

    Time frame: For 7 days following intervention

    To evaluate the effect of conventional pulse widths <500μsecand pulse widths and >1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period.

  2. Distribution of Paesthesia

    Time frame: For 7 days following intervention

    At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.

  3. Research Participant Program Preference

    Time frame: For 7 days following intervention

    At the end of the trial period, subjects will be asked to select their favorite program.

  4. Quality of Pain Relief

    Time frame: For 7 days following intervention

    At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor

  5. Research Participant Pain Relief Satisfaction

    Time frame: For 7 days following intervention

    At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied

  6. ≥ 50% Pain Relief

    Time frame: For 7 days following intervention

    Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)

  7. Rate of AEs

    Time frame: For 7 days following intervention

    Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.

Sponsors and collaborators

Lead sponsor

Kettering Health Network

Other

Collaborators

  • Ohio Pain Clinic

Registry information

Official study title

Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Mar 8, 2021

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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