Status:

COMPLETED

Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

National Center for Complementary and Integrative Health (NCCIH)

Conditions:

Chronic Pain

Failed Back Surgery Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Chronic intractable pain of the trunk and/or limbs
  • Undergoing SCS as part of standard clinical care for chronic pain management
  • Candidates will have been implanted with a commercial SCS device
  • Candidates who are 18 years or older and can speak, read, and understand English
  • Able to understand study procedures and to comply with them for the entire length of the study
  • Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit
  • Must be willing to wear a face-covering during all study visits
  • Exclusion criteria:
  • Subjects who are pregnant or nursing
  • Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail
  • Subjects who are unable or unwilling to cooperate with clinical testing
  • Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  • Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19

Exclusion

    Key Trial Info

    Start Date :

    September 11 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 18 2024

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT04732325

    Start Date

    September 11 2021

    End Date

    June 18 2024

    Last Update

    August 20 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Michigan

    Ann Arbor, Michigan, United States, 48109

    Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain | DecenTrialz