Skip to main content
OpenTrials
Completed

NCT Number: NCT05283863

Direct Comparison of Spinal Cord Stimulator Parameter Settings

(Primary)

1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes implanted for chronic pain as measured by the Visual Analog Pain Scale for back and leg pain, the Brief Pain Inventory, the 36-Item Short Form Survey (SF-36), and the Pain Vigilance and Awareness Questionnaire.

(Secondary) 2. To compare the clinical effects of the subthreshold (paresthesia-free) stimulation patterns with conventional (paresthesia-producing) stimulation patterns to evaluate the necessity of paresthesias and current amplitudes on clinical benefit for pain. 3. To identify the ability of subthreshold high-frequency to improve axial pain or the affective component of pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Stimulation High-density Stimulation High-frequency Stimulation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44122, United States

About this study

This is a prospective, randomized, double-blind study of different stimulation patterns in patients undergoing implantation of neurostimulator systems for chronic medically intractable neuropathic pain. Research participants will be individuals who have undergone implantation of neurostimulator electrodes into the spinal column or peripheral nervous system for clinical treatment of neuropathic pain. All patients will already have undergone empiric programming of the stimulator using conventional settings (typically 40-60 Hz, 350-450 usec pulse width). However, other stimulation parameters, including high-frequency stimulation, are also feasible and FDA-approved using the implanted device, and it is possible to do this without producing a sensory percept, which makes it possible to test efficacy in a double blind manner. For this study, two different stimulation parameters will be tested during four two-week periods: 1000 Hz and placebo. Clinical response and side effect profile for each setting will be measured.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years
  • Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
  • History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator

Exclusion criteria

  • Significant dementia or other condition preventing informed consent by the patient.
  • Current drug or alcohol abuse or dependence.
  • Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
  • Inability or unwillingness to cooperate with clinical testing.

Treatment and study plan

High-frequency stimulation

Device

Patients in this group will receive sub-threshold high-frequency (aka 1200Hz) spinal cord stimulation for 2 weeks.

Sham stimulation

Device

Patients in this group will receive receive sham spinal cord stimulation (aka no stimulation) for 2 weeks.

Primary outcomes

  1. Visual Analog Pain Scale

    Time frame: 8 weeks

    Assessment of overall degree of back and leg pain during each phase of stimulation (ie conventional baseline stimulation, high-density stimulation, conventional "washout" stimulation, and sham stimulation). Scores range from 0 - 100, with a higher score indicating more pain.

Secondary outcomes

  1. Change in Brief Pain Inventory (BPI)

    Time frame: 8 weeks

    The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). Each item is rated on a scale of 0 - 10 with 10 indicating higher levels of pain. For purposes of this outcome measure, we focused on "now" (current pain)

  2. Change in SF-36

    Time frame: 8 weeks

    The SF-36 is a measure of quality of life, with scores ranging from 0 - 100, with higher scores indicating a higher quality of life.

  3. Pain Vigilance and Awareness Questionnaire (PVAQ)

    Time frame: 8 weeks

    The PVAQ is a measure of vigilance and attention to pain. Total scores can range from 0 to 90, with higher scores indicating more pain vigilance.

  4. Number of Patients With Side Effects of Stimulation

    Time frame: 8 weeks

    Incidence of side effects of stimulation

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2022
Registry last updated
May 21, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.