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Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04732325
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Scott Lempka, University of Michigan

Study Description
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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 therapy is spinal cord stimulation (SCS). In this study, researchers want to learn more about how SCS affects pain processing and relieves pain. The researchers will examine multiple forms of SCS in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

Condition or disease Intervention/treatment Phase
Chronic Pain Failed Back Surgery Syndrome Complex Regional Pain Syndromes Neuropathic Pain Device: Spinal cord stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: There will be two research teams. One team will be unblinded (e.g., clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g., research personnel) and will perform clinical testing and collect study outcome measures.
Primary Purpose: Treatment
Official Title: CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain
Actual Study Start Date : September 11, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Burst / kHz / Sham / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Burst / Sham / kHz / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Sham / Burst / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Burst / Sham / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / Burst / kHz / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / kHz / Burst / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
 Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.


Outcome Measures
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Primary Outcome Measures :
  1. SCS-induced changes in temporal summation (TS) [ Time Frame: Baseline (At randomization) and at the end of each seven-day treatment ]
    TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores will be calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04732325


Contacts
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Contact: Jessica Loechli, BSc 734-647-9052 jloechli@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jessica Loechli, BSc    734-647-9052    jloechli@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Scott Lempka, PhD University of Michigan
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Scott Lempka, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04732325    
Other Study ID Numbers: HUM00164430
R01AT010817 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share IPD at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Scott Lempka, University of Michigan:
Spinal cord stimulation
Additional relevant MeSH terms:
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Neuralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Chronic Pain
Failed Back Surgery Syndrome
Disease
Pathologic Processes
 Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autonomic Nervous System Diseases
Postoperative Complications
Back Pain