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Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Primary Purpose

Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal cord stimulation
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Spinal cord stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Burst / kHz / Sham / Tonic

Burst / Sham / kHz / Tonic

kHz / Sham / Burst / Tonic

kHz / Burst / Sham / Tonic

Sham / Burst / kHz / Tonic

Sham / kHz / Burst / Tonic

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

SCS-induced changes in temporal summation (TS)
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
October 6, 2023
Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04732325
Brief Title
Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain
Official Title
CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes, Neuropathic Pain
Keywords
Spinal cord stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Burst / kHz / Sham / Tonic
Arm Type
Experimental
Arm Description
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.
Arm Title
Burst / Sham / kHz / Tonic
Arm Type
Experimental
Arm Description
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.
Arm Title
kHz / Sham / Burst / Tonic
Arm Type
Experimental
Arm Description
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.
Arm Title
kHz / Burst / Sham / Tonic
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham / Burst / kHz / Tonic
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham / kHz / Burst / Tonic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
SCS-induced changes in temporal summation (TS)
Description
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.
Time Frame
Baseline (At randomization) and at the end of each seven-day treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Lempka, PhD
Phone
734-647-9052
Email
NeuromodulationLab@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lempka, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Lempka, PhD
Phone
734-647-9052
Email
NeuromodulationLab@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share IPD at this time.

Learn more about this trial

Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

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