Clinical trial NCT04732325: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Failed Back Surgery Syndrome
Complex Regional Pain Syndromes
Neuropathic Pain
Keywords: Spinal cord stimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-02-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: SCS-induced changes in temporal summation (TS)
timeFrame: Baseline (At randomization) and at the end of each seven-day treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Scott Lempka, PhD
role: PRINCIPAL_INVESTIGATOR
References: