Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

University of Michigan34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline (At randomization) and at the end of each seven-day treatment