Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain

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, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined 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 Overview

• Status: Completed
• Conditions: Chronic Pain; Complex Regional Pain Syndromes; Neuropathic Pain; Failed Back Surgery Syndrome
• Intervention / Treatment: Device: Spinal cord stimulation

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / 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; The spinal cord stimulation (SCS) system will be programmed 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; The spinal cord stimulation (SCS) system will be programmed 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; The spinal cord stimulation (SCS) system will be programmed 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; The spinal cord stimulation (SCS) system will be programmed 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; The spinal cord stimulation (SCS) system will be programmed 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; The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Cord Stimulation (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 were 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.	Up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS	Temporal summation (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 were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Tonic-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Tonic-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Tonic-SCS relative to Sham-SCS).	Up to 30 days
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS	Temporal summation (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 were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. The TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the kHz-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with kHz-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with kHz-SCS relative to Sham-SCS).	Up to 30 days
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS	Temporal summation (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 were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Burst-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Burst-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Burst-SCS relative to Sham-SCS).	Up to 30 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Scott Lempka, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2021
• Primary Completion (Actual): June 18, 2024
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Spinal cord stimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia; Complex Regional Pain Syndromes; Failed Back Surgery Syndrome; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Spinal Cord Stimulation
• Other Study ID Numbers: HUM00164430; R01AT010817 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share IPD at this time.

Drug and device information, study documents

• 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