Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

University of Michigan

Status: Completed

Conditions: Complex Regional Pain Syndromes; Neuropathic Pain; Chronic Pain; Failed Back Surgery Syndrome

Treatments: Device: Spinal cord stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04732325

R01AT010817 (U.S. NIH Grant/Contract)

HUM00164430

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 6 patient groups

Burst / kHz / Sham / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation

Burst / Sham / kHz / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation

kHz / Sham / Burst / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation

kHz / Burst / Sham / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation

Sham / Burst / kHz / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation

Sham / kHz / Burst / Tonic

Experimental group

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.

Treatment:

Device: Spinal cord stimulation