N/A
N=25
Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain
Chronic Pain · Failed Back Surgery Syndrome · Complex Regional Pain Syndromes · Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04732325 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) — 3.67; 3.33; 3.67; 3.33 score on a scale — p=0.2375
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinal cord stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) |
3.67; 3.33; 3.67; 3.33; 8.33; 5.67 | 0.2375 |
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, 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.
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
Data sourced from ClinicalTrials.gov (NCT04732325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.