Chronic PainNCT04732325
Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain
A study testing Spinal cord stimulation in people with Chronic Pain and Failed Back Surgery Syndrome, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2021to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes, Neuropathic Pain
- Being tested
- Spinal cord stimulation
- Keywords
- Spinal cord stimulation
- Medical subject headings
- Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Burst / kHz / Sham / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
| Burst / Sham / kHz / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
| kHz / Sham / Burst / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
| kHz / Burst / Sham / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
| Sham / Burst / kHz / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
| Sham / kHz / Burst / Tonic | Experimental | 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. Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start11 Sep 2021
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Scott Lempka, University of Michigan
- Investigators
- Scott Lempka, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732325
- Sponsor's protocol ID
- HUM00164430
- Other IDs
- R01AT010817
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain
- ClinicalTrials.gov ID
- NCT04732325
- Acronym / sponsor ID
- HUM00164430
- Conditions
- Chronic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes, Neuropathic Pain
- Keywords
- Spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
| Arm | Type | Receives |
|---|---|---|
| Burst / kHz / Sham / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
| Burst / Sham / kHz / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
| kHz / Sham / Burst / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
| kHz / Burst / Sham / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
| Sham / Burst / kHz / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
| Sham / kHz / Burst / Tonic | Experimental | Device: Spinal cord stimulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationThe spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation. | Device | Burst / Sham / kHz / Tonic, Burst / kHz / Sham / Tonic, Sham / Burst / kHz / Tonic, Sham / kHz / Burst / Tonic, kHz / Burst / Sham / Tonic, kHz / Sham / Burst / Tonic |
Primary outcome
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)
Time frame: Up to 30 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There are no plans to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Lempka, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Chronic Pain and Failed Back Surgery Syndrome, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.