Spinal Cord StimulationNCT07709351
Prospective Evaluation of the Optimal SCS Trial Length
An observational study of Spinal Cord Stimulation, run by Ohio State University at 1 site in United States.
Trial summary
This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Stimulation
- What is being tested?
- Spinal Cord Stimulation (SCS) Trial
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2026to 31 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Certain populations will be excluded to minimize factors that may influence pain reporting, treatment response, and SCS trial outcomes. Exclusions include pregnant individuals, those involved in active worker's compensation claims, patients with prior failed SCS trials, and individuals using chronic opioids exceeding 50 MME/day. These criteria help ensure participant safety, reduce potential confounding variables, and improve the accuracy and validity of the study findings.
Who may be able to join
- Adults aged 18 years or older who are able to provide informed consent.
- Individuals with a clinical diagnosis of a chronic pain condition deemed appropriate for spinal cord stimulation (SCS) therapy by the treating physician.
- Individuals with a documented duration of chronic pain greater than 12 weeks.
- Individuals scheduled to undergo a spinal cord stimulation trial as part of routine clinical care at a participating site.
Who cannot join
- Pregnant individuals.
- Individuals currently receiving or involved in a worker's compensation claim related to their pain condition.
- Individuals with a history of a previously failed spinal cord stimulation (SCS) trial.
- Individuals with chronic opioid use exceeding 50 morphine milligram equivalents (MME) per day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University
Columbus, Ohio, 43210
Nasir Hussain, MD, 614-293-3559, Nasir.Hussain@osumc.edu
About this study
This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.
Read the detailed description
Spinal cord stimulation (SCS) is an established treatment for chronic pain and is typically preceded by a temporary trial period to evaluate treatment effectiveness before permanent implantation. Standard SCS trial durations generally range from 3 to 7 days, although some trials may be extended up to 15 days. These timeframes are largely intended to minimize the risk of epidural infection associated with prolonged epidural lead placement. However, there is limited evidence defining the optimal duration of an SCS trial, raising the possibility that many trials may be longer than clinically necessary (1).
Reducing the duration of SCS trials could provide several clinical benefits. Shorter trials may decrease the risk of infection, reduce the need for prophylactic antibiotic exposure, and minimize the length of time patients must interrupt antiplatelet or anticoagulant therapy when applicable. Determining the shortest trial duration that reliably predicts treatment success could improve patient safety while streamlining clinical care.
This study aims to identify the optimal duration of the SCS trial by evaluating daily pain scores, patient satisfaction, and the timing of patients' decisions to proceed with permanent SCS implantation. The primary objective is to determine the minimum number of trial days required to accurately predict SCS trial success. The secondary objective is to evaluate the association between SCS trial outcomes and patient-reported outcome measures, including PROMIS domain scores and candidacy recommendations generated by the SCS E-Health Tool, to assess their ability to predict SCS candidacy and treatment outcomes.
- Conditions
- Spinal Cord Stimulation
- Being tested
- Spinal Cord Stimulation (SCS) Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation (SCS) TrialProcedure or surgery
This observational study will enroll approximately 42 subjects at The Ohio State University who are undergoing a spinal cord stimulation (SCS) trial as part of standard clinical care. No study-specific intervention will be assigned. Participants will be monitored to evaluate SCS trial outcomes, including pain scores, patient satisfaction, and decisions regarding permanent implantation. The sample size was selected to provide sufficient evaluable data while accounting for potential attrition and supporting descriptive and exploratory analyses.
| Study group | Role | What they receive |
|---|---|---|
| SCS Trial Participants | Participants undergoing a standard spinal cord stimulation (SCS) trial as part of routine clinical care will be observed. Daily pain scores, patient satisfaction, and decision-making regarding permanent SCS implantation will be collected during the trial period. No study-specific intervention will be administered; the study evaluates outcomes associated with the existing SCS trial process. Receives: Procedure: Spinal Cord Stimulation (SCS) Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes
Determining the minimum number of days required to accurately predict SCS trial outcomes.
Measured: 15 days
Secondary outcomes (2)
Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome
Assessment of the correlation between baseline Patient-Reported Outcomes Measurement Information System (PROMIS) domain T-scores (Pain Interference, Physical Function, Depression, Anxiety, and Sleep Disturbance) and the final spinal cord stimulation (SCS) trial outcome (successful vs. unsuccessful trial).
Measured: 15 days
Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome
Assessment of the correlation between the baseline SCS E-Health Tool candidacy recommendation and the final spinal cord stimulation (SCS) trial outcome (successful vs. unsuccessful trial).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start28 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709351
- Sponsor's protocol ID
- STUDY20250590
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The current study plan does not indicate an intention to make individual participant data (IPD) available to other researchers. Study findings will be analyzed and reported in aggregate form, and no external sharing of participant-level data is planned.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Optimal SCS Trial Length
- ClinicalTrials.gov ID
- NCT07709351
- Acronym / sponsor ID
- STUDY20250590
- Conditions
- Spinal Cord Stimulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the ideal length of a spinal cord stimulation (SCS) trial period by analyzing daily pain scores, patient satisfaction, and when patients decide whether to proceed with permanent implantation. The primary goal is to identify the shortest trial duration that can reliably predict SCS success. A secondary goal is to compare SCS trial outcomes with patient-reported health measures (PROMIS domains) and recommendations from the SCS E-Health Tool to evaluate how well these tools predict treatment candidacy and outcomes.
Detailed description
Spinal cord stimulation (SCS) is an established treatment for chronic pain and is typically preceded by a temporary trial period to evaluate treatment effectiveness before permanent implantation. Standard SCS trial durations generally range from 3 to 7 days, although some trials may be extended up to 15 days. These timeframes are largely intended to minimize the risk of epidural infection associated with prolonged epidural lead placement. However, there is limited evidence defining the optimal duration of an SCS trial, raising the possibility that many trials may be longer than clinically necessary (1).
Reducing the duration of SCS trials could provide several clinical benefits. Shorter trials may decrease the risk of infection, reduce the need for prophylactic antibiotic exposure, and minimize the length of time patients must interrupt antiplatelet or anticoagulant therapy when applicable. Determining the shortest trial duration that reliably predicts treatment success could improve patient safety while streamlining clinical care.
This study aims to identify the optimal duration of the SCS trial by evaluating daily pain scores, patient satisfaction, and the timing of patients' decisions to proceed with permanent SCS implantation. The primary objective is to determine the minimum number of trial days required to accurately predict SCS trial success. The secondary objective is to evaluate the association between SCS trial outcomes and patient-reported outcome measures, including PROMIS domain scores and candidacy recommendations generated by the SCS E-Health Tool, to assess their ability to predict SCS candidacy and treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS Trial Participants | – | Procedure: Spinal Cord Stimulation (SCS) TrialParticipants undergoing a standard spinal cord stimulation (SCS) trial as part of routine clinical care will be observed. Daily pain scores, patient satisfaction, and decision-making regarding permanent SCS implantation will be collected during the trial period. No study-specific intervention will be administered; the study evaluates outcomes associated with the existing SCS trial process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Certain populations will be excluded to minimize factors that may influence pain reporting, treatment response, and SCS trial outcomes. Exclusions include pregnant individuals, those involved in active worker's compensation claims, patients with prior failed SCS trials, and individuals using chronic opioids exceeding 50 MME/day. These criteria help ensure participant safety, reduce potential confounding variables, and improve the accuracy and validity of the study findings.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older who are able to provide informed consent.
- Individuals with a clinical diagnosis of a chronic pain condition deemed appropriate for spinal cord stimulation (SCS) therapy by the treating physician.
- Individuals with a documented duration of chronic pain greater than 12 weeks.
- Individuals scheduled to undergo a spinal cord stimulation trial as part of routine clinical care at a participating site.
Key exclusion criteria (4 listed)
- Pregnant individuals.
- Individuals currently receiving or involved in a worker's compensation claim related to their pain condition.
- Individuals with a history of a previously failed spinal cord stimulation (SCS) trial.
- Individuals with chronic opioid use exceeding 50 morphine milligram equivalents (MME) per day.
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 Stimulation (SCS) TrialThis observational study will enroll approximately 42 subjects at The Ohio State University who are undergoing a spinal cord stimulation (SCS) trial as part of standard clinical care. No study-specific intervention will be assigned. Participants will be monitored to evaluate SCS trial outcomes, including pain scores, patient satisfaction, and decisions regarding permanent implantation. The sample size was selected to provide sufficient evaluable data while accounting for potential attrition and supporting descriptive and exploratory analyses. | Procedure or surgery | SCS Trial Participants |
Primary outcome
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes
Time frame: 15 days
Determining the minimum number of days required to accurately predict SCS trial outcomes.
2 secondary outcomes
Correlation Between Baseline PROMIS Domain T-Scores and Final SCS Trial Outcome
Time frame: 15 days
Correlation Between Baseline SCS E-Health Tool Candidacy Recommendation and Final SCS Trial Outcome
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. The current study plan does not indicate an intention to make individual participant data (IPD) available to other researchers. Study findings will be analyzed and reported in aggregate form, and no external sharing of participant-level data is planned.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Stimulation, run by Ohio State University 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nasir Hussain, MD (6142933559, Nasir.Hussain@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the Minimum SCS Trial Duration Predictive of Clinical Outcomes (time frame: 15 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 6 Oct 2026.