Chronic PainNCT02346383
Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
A study testing preset program in people with Chronic Pain, run by Carolinas Center for Advanced Management of Pain at 1 site in United States.
Trial summary
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief Read more about this study
- Who is it for?
- Ages 22 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- preset program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2016
- 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 22 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spinal cord stimulator implant within last 3 weeks
- NRS > 6
- at least 22 years old
- patients who agree not to add or increase their pain medications during the study
Who cannot join
- patients with prior spinal cord stimulators
- pregnancy
- infusion pump
- history of substance abuse or dependency in last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Center For Advanced Management of Pain
Spartanburg, South Carolina, 29303
About this study
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Read the detailed description
Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
- Conditions
- Chronic Pain
- Being tested
- preset program
- Keywords
- back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preset programDevice
Also called epidural and peripheral lead to cover pain (Spinal Cord Stimulator)
Change to different present program using epidural and peripheral lead to cover pain
| Study group | Role | What they receive |
|---|---|---|
| program 1 | Active comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs Receives: Device: preset program |
| program 2 | Active comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs Receives: Device: preset program |
| program 3 | Active comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs Receives: Device: preset program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (Pain)
0 (no pain)- 10 (worst pain imaginable)
Measured: Weeks 4, 6 and 8
Secondary outcomes (1)
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
percentage of pain relief- self report
Measured: weeks 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startSep 2013
- Primary completionMay 2016
- Study completionJun 2016
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolinas Center for Advanced Management of Pain
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Eugene Mironer, M.D., Carolinas Center for Advanced Management of Pain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346383
- Sponsor's protocol ID
- 7175
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2013
- Last updated
- 16 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Stimulation Programming for Spinal Peripheral Neuromodulation
- ClinicalTrials.gov ID
- NCT02346383
- Acronym / sponsor ID
- 7175
- Conditions
- Chronic Pain
- Keywords
- back pain, neuromodulation, spinal peripheral neuromodulation, spinal cord stimulation, postlaminectomy pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Carolinas Center for Advanced Management of PainUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Sep 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Detailed description
Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| program 1 | Active comparator | Device: preset programpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
| program 2 | Active comparator | Device: preset programpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
| program 3 | Active comparator | Device: preset programpreset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- spinal cord stimulator implant within last 3 weeks
- NRS > 6
- at least 22 years old
- patients who agree not to add or increase their pain medications during the study
Key exclusion criteria (4 listed)
- patients with prior spinal cord stimulators
- pregnancy
- infusion pump
- history of substance abuse or dependency in last 6 months
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 |
|---|---|---|
| preset programAlso: epidural and peripheral lead to cover pain (Spinal Cord Stimulator)Change to different present program using epidural and peripheral lead to cover pain | Device | program 1, program 2, program 3 |
Primary outcome
Numeric Rating Scale (Pain)
Time frame: Weeks 4, 6 and 8
0 (no pain)- 10 (worst pain imaginable)
1 secondary outcome
Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program.
Time frame: weeks 4, 6, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preset program in people with Chronic Pain, run by Carolinas Center for Advanced Management of Pain 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: finished, as of the sponsor's last update on 16 Mar 2021. 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 16 Mar 2021). 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?
Numeric Rating Scale (Pain) (time frame: Weeks 4, 6 and 8). 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 16 Mar 2021.