PainPAIN RegistryNCT01305525
A Prospective Clinical Outcomes Registry
An observational study of Pain, run by Abbott Medical Devices at 32 sites in 2 countries.
Trial summary
This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- St. Jude Medical Spinal Cord Stimulation Systems
- Type of treatment
- Medical device
- How many people
- 614 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Jun 2009to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients implanted with a neuromodulation system
Who may be able to join
- Patient has signed and received a copy of the Informed Consent form;
- Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
- Patient is 18 years of age or older.
- Patient is not currently participating in another clinical trial.
Who cannot join
- None
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
Study site
Arlington, Virginia
Study site
Azusa, California
Study site
Baton Rouge, Louisiana
Study site
Bethlehem, Pennsylvania
Study site
Bloomfield Hills, Michigan
Study site
Charleston, West Virginia
Study site
Chula Vista, California
Study site
Durham, North Carolina
Study site
Edmonds, Washington
Study site
Evansville, Indiana
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kalispell, Montana
Study site
Kirkland, Washington
Study site
Louisville, Kentucky
Study site
Mansfield, Ohio
Study site
Morgantown, West Virginia
Study site
Muncie, Indiana
Study site
New York, New York
Study site
Purcell, Oklahoma
Study site
Sacramento, California
Study site
Saint Paul, Minnesota
Study site
Scottsdale, Arizona
Study site
Southlake, Texas
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Utica, New York
Study site
Waterford, Michigan
Study site
Webster, Texas
Study site
Williamsville, New York
Study site
Winston-Salem, North Carolina
About this study
Official title: Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry
This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.
Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.
- Conditions
- Pain
- Being tested
- St. Jude Medical Spinal Cord Stimulation Systems
- Keywords
- SCS, St. Jude Medical, Neuromodulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. Jude Medical Spinal Cord Stimulation SystemsDevice
Spinal cord stimulation
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Not described Receives: Device: St. Jude Medical Spinal Cord Stimulation Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcomes over time
The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305525
- Sponsor's protocol ID
- C-09-01
- Acronym
- PAIN Registry
- Status last verified
- Jan 2019
- First submitted
- 25 Feb 2011
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry
- ClinicalTrials.gov ID
- NCT01305525
- Acronym / sponsor ID
- PAIN Registry / C-09-01
- Conditions
- Pain
- Keywords
- SCS, St. Jude Medical, Neuromodulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Feb 2011 (estimated)
- 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 is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.
Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | – | Device: St. Jude Medical Spinal Cord Stimulation Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a neuromodulation system
Key inclusion criteria (4 listed)
- Patient has signed and received a copy of the Informed Consent form;
- Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
- Patient is 18 years of age or older.
- Patient is not currently participating in another clinical trial.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| St. Jude Medical Spinal Cord Stimulation SystemsSpinal cord stimulation | Device | Spinal Cord Stimulation |
Primary outcome
Patient reported outcomes over time
Time frame: 2 years
The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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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.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Abbott Medical Devices at 32 sites in 2 countries.
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 1 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient reported outcomes over time (time frame: 2 years). 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 30 Jan 2019.