Chronic Low Back and Leg PainNCT00737581
Spinal Cord Stimulation Research Study
An observational study of Chronic Low Back and Leg Pain, run by MedtronicNeuro at 2 sites in United States.
Trial summary
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back and Leg Pain
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Apr 2009
- 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 spinal cord stimulator.
Who may be able to join
- Be ambulatory
- Be 18 years of age or older
- Have chronic low back pain and/or leg pain due to neuropathic causes
- Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
- Be implanted with percutaneous thoracic leads
- Have stable pain control
Show all 10Show fewer
- Adjust stimulation parameters manually on a regular basis
- Be willing and able to complete protocol requirements
- Be willing and able to provide written informed consent
- Be male or nonpregnant female
Who cannot join
- Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
- Be morbidly obese
- Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, 55435
Center for Pain Control
Garland, Texas, 75042
About this study
Official title: Posture Responsive Spinal Cord Stimulation Research Study
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.
- Conditions
- Chronic Low Back and Leg Pain
- Keywords
- Subject's, response, changes, in spinal, cord, stimulation, during, postural
- Medical subject headings
- Cone-Rod Dystrophies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back and Leg 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David M Schultz, MD, Principal investigator, Medical Advanced Pain SpecialistsCristy Schade, MD, Principal investigator, Center for Pain Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737581
- Sponsor's protocol ID
- 1648
- Status last verified
- Jan 2017
- First submitted
- 15 Aug 2008
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Responsive Spinal Cord Stimulation Research Study
- ClinicalTrials.gov ID
- NCT00737581
- Acronym / sponsor ID
- 1648
- Conditions
- Chronic Low Back and Leg Pain
- Keywords
- Subject's, response, changes, in spinal, cord, stimulation, during, postural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Aug 2008 (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.
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
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 spinal cord stimulator.
Key inclusion criteria (10 listed)
- Be ambulatory
- Be 18 years of age or older
- Have chronic low back pain and/or leg pain due to neuropathic causes
- Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
- Be implanted with percutaneous thoracic leads
Key exclusion criteria (3 listed)
- Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
- Be morbidly obese
- Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 1 Feb 2017.
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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.
David M Schultz, MD principal investigator
Medical Advanced Pain Specialists
Cristy Schade, MD principal investigator
Center for Pain Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back and Leg Pain, run by MedtronicNeuro at 2 sites 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 10 inclusion and 3 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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.
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 1 Feb 2017.