Chronic Low Back and Leg PainADR-SCSNCT00768872
Spinal Cord Stimulation Research Study
An observational study of Chronic Low Back and Leg Pain, run by MedtronicNeuro at 3 sites in United States.
Trial summary
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy. 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
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2008to Mar 2013
- 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: Candidates for Spinal Cord Stimulation
Who may be able to join
- 18 years of age or older
- Candidate for SCS device trial
- Subject is ambulatory
- Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
- Undergoing treatment for low back pain or low back pain plus leg pain
- Does not have or has not had a previous SCS implant
Show all 9Show fewer
- Willing and able to complete protocol requirements
- Willing and able to sign the study-specific Informed Consent form
- Male or non-pregnant female
Who cannot join
- Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
- Cancer or any other malignant disease
- Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
- A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
- Non-English speaking or an inability to complete questionnaires accurately
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, 55435
Napa Pain Institute
Napa, California, 94558
About this study
Official title: Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
- Conditions
- Chronic Low Back and Leg Pain
- Keywords
- activity, spinal cord stimulation, pain
- Medical subject headings
- Motor Activity, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)
Measured: 4, 12, 24 weeks post implant
Change from Baseline in Posture Parameters (minutes per 24 hours)
Measured: 4, 12, 24 weeks post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2013
- Study completionMar 2013
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 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 Specialists (MAPS)Robert Jamison, Ph.D, Principal investigator, Brigham and Women's HospitalEric Grigsby, M.D., Principal investigator, Napa Pain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768872
- Sponsor's protocol ID
- 1644
- Acronym
- ADR-SCS
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2008
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro Ambulatory Data Recorder (ADR) Spinal Cord Stimulation (SCS) Study
- ClinicalTrials.gov ID
- NCT00768872
- Acronym / sponsor ID
- ADR-SCS / 1644
- Conditions
- Chronic Low Back and Leg Pain
- Keywords
- activity, spinal cord stimulation, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Oct 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 a patient's activity levels before and after spinal cord stimulation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates for Spinal Cord Stimulation
Key inclusion criteria (9 listed)
- 18 years of age or older
- Candidate for SCS device trial
- Subject is ambulatory
- Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
- Undergoing treatment for low back pain or low back pain plus leg pain
Key exclusion criteria (5 listed)
- Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
- Cancer or any other malignant disease
- Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
- A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
- Non-English speaking or an inability to complete questionnaires accurately
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
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds)
Time frame: 4, 12, 24 weeks post implant
Change from Baseline in Posture Parameters (minutes per 24 hours)
Time frame: 4, 12, 24 weeks post implant
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 14 Oct 2016.
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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 (MAPS)
Robert Jamison, Ph.D principal investigator
Brigham and Women's Hospital
Eric Grigsby, M.D. principal investigator
Napa Pain Institute
3 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 3 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 9 inclusion and 5 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds) (time frame: 4, 12, 24 weeks post implant). The study lists 2 primary outcomes in all. 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 14 Oct 2016.