Chronic Pain in the Trunk and LimbsPhase 1NCT00351208
Spinal Cord Stimulation Efficacy Measures
A Phase 1 study testing Medtronic Manufactured Spinal Cord Stimulators in people with Chronic Pain in the Trunk and Limbs, run by New York Neurosurgery & Neuroscience Associates, PLLC at 2 sites in United States.
Trial summary
The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain in the Trunk and Limbs
- What is being tested?
- Medtronic Manufactured Spinal Cord Stimulators
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2006to Aug 2006
- Phase
- Phase 1
- 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
Who may be able to join
- The patient must have SCS implanted for at least 2 months before study start date
- The patient must be at least 18 years old
- The patient must currently be receiving pain relief from SCS usage
- The patient must be willing to participate in a 9-week study
- The patient must have at least 20% of battery life remaining in his/her spinal cord stimulator
- The patient must be able to tolerate Vicodin-Extra Strength as well as Tylenol, but can also take their own pain medication if it is not one of the two mentioned
Who cannot join
- The patient is pregnant or intends to become pregnant during the course of the study.
- The patient by report, and/or by physician assessment, exhibits any or all of the following, which might bias reporting of treatment outcome:
- A strong untreated dependency on prescription medication such as benzodiazepines and narcotic analgesics.
- A strong potential for secondary gain issues.
- A significant, untreated psychiatric comorbidity.
- The patient possesses a coexisting clinically relevant or disabling chronic pain problem not treated by SCS
- The patient has been diagnosed with unstable angina
- The patient receives a Karnofsky's performance score of <60
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
The Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Chandra M Singh, B.S., 718-240-8177, csingh320@gmail.com
Ronit Frenkel, RPA, (516) 255-0350, rfrenkel@nynna.com
- Recruiting
New York Neurosurgery & Neuroscience Associates, PLLC
Rockville Centre, New York, 11570
Ronit Frenkel, RPA, 516-255-0350, rfrenkel@nynna.com
Chandra M Singh, B.S., (718) 240-8177, csingh320@gmail.com
About this study
Official title: The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
The purpose of the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. In this double-blind study, both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week. The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room. While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths. This study hopes to be the first.
Read the detailed description
For a total of 9 weeks, patients will be randomized to 9 stimulation frequency and pulse-width setting combinations. The patient will stay with these settings for a week at a time. Prior to the patient's first office visit, he/she will be asked to take a chest x-ray. The patient will also repeat this chest x-ray at the end of the study. Each patient will be asked to provide daily information regarding pain medication usage, spinal cord stimulation usage, amplitude settings, and pain ratings. Additionally, patients will fill out the Multidimensional Pain Inventory (MPI) and the McGill Pain Questionnaire (MPQ) every Monday when they come to the office, before he/she is randomized to the new settings for the week. The patient will also receive a call from the research assistant to see how he/she is doing that week and the patient will be provided with all the pertinent contact information to call at any time to ask questions. The patient can withdraw from the study completely at any point or drop out of the settings for the week. The patient will have a follow-up visit a month from the study's end date to discuss how the patient has been managing his/her pain at his/her spinal cord stimulator settings. Each patient will be compensated for completing the study. Efficacy will be measured based on the patient's answers to the pain probes, device usage, and medication usage.
- Conditions
- Chronic Pain in the Trunk and Limbs
- Being tested
- Medtronic Manufactured Spinal Cord Stimulators
- Keywords
- Spinal cord stimulation, Spinal cord stimulation efficacy, Spinal cord stimulators, Stimulation frequencies, Stimulation pulse-widths, Varying settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Manufactured Spinal Cord StimulatorsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent pain relief obtained during the one-month follow-up compared to baseline
The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startMay 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Pain in the Trunk and LimbsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- New York Neurosurgery & Neuroscience Associates, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- MedtronicNeuro
- Investigators
- Louis G Cornacchia, MD, Principal investigator, New York Neurosurgery & Neuroscience Associates, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351208
- Sponsor's protocol ID
- 05-20-
- Status last verified
- Jun 2006
- First submitted
- 11 Jul 2006
- Last updated
- 12 Jul 2006
- Results posted
- No
Publications
Mailis-Gagnon A, Furlan AD, Sandoval JA, Taylor R. Spinal cord stimulation for chronic pain. Cochrane Database Syst Rev. 2004;(3):CD003783. doi: 10.1002/14651858.CD003783.pub2.
PubMed 15266501Barbetakis N, Antoniadis T, Tsilikas C. Results of chemical pleurodesis with mitoxantrone in malignant pleural effusion from breast cancer. World J Surg Oncol. 2004 May 20;2:16. doi: 10.1186/1477-7819-2-16.
PubMed 15153245O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Spinal Cord Stimulation at Varying Stimulation Frequencies and Pulse-Widths
- ClinicalTrials.gov ID
- NCT00351208
- Acronym / sponsor ID
- 05-20-
- Conditions
- Chronic Pain in the Trunk and Limbs
- Keywords
- Spinal cord stimulation, Spinal cord stimulation efficacy, Spinal cord stimulators, Stimulation frequencies, Stimulation pulse-widths, Varying settings
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- New York Neurosurgery & Neuroscience Associates, PLLCUniversity, hospital or other
- Collaborators
- MedtronicNeuro
- Study start
- May 2006
- Study completion
- Aug 2006
- First posted
- 12 Jul 2006 (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 the study is to measure the efficacy of varying spinal cord stimulation frequencies and pulse-width settings on chronic pain management. The spinal cord stimulator settings that are most effective in chronic pain management hope to be revealed for the purposes of this study. In this double-blind study, both the patient and the staff will not be aware of the spinal cord stimulator settings for each patient each week. The representative that will set the settings each week will be blinded to the identity of each patient and will set the spinal cord stimulator from another room. While there are few papers that show the efficacy of spinal cord stimulation in treating chronic pain, there has yet to be a study performed that measures the role of stimulation frequency and pulse-widths. This study hopes to be the first.
Detailed description
For a total of 9 weeks, patients will be randomized to 9 stimulation frequency and pulse-width setting combinations. The patient will stay with these settings for a week at a time. Prior to the patient's first office visit, he/she will be asked to take a chest x-ray. The patient will also repeat this chest x-ray at the end of the study. Each patient will be asked to provide daily information regarding pain medication usage, spinal cord stimulation usage, amplitude settings, and pain ratings. Additionally, patients will fill out the Multidimensional Pain Inventory (MPI) and the McGill Pain Questionnaire (MPQ) every Monday when they come to the office, before he/she is randomized to the new settings for the week. The patient will also receive a call from the research assistant to see how he/she is doing that week and the patient will be provided with all the pertinent contact information to call at any time to ask questions. The patient can withdraw from the study completely at any point or drop out of the settings for the week. The patient will have a follow-up visit a month from the study's end date to discuss how the patient has been managing his/her pain at his/her spinal cord stimulator settings. Each patient will be compensated for completing the study. Efficacy will be measured based on the patient's answers to the pain probes, device usage, and medication usage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have SCS implanted for at least 2 months before study start date
- The patient must be at least 18 years old
- The patient must currently be receiving pain relief from SCS usage
- The patient must be willing to participate in a 9-week study
- The patient must have at least 20% of battery life remaining in his/her spinal cord stimulator
Key exclusion criteria (8 listed)
- The patient is pregnant or intends to become pregnant during the course of the study.
- The patient by report, and/or by physician assessment, exhibits any or all of the following, which might bias reporting of treatment outcome:
- A strong untreated dependency on prescription medication such as benzodiazepines and narcotic analgesics.
- A strong potential for secondary gain issues.
- A significant, untreated psychiatric comorbidity.
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 |
|---|---|---|
| Medtronic Manufactured Spinal Cord Stimulators | Device | – |
Primary outcome
Percent pain relief obtained during the one-month follow-up compared to baseline
The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2006.
- Background: PubMed 15266501Mailis-Gagnon A, Furlan AD, Sandoval JA, Taylor R. Spinal cord stimulation for chronic pain. Cochrane Database Syst Rev. 2004;(3):CD003783. doi: 10.1002/14651858.CD003783.pub2.
- Background: PubMed 15153245Barbetakis N, Antoniadis T, Tsilikas C. Results of chemical pleurodesis with mitoxantrone in malignant pleural effusion from breast cancer. World J Surg Oncol. 2004 May 20;2:16. doi: 10.1186/1477-7819-2-16.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
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.
Louis G Cornacchia, MD principal investigator
New York Neurosurgery & Neuroscience Associates, PLLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Medtronic Manufactured Spinal Cord Stimulators in people with Chronic Pain in the Trunk and Limbs, run by New York Neurosurgery & Neuroscience Associates, PLLC 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jul 2006. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chandra M Singh, B.S. ((718) 240-8177, csingh320@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent pain relief obtained during the one-month follow-up compared to baseline. 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?
On the ClinicalTrials.gov record for NCT00351208, which also lists 3 linked publications.
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 12 Jul 2006.