Neuropathic PainNCT03249922
Quality of Life Outcomes in Spinal Cord Stimulation
An observational study of Neuropathic Pain and Low Back Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuropathic Pain, Low Back Pain
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 22 Jul 2018
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients of the functional neurosurgery and neuromodulation department at New Jersey Medical School who present for indicated spinal cord stimulation therapy.
Who may be able to join
- Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.
- Ages 18-90 with no ethnicity or gender predilections.
Who cannot join
- Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurologic Institute of New Jersey
Newark, New Jersey, 07103
About this study
Official title: A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.
Read the detailed description
This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.
- Conditions
- Neuropathic Pain, Low Back Pain
- Being tested
- Spinal Cord Stimulation
- Keywords
- spinal cord stimulation
- Medical subject headings
- Neuralgia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | All patients who are considered candidates for spinal cord stimulator implant will be assigned to the "Treatment Group". Participiants will be clinically evaluated and given the Owenstry low back disability index, WHODAS 12, Beck depression index and SF-36. Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with at least 50% improvement in VAS Pain Score
The number of patients who had at least 50% improvement in VAS pain score
Measured: 12 Months
The number of patients with at least 50% improvement in Owenstry low back disability index
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
Measured: 12 Months
The number of patients with at least 50% improvement in WHODAS 12 disability index.
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
Measured: 12 Months
Secondary outcomes (2)
The number of patients with at least 50% improvement in SF-36 quality of life score
The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire.
Measured: 12 months
The number of patients with at least 50% improvement in beck depression inventory
The number of patients who had at least 50% improvement in depression as determined by this questionnaire.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Oct 2017
- Primary completion22 Jul 2018
- Study completion22 Jul 2018
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonios Mammis MD, Rutgers, The State University of New Jersey
- Investigators
- Antonios Mammis, MD, Principal investigator, mammisan@njms.rutgers.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249922
- Sponsor's protocol ID
- Pro20170000766
- Status last verified
- Jul 2018
- First submitted
- 11 Aug 2017
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT03249922
- Acronym / sponsor ID
- Pro20170000766
- Conditions
- Neuropathic Pain, Low Back Pain
- Keywords
- spinal cord stimulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 22 Jul 2018 (actual)
- First posted
- 15 Aug 2017 (actual)
- 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 investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.
Detailed description
This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Spinal Cord StimulationAll patients who are considered candidates for spinal cord stimulator implant will be assigned to the "Treatment Group". Participiants will be clinically evaluated and given the Owenstry low back disability index, WHODAS 12, Beck depression index and SF-36. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of the functional neurosurgery and neuromodulation department at New Jersey Medical School who present for indicated spinal cord stimulation therapy.
Key inclusion criteria (2 listed)
- Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.
- Ages 18-90 with no ethnicity or gender predilections.
Key exclusion criteria (1 listed)
- Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.
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 |
|---|---|---|
| Spinal Cord StimulationImplantation of a spinal cord stimulator for the control of axial back or neuropathic pain. | Device | Treatment Group |
Primary outcome
The number of patients with at least 50% improvement in VAS Pain Score
Time frame: 12 Months
The number of patients who had at least 50% improvement in VAS pain score
The number of patients with at least 50% improvement in Owenstry low back disability index
Time frame: 12 Months
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
The number of patients with at least 50% improvement in WHODAS 12 disability index.
Time frame: 12 Months
The number of patients who had at least 50% improvement in disability as determined by this questionnaire.
2 secondary outcomes
The number of patients with at least 50% improvement in SF-36 quality of life score
Time frame: 12 months
The number of patients with at least 50% improvement in beck depression inventory
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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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.
Antonios Mammis, MD principal investigator
mammisan@njms.rutgers.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Low Back Pain, run by Rutgers, The State University of New Jersey 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 2 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: stopped early, as of the sponsor's last update on 24 Jul 2018. 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?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
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?
The number of patients with at least 50% improvement in VAS Pain Score (time frame: 12 Months). The study lists 3 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 24 Jul 2018.