Chronic Refractory Low Back and Leg PainRestoreSensorNCT01874899
Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
An observational study of Chronic Refractory Low Back and Leg Pain, run by Justin Parker Neurological Institute at 1 site in United States.
Trial summary
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Refractory Low Back and Leg Pain
- What is being tested?
- RestoreSensor Neurostimulation
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2017
- How long will I take part?
- 6 Months
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with chronic refractory back and leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions.
Who may be able to join
- Skeletally mature adults between 18 and 70 years old
- Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
- > 50% pain reduction during the trail period
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing to sign a study specific informed consent
Who cannot join
- Previous SCS treatment
- Surgically remediable spinal condition
- Active local or systemic infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Neurosurgical Associates
Boulder, Colorado, 80302
About this study
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
Read the detailed description
A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.
- Conditions
- Chronic Refractory Low Back and Leg Pain
- Being tested
- RestoreSensor Neurostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestoreSensor NeurostimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Manual, then Automatic Stimulation | The RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months Receives: Device: RestoreSensor Neurostimulation | |
| Automatic, then Manual Stimulation | The RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months. Receives: Device: RestoreSensor Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation amplitude changes in response to postural changes
Threshold and therapeutic stimulation parameters in different postures: lying right, lying left, lying prone, lying supine, upright and upright active will be collected for manual and sensor-driven position-adaptive stimulation.
Measured: 6 months
Secondary outcomes (1)
Sleep quality improvement
Pittsburg Sleep Quality Index Oswestry Disability Index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Refractory 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 crossover
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Justin Parker Neurological Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan T. Villavicencio, MD, Justin Parker Neurological Institute
- Investigators
- Kara Beasley, DO, Principal investigator, Boulder Neurosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874899
- Sponsor's protocol ID
- JPNI-3
- Acronym
- RestoreSensor
- Status last verified
- Aug 2019
- First submitted
- 6 Jun 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Feasibility Study Comparing Manual vs. Automatic Position-Adaptive Spinal Cord Stimulation With Surgical Leads
- ClinicalTrials.gov ID
- NCT01874899
- Acronym / sponsor ID
- RestoreSensor / JPNI-3
- Conditions
- Chronic Refractory Low Back and Leg Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Justin Parker Neurological InstituteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Jun 2013 (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 main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
Detailed description
A single-center, prospective, randomized study with a two-arm crossover design. The primary objective of this study is to establish threshold and therapeutic stimulation parameters for the RestoreSensor neurostimulator in response to postural changes. The secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual, then Automatic Stimulation | – | Device: RestoreSensor NeurostimulationThe RestoreSensor neurostimulator will be programed for manual stimulation adjustments and the patients will crossover to automatic stimulation group after 1.5 months |
| Automatic, then Manual Stimulation | – | Device: RestoreSensor NeurostimulationThe RestoreSensor neurostimulator will be programed for automatic stimulation adjustments and the patients will crossover to manual stimulation group after 1.5 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic refractory back and leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions.
Key inclusion criteria (5 listed)
- Skeletally mature adults between 18 and 70 years old
- Patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions
- > 50% pain reduction during the trail period
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing to sign a study specific informed consent
Key exclusion criteria (3 listed)
- Previous SCS treatment
- Surgically remediable spinal condition
- Active local or systemic infection
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 |
|---|---|---|
| RestoreSensor Neurostimulation | Device | Automatic, then Manual Stimulation, Manual, then Automatic Stimulation |
Primary outcome
Stimulation amplitude changes in response to postural changes
Time frame: 6 months
Threshold and therapeutic stimulation parameters in different postures: lying right, lying left, lying prone, lying supine, upright and upright active will be collected for manual and sensor-driven position-adaptive stimulation.
1 secondary outcome
Sleep quality improvement
Time frame: 6 months
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 7 Aug 2019.
Related trials for Chronic Refractory Low Back and Leg Pain
Recruiting
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Chronic Pain, Intractable Pain
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.
Kara Beasley, DO principal investigator
Boulder Neurosurgical Associates
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 Chronic Refractory Low Back and Leg Pain, run by Justin Parker Neurological Institute 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 5 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 7 Aug 2019. 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 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?
Stimulation amplitude changes in response to postural changes (time frame: 6 months). 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 7 Aug 2019.