Chronic PainPanoramaNCT02161627
Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial
A study testing Saluda Medical External Trial System in people with Chronic Pain, run by Saluda Medical Pty Ltd at 10 sites in United States.
Trial summary
The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Saluda Medical External Trial System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2014to May 2015
- Phase
- Interventional
- 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
- Patients enrolled in this study must meet the following inclusion criteria:
- Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5), which has been refractory to conservative therapy for a minimum of 3 months.
- Have been approved to undergo a trial of SCS.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
- Be 18 years of age or older at the time of enrollment
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- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and visits
- Females of childbearing age must have a negative urine pregnancy test at baseline
Who cannot join
- Patients enrolled in this study must not meet the following exclusion criteria:
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
- Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- Have a diagnosis of scoliosis that precludes lead placement
- Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
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- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- Have a condition currently requiring or likely to require the use of MRI or diathermy
- Have pain due to a malignant disease
- Have a life expectancy of less than 1 year
- Have an active systemic or local infection
- Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
- Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
- Be concomitantly participating in another clinical study
- Be involved in an injury claim under current litigation
- Have a pending or approved worker's compensation claim
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
St Luke's Hospital, Neurosurgical Associates
Bethlehem, Pennsylvania, 18015
Performance Spine & Sports Physicians
East Norriton, Pennsylvania, 19403
Fox Chase Pain Management
Feasterville-Trevose, Pennsylvania, 19053
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
The Pain Center of Arizona
Phoenix, Arizona, 85027
Arizona Pain Specialists
Scottsdale, Arizona, 85258
Premier Pain Management
Shrewsbury, New Jersey, 07702
University Pain Management Center
Somerset, New Jersey, 08873
Center for Neurosciences
Tucson, Arizona, 85718
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Prospective, Multicenter, Randomized Double-blind Crossover Study Examining the Safety and Effectiveness of Spinal Cord Stimulation Incorporating Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs in an Extended Trial
The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
Read the detailed description
Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.
- Conditions
- Chronic Pain
- Being tested
- Saluda Medical External Trial System
- Keywords
- spinal cord stimulation, automatic control
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saluda Medical External Trial SystemDevice
Saluda Medical External Trial SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Automatic Control | Experimental | Automatic Control using Saluda Medical External Trial System Receives: Device: Saluda Medical External Trial System |
| Manual Control | Active comparator | Manual Control using Saluda Medical External Trial System Receives: Device: Saluda Medical External Trial System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome.
Measured: 20 days
Secondary outcomes (4)
Number of Adverse Events as a Measure of Safety
Measured: 20 days
Compare change from baseline of pain scores between automatic and manual control stimulation
Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study
Measured: 20 days
Compare change from baseline of quality of life scores, between automatic and manual control stimulation
Quality of life scores are obtained from the Short Form - 36 (SF-36), and EuroQol-5D-5L questionnaires administered at baseline and after each arm of the study
Measured: 20 days
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saluda Medical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Cousins, MD DSc, Principal investigator, Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore HospitalAshwini Sharan, MD, Principal investigator, Department of Neurosurgery, Thomas Jefferson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161627
- Sponsor's protocol ID
- SBWSH1302
- Other IDs
- U1111-1157-5143
- Acronym
- Panorama
- Status last verified
- Sep 2016
- First submitted
- 6 Jun 2014
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Double-blind Crossover Study Examining the Safety and Effectiveness of Spinal Cord Stimulation Incorporating Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs in an Extended Trial
- ClinicalTrials.gov ID
- NCT02161627
- Acronym / sponsor ID
- Panorama / SBWSH1302
- Conditions
- Chronic Pain
- Keywords
- spinal cord stimulation, automatic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jun 2014 (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 aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
Detailed description
Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic Control | Experimental | Device: Saluda Medical External Trial SystemAutomatic Control using Saluda Medical External Trial System |
| Manual Control | Active comparator | Device: Saluda Medical External Trial SystemManual Control using Saluda Medical External Trial System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been diagnosed with chronic, intractable pain of the trunk and/or limbs (VAS ≥ 5), which has been refractory to conservative therapy for a minimum of 3 months.
- Have been approved to undergo a trial of SCS.
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
- Be 18 years of age or older at the time of enrollment
Key exclusion criteria (17 listed)
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
- Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- Have a diagnosis of scoliosis that precludes lead placement
- Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
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 |
|---|---|---|
| Saluda Medical External Trial System | Device | Automatic Control |
| Saluda Medical External Trial System | Device | Manual Control |
Primary outcome
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
Time frame: 20 days
After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome.
4 secondary outcomes
Number of Adverse Events as a Measure of Safety
Time frame: 20 days
Compare change from baseline of pain scores between automatic and manual control stimulation
Time frame: 20 days
Compare change from baseline of quality of life scores, between automatic and manual control stimulation
Time frame: 20 days
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
Time frame: 20 days
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 3 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.
Michael J Cousins, MD DSc principal investigator
Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital
Ashwini Sharan, MD principal investigator
Department of Neurosurgery, Thomas Jefferson University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saluda Medical External Trial System in people with Chronic Pain, run by Saluda Medical Pty Ltd at 10 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 17 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 3 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 10 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?
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm (time frame: 20 days). 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 3 Oct 2016.