Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial (Panorama)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saluda Medical External Trial System
Saluda Medical External Trial System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring spinal cord stimulation, automatic control
Eligibility Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
- The Pain Center of Arizona
- Arizona Pain Specialists
- Center for Neurosciences
- Premier Pain Management
- University Pain Management Center
- Center for Clinical Research
- St Luke's Hospital, Neurosurgical Associates
- Performance Spine & Sports Physicians
- Fox Chase Pain Management
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Automatic Control
Manual Control
Arm Description
Automatic Control using Saluda Medical External Trial System
Manual Control using Saluda Medical External Trial System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Adverse Events as a Measure of Safety
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
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
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
Full Information
NCT ID
NCT02161627
First Posted
June 6, 2014
Last Updated
September 30, 2016
Sponsor
Saluda Medical Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02161627
Brief Title
Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial
Acronym
Panorama
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saluda Medical Pty Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
spinal cord stimulation, automatic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Automatic Control
Arm Type
Experimental
Arm Description
Automatic Control using Saluda Medical External Trial System
Arm Title
Manual Control
Arm Type
Active Comparator
Arm Description
Manual Control using Saluda Medical External Trial System
Intervention Type
Device
Intervention Name(s)
Saluda Medical External Trial System
Intervention Type
Device
Intervention Name(s)
Saluda Medical External Trial System
Primary Outcome Measure Information:
Title
Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
Description
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.
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Number of Adverse Events as a Measure of Safety
Time Frame
20 days
Title
Compare change from baseline of pain scores between automatic and manual control stimulation
Description
Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study
Time Frame
20 days
Title
Compare change from baseline of quality of life scores, between automatic and manual control stimulation
Description
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
Time Frame
20 days
Title
Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
Time Frame
20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Cousins, MD DSc
Organizational Affiliation
Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashwini Sharan, MD
Organizational Affiliation
Department of Neurosurgery, Thomas Jefferson University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Arizona Pain Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
Premier Pain Management
City
Shrewsbury
State/Province
New Jersey
ZIP/Postal Code
07702
Country
United States
Facility Name
University Pain Management Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
St Luke's Hospital, Neurosurgical Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Performance Spine & Sports Physicians
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Fox Chase Pain Management
City
Feasterville-Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial
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