Clinical trial NCT02161627: Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: spinal cord stimulation
automatic control
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Patients enrolled in this study must meet the following inclusion criteria:

1. 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.
2. Have been approved to undergo a trial of SCS.
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. 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
5. Be 18 years of age or older at the time of enrollment
6. Be willing and capable of giving informed consent
7. Be willing and able to comply with study-related requirements, procedures, and visits
8. 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:

1. 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
2. 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
3. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
4. Have a diagnosis of scoliosis that precludes lead placement
5. Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
7. Have a condition currently requiring or likely to require the use of MRI or diathermy
8. Have pain due to a malignant disease
9. Have a life expectancy of less than 1 year
10. Have an active systemic or local infection
11. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
12. 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)
13. 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)
14. Be concomitantly participating in another clinical study
15. Be involved in an injury claim under current litigation
16. Have a pending or approved worker's compensation claim

Primary outcomes:
measure: Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm
timeFrame: 20 days
Secondary outcomes:
measure: Number of Adverse Events as a Measure of Safety
timeFrame: 20 days
measure: Compare change from baseline of pain scores between automatic and manual control stimulation
timeFrame: 20 days
measure: Compare change from baseline of quality of life scores, between automatic and manual control stimulation
timeFrame: 20 days
measure: Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation
timeFrame: 20 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Shrewsbury
country: United States
facility: Premier Pain Management
state: New Jersey
city: Somerset
country: United States
facility: University Pain Management Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Bethlehem
country: United States
facility: St Luke's Hospital, Neurosurgical Associates
state: Pennsylvania
city: East Norriton
country: United States
facility: Performance Spine & Sports Physicians
state: Pennsylvania
city: Feasterville-Trevose
country: United States
facility: Fox Chase Pain Management
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital
name: Michael J Cousins, MD DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Thomas Jefferson University Hospital
name: Ashwini Sharan, MD
role: PRINCIPAL_INVESTIGATOR
References: