Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Saluda Medical External Trial System
* Device: Saluda Medical External Trial System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automatic Control<br>Automatic Control using Saluda Medical External Trial System | Device: Saluda Medical External Trial System<br> <br> |
| Active Comparator: Manual Control<br>Manual Control using Saluda Medical External Trial System | Device: Saluda Medical External Trial System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events as a Measure of Safety |  | 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 | 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 | 20 days | 
| Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation |  | 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation, automatic control