Chronic Pain
Conditions
Keywords
spinal cord stimulation, automatic control
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.
Interventions
DEVICESaluda Medical External Trial System
Sponsors
Saluda Medical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events as a Measure of Safety | 20 days | — |
| Compare change from baseline of pain scores between automatic and manual control stimulation | 20 days | 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 | 20 days | 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 | 20 days | — |
Countries
United States
Outcome results
None listed