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

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.

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