A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain

Inclusion Criteria:

1. Subject is male or female between the ages of 22 and 75 years

2. Subject is able and willing to comply with the follow-up schedule and protocol

3. Subject has chronic, intractable pain of the lower limb(s) for at least 6 months

4. Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral
causalgia

5. Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in
the area of greatest pain in the lower limbs.

6. Subject has failed to achieve adequate pain relief from at least 2 prior
pharmacologic treatments from at least 2 different drugs classes

7. Subject has had stable neurologic function in the past 30 days

8. In the opinion of the Investigator, the subject is psychologically appropriate for
the implantation of an active implantable medical device

9. Subject is able to provide written informed consent

Exclusion Criteria:

1. Back pain is the greatest region of pain as measured on the baseline VAS.

2. Female subject of childbearing potential is pregnant/nursing, plans to become
pregnant or is unwilling to use approved birth control

3. Subject has exhibited escalating or changing pain condition within the past 30 days
as evidenced by Investigator examination

4. Subject is currently involved in medically related litigation, including workers
compensation

5. Subject has had corticosteroid therapy at an intended site of stimulation within the
past 30 days

6. Subject's pain medication(s) dosage(s) are not stable for at least 30 days

7. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion
within the past 3 months

8. Subject has previously failed spinal cord stimulation therapy

9. Subject currently has an active implantable device including implantable cardioverter
defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject
requires magnetic resonance imaging (MRIs) or diathermy

10. Subject has pain only within a cervical distribution

11. Subject has cognitive, physical or sensory impairment that, in the opinion of the
Investigator, may limit their ability to operate the device

12. Subject currently has an indwelling device that may pose an increased risk of
infection

13. Subject currently has an active systemic infection.

14. Subject has, in the opinion of the investigator, a medical comorbidity that
contraindicates placement of an active medical device

15. Subject has participated in another clinical investigation within 30 days

16. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the
Investigator, precludes participation

17. Subject has been diagnosed with cancer in the past 2 years

18. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the
Investigator's opinion, contraindicates lead placement

19. Subject is a prisoner