Study of PM Modulation Therapy in Trial Phase

Inclusion Criteria:

1. Capable of giving written informed consent to participate in this clinical study based
on voluntary agreement after a thorough explanation of the patient's participation is
provided to them.

2. Chronic intractable pain of the lower back equal to or greater than pain in lower
limbs, and that has been refractory to conservative therapy for ≥ 3 months.

3. Must be older than 18 years old.

4. Average back pain intensity of ≥ 5 out of 10 on the numerical pain rating scale
(NPRS).

5. Appropriate candidate for spinal cord stimulation trial.

6. Subjects must be on a stable dose of pain medication regimen for at least 1 month.

7. Female patients who are not pregnant and do not plan to become pregnant during the
study. Females of child bearing potential must provide a negative pregnancy test and
must be using reliable contraception and must continue to use reliable contraception
until study completion. Non-childbearing potential is defined as postmenopausal for at
least 2 years or surgical sterilization or hysterectomy at least 3 months before study
start. Patients who become pregnant or who have a spouse/significant other that
becomes pregnant during the course of this study agree to report pregnancy to the
study physician/staff.

8. Must be able to comply with the requirement of study visits and follow-up and phone
visits.

9. Have cognitive ability of operate the remote control and follow therapy instructions
and directions by clinicians.

Exclusion Criteria:

1. Systemic infection.

2. Any active implanted device.

3. Previous experience with SCS therapy either during a trial or fully implanted

4. Evidence of serious neurological, psychological or psychiatric disorders.

5. Mechanical spinal instability.

6. Patients with uncorrected coagulation disorders or who are on anticoagulation therapy
and cannot interrupt the therapy.

7. Patient who are pregnant, breast-feeding or women of childbearing potential with
positive pregnancy tests.

8. Human immunodeficiency virus (HIV) infection or a clinically significant infection.

9. Patients who are undergoing or will undergo therapies or diagnostics that involve
electromagnetic fields such as: diathermy based therapies, electrocautery, magnetic
resonance imaging (MRI), radiofrequency (RF) or microwave ablation, bone growth
stimulators, electrolysis, therapeutic ultrasound, ultrasound, lithotripsy,
psychotherapeutic procedures, radiation therapy, and transcutaneous electrical nerve
stimulation.

10. A clinically significant disorder such as cerebrovascular disease, pulmonary
infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or
congestive heart failure or any other as determined by the investigator.

11. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.

12. Patients who have evidence of major psychiatric disease, mental disorder, drug
dependency, alcohol dependency, or substance abuse disorders.

13. Patients who have progressive neurological disease such as multiple sclerosis, chronic
inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute
herniated disc, or any other as determined by investigator.

14. Medical condition or pain in other body areas that could interfere with study
procedures, accurate pain reporting, and/or confound evaluation of study end points.

15. Concurrent participation in another clinical study.

16. Involvement in an injury claim under current litigation or a pending or approved
workers' compensation claim.