Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain

Inclusion Criteria:

- Predominantly axial pain below the L5 vertebrae

- >75% pain relief from 2 separate lateral branch blocks done on different days
(followed by return to baseline pain)

- Chronic axial pain lasting for longer than six months: 3 day average VAS between 4
and 8.

- Age greater than 18 years.

- Failed to achieve adequate improvement with comprehensive non-operative treatments,
including but not limited to: activity alteration, non-steroidal anti-inflammatory,
physical and/or manual therapy, and fluoroscopically guided steroid injections in and
around the area of pathology.

- All other possible sources of low back pain have been ruled out, including but not
limited to: the intervertebral discs, bone fracture, the zygapophyseal joints, the
hip joint, symptomatic spondylolisthesis, tumor and other regional soft tissue
structures (this is done by physical exam, medical history, and MRI/CT/X-ray as
required)

Exclusion Criteria:

- Beck Depression Score >20 or irreversible psychological barriers to recovery

- Spinal pathology that may impede recovery such as spina bifida occulta,
spondylolisthesis at L5/S1, or scoliosis.

- Moderate or severe foraminal or central canal stenosis

- Systemic infection or localized infection at anticipated introducer entry site.

- Concomitant cervical or thoracic pain greater than 2/10 on a VAS

- Uncontrolled or acute illness

- Chronic severe conditions such as rheumatoid/inflammatory arthritis

- Pregnancy

- Active radicular pain

- Immunosuppression (eg. AIDS, cancer, diabetes, surgery <3 months ago)

- Worker's compensation, injury litigation, or disability remuneration

- Allergy to injectants or medications used in procedure

- High narcotics use (>30 mg hydrocodone or equivalent)

- Patients who smoke. Termination for at least 6 months and no smoking during follow up
period are acceptable with caution.

- Body Mass Index greater than 29.9 (obese).

- Subject unwilling to consent to the study