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

Launched by BAYLIS MEDICAL COMPANY · Jul 7, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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