Lateral Branch Cooled Radiofrequency Denervation vs. Conservative Therapy for Sacroiliac Joint Pain

This is an interventional treatment trial for Sacroiliac Joint Pain focused on measuring Back Pain, Low Back Pain, Sacroiliac Back Pain Read More

Inclusion Criteria:

1. Age greater than or equal to 21 years.
2. Able to understand the informed consent, and able to complete outcome measures.
3. Sacroiliac joint (SIJ) pain that is refractory to standard of care treatments such as non-steroidal anti-inflammatory drugs (NSAIDS), physical therapy, etc.
4. At least one positive SIJ pain provocation test (Distraction, Gaenslen's, FABER, Sacral Sulcus tenderness, thigh thrust, compression or sacral thrust).
5. Back pain is predominantly below the lumbar (L) 5 vertebrae.
6. Chronic low back pain lasting for longer than three months.
7. Greater than 50% pain relief lasting for the expected duration of anesthetic or medication from a therapeutic or diagnostic SIJ injection.
8. Greater than 50% pain relief lasting the duration of anesthetic from lateral branch block (done on different days than SIJ injection).
9. Stabilized on pain medication regimen for > 2 months, as defined by a < 10% change in dosage.
10. Numeric rating scale indicating an average pain score of > 4 over the last seven days. (returned to pre-lateral branch block baseline pain).
11. All other possible sources of low back pain have been ruled out as the primary pain generator, including, but not limited to: suspected advanced degenerative joint disease, 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 magnetic resonance imaging/computed tomography/X-ray, as required).
12. Willing to utilize double barrier contraceptive method, if of child-bearing potential.
13. Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
14. Physician believes ablation of the SIJ is an appropriate treatment for the patient.

Exclusion Criteria:

1. Poorly controlled severe psychiatric illness or ongoing psychological barriers to recovery, as determined by the treating physician.
2. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at vertebrae L5/sacroiliac (S) 1, or scoliosis.
3. Symptomatic moderate or severe foraminal or central canal stenosis.
4. Systemic infection or localized infection at anticipated introducer entry site.
5. Uncontrolled immunosuppression (e.g., acquired immune deficiency syndrome (AIDS), cancer, diabetes, etc.)
6. Chronic severe conditions such as rheumatoid/inflammatory arthritis.
7. Pregnancy or recent delivery (within three months).
8. Active radiculopathy pain from lumbar spine.
9. Active hip pathology.
10. Major surgery within three months prior to signing informed consent.
11. Prior radiofrequency denervation of the lateral sacral nerves.
12. Ongoing/unresolved worker's compensation, injury litigation, military medical board, or disability remuneration claims.
13. Allergy to injected substances or medications used in procedure.
14. Body mass index (BMI) > 40 kilograms/meter (squared).
15. Current prescribed opioid medications equivalent to 90 mg of morphine per 24 hours or greater.
16. Subject is currently implanted with pacemaker, stimulator, or defibrillator.
17. Participation in another clinical trial/investigation that could interfere with this trial 30 days prior to signing informed consent.
18. Subject is unwilling or unable to comply with the protocol requirements.