Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction

Completed

Conditions studied: Sacroiliac Joint Dysfunction

In brief

Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or sham. At six weeks follow up they will be unblinded; sham subjects will then be given option to receive treatment. Subjects will be followed after procedure for data collection for economic outcomes and efficacy of treatment.

Key facts

Study ID

NCT01104051

Run by

Coastal Orthopedics & Sports Medicine

People needed

28

Starts

2010-04-01

Expected to finish

2015-06-01

Last updated by the study team

2015-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. 18 years old, or older 2. Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale 3. Tenderness over the SI joint 4. 75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A) 5. Stable medications for pain for the last seven days 6. Have used at least 3 alternative treatments for pain without success (se 7. BMI less than 35.0

You may not qualify if…

• Focal Neurologic Signs
• Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks
• Previous radiofrequency procedure within the last 6 months
• Moderate or greater spinal stenosis
• Greater than Grade 2 listhesis
• Foraminal Stenosis; marked to severe
• Previous Lumbar Spine Surgery
• Unstable Medical or Psychological Conditions as determined by the investigator
• Concomitant cervical or thoracic pain greater than 2/10 on VAS
• Workers compensation, disability or litigation
• Pregnancy, breast feeding or planning on becoming pregnant during the trial
• Subject unwillingness to complete study related activities
• Current Smoker; unless quit greater than 6 months -

Where it is running

• Coastal Orthopedics & Sports Medicine — Bradenton, Florida, United States

Full record on ClinicalTrials.gov

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