Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction
CompletedNCT01104051
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Prospective, Single Center, Double Blind, Randomized, Sham Controlled, Crossover Study to Evaluate the Clinical Efficacy of Radiofrequency Nerve Ablation Using Simplicity III Versus Sham for the Treatment of Chronic Low Back Pain Associated With Sacroiliac Joint Dysfunction
- Conditions
- Sacroiliac Joint Dysfunction
- Sponsor
- Coastal Orthopedics & Sports Medicine
- Start date
- 2010-04
- Primary completion
- 2015-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: 1. Focal Neurologic Signs 2. 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 3. Previous radiofrequency procedure within the last 6 months 4. Moderate or greater spinal stenosis 5. Greater than Grade 2 listhesis 6. Foraminal Stenosis; marked to severe 7. Previous Lumbar Spine Surgery 8. Unstable Medical or Psychological Conditions as determined by the investigator 9. Concomitant cervical or thoracic pain greater than 2/10 on VAS 10. Workers compensation, disability or litigation 11. Pregnancy, breast feeding or planning on becoming pregnant during the trial 12. Subject unwillingness to complete study related activities 13. Current Smoker; unless quit greater than 6 months -
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01104051