NCT01104051

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Coastal Orthopedics & Sports Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments: * Pharmacologic Management * Therapies; physical, acupuncture, massage etc… * Other alternative treatments Enrollment, Treatment/Sham Procedure, Follow-up at 3 weeks, 6 weeks with unblinding, 4, 6, 9 months. Un-blinding occurring at 6 weeks with crossover option to receive treatment. Total visits 7 with enrollment approximately over a period of 9 months. Trial extension optional for phone contact at year 1, 2. Sham subjects receiving treatment will be followed at months 6 weeks, 4, and 6 months with phone calls at year 1, 2. Patients who complete at least 50% of their patient diaries, and miss no more 2 consecutive office visits. Data will be used if patients have remained enrolled thru 4 month visit.

Conditions

• Sacroiliac Joint Dysfunction

Timeline

• Start date: 2010-04-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-04-15
• Last updated: 2015-07-29

Locations

1 site across 1 country: United States