Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction
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.
Sacroiliac Joint Dysfunction
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|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|
- Reduction in pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]• To evaluate the clinical efficacy of RF lesioning of sensory innervation of the sacroiliac region as a long term treatment for pain associated with SI joint dysfunction as measured by the reduction in VAS scale and the use of pain alleviating therapies
- Economic outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]• To evaluate the economic and cost benefits of radiofrequency as a treatment for chronic pain associated with SI joint pain.
|Study Start Date:||April 2010|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.
subjects to be blinded,to receive sham procedure; The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104051
|United States, Florida|
|Coastal Orthopedics & Sports Medicine|
|Bradenton, Florida, United States, 34209|
|Principal Investigator:||Richard Bundschu, MD||Coastal Orthopedics|