Sacroiliac Joint Dysfunction Clinical Trial
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
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.
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.
;
Observational Model: Case-Crossover, Time Perspective: Prospective
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