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

2014-07-23 21:09:33 | BioPortfolio

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.

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Conditions

Sacroiliac Joint Dysfunction

Location

Coastal Orthopedics & Sports Medicine
Bradenton
Florida
United States
34209

Status

Recruiting

Source

Coastal Orthopedics & Sports Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:33-0400

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