Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01104051
Brief 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.
Study:
NCT01104051
Study Brief:
Protocol Section:
NCT01104051