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CLINICAL TRIAL
JOURNAL ARTICLE
Single level lumbar disc herniations resulting in radicular pain: pain and functional outcomes after treatment with targeted disc decompression.
Pain Medicine 2008 October
STUDY DESIGN: Single-arm prospective clinical trial.
OBJECTIVE: To determine the treatment effect and MRI changes of targeted disc decompression using an intradiscal catheter for focal heating of symptomatic lumbar disc protrusions resulting in radicular pain.
SUMMARY OF BACKGROUND DATA: Percutaneous methods for treatment of lumbar disc herniations are potentially attractive alternatives to open surgical discetomies. The effects of a newly designed, percutaneous electrothermal intradiscal catheter were evaluated.
METHODS: Twenty-two subjects with MRI confirmed, single-level contained lumbar disc protrusions, a minimum of 8 weeks of radicular pain (average 63 weeks) and failed nonsurgical treatment were invited. Nineteen patients underwent the decompression procedure. Follow-up was performed by physical exam and pain severity visual analog scale (VAS), SF-36 bodily pain (BP)/physical functioning (PF) scores for 12 months post-procedure. MRIs were obtained prior to treatment and at 3 months post-procedure.
RESULTS: Eighty-four percent of treated patients were available for follow-up at 12 months. The mean reduction in leg pain VAS scores was 2.6 points (40.6%, 95% CI 1.0-4.1). The mean reduction in back pain VAS scores was 2.4 points (44.4%, 95% CI 0.8-4.0). SF-36 BP scores improved 28.8 points (95% CI 17.5-40.0) and SF-36 PF scores improved 25.4 points (95% CI 13.0-37.7) on average. Effect sizes were small for VAS scores and moderate for SF-36 scores. Fifty-four percent of disc herniations were improved or resolved on MRI. No device-related or intraoperative complications were observed.
CONCLUSIONS: Targeted disc decompression provided moderate improvement in leg pain and function in the majority of patients with chronic radicular pain.
OBJECTIVE: To determine the treatment effect and MRI changes of targeted disc decompression using an intradiscal catheter for focal heating of symptomatic lumbar disc protrusions resulting in radicular pain.
SUMMARY OF BACKGROUND DATA: Percutaneous methods for treatment of lumbar disc herniations are potentially attractive alternatives to open surgical discetomies. The effects of a newly designed, percutaneous electrothermal intradiscal catheter were evaluated.
METHODS: Twenty-two subjects with MRI confirmed, single-level contained lumbar disc protrusions, a minimum of 8 weeks of radicular pain (average 63 weeks) and failed nonsurgical treatment were invited. Nineteen patients underwent the decompression procedure. Follow-up was performed by physical exam and pain severity visual analog scale (VAS), SF-36 bodily pain (BP)/physical functioning (PF) scores for 12 months post-procedure. MRIs were obtained prior to treatment and at 3 months post-procedure.
RESULTS: Eighty-four percent of treated patients were available for follow-up at 12 months. The mean reduction in leg pain VAS scores was 2.6 points (40.6%, 95% CI 1.0-4.1). The mean reduction in back pain VAS scores was 2.4 points (44.4%, 95% CI 0.8-4.0). SF-36 BP scores improved 28.8 points (95% CI 17.5-40.0) and SF-36 PF scores improved 25.4 points (95% CI 13.0-37.7) on average. Effect sizes were small for VAS scores and moderate for SF-36 scores. Fifty-four percent of disc herniations were improved or resolved on MRI. No device-related or intraoperative complications were observed.
CONCLUSIONS: Targeted disc decompression provided moderate improvement in leg pain and function in the majority of patients with chronic radicular pain.
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