HFS ONE: Is high frequency spinal cord stimulation more effective than sham treatment during a 20 day trial period for lumbar spine pain and leg pain? A randomised double-blinded placebo-controlled cross over trial.

Dr Simon Tame0 个研究点目标入组 17 人开始时间: 2014年3月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Persistent Back +/- leg pain for over 6 months
•MRI or CT scan in the last 5 years
•No other treatment available for treating the pain
•Informed consent
•The requirement of having a CT or MRI of the lumbosacral spine in the last 5 years is designed to screen rare situations where lumbar spine surgery may be indicated or likely to be indicated and potentially curative. An example is severe spinal canal stenosis. Leg pain from severe spinal canal stenosis should prompt a surgical assessment and possible surgical decompression in preference to a spinal cord stimulation trial. Another example is high grade spondylolisthesis where both back pain and leg pain can respond well to surgical treatment.

•Spinal surgery is required.
•Contraindication to the procedure such as bleeding or immunological disorder that may increase risk of infection.
•Severe psychological or psychiatric disorder.
•Patients being treated as part of a workers compensation claim (participation in research studies is not permitted).

发起方

Dr Simon Tame