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Clinical Trials/ACTRN12614000236695
ACTRN12614000236695
Not yet recruiting
未知

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 sites17 target enrollmentMarch 5, 2014
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ConditionsChronic lumbar spine painChronic leg painAnaesthesiology - Pain management

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic lumbar spine pain
Sponsor
Dr Simon Tame
Enrollment
17
Status
Not yet recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr Simon Tame

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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).

Outcomes

Primary Outcomes

Not specified

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