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.

Not Applicable

• Conditions: Chronic lumbar spine pain; Chronic leg pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12614000236695
• Lead Sponsor: Dr Simon Tame

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 17

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umbar Spine Pain and Leg Pain Numerical Rating Scale (NRS) scores during active treatment and placebo treatment.[NRS scores recorded at Day 10 and Day 20. These two timepoints represent the end of the active or placebo trial phase.]

Secondary Outcome Measures

Name	Time	Method
Complications of the procedure. <br><br>Specifically this refers to complications related to insertion of the spinal cord stimulation leads. The complications that may occur during or after insertion may include:<br><br>Common: Short lived localised mild to moderate pain. This can last for 2-24 hours after lead insertion. Occasionally the anasethesia can cause mild nausea.<br><br>Rare: Superficial skin infection where the leads exit through the skin (a rate of 4-5% is expected from observational studies).<br><br>Very rare: Neurological damage from direct neurological trauma from the needles or leads, bleeding, or deep (spinal) infection. <br><br>We will record the rare or very rare complications.[The rare or very rare complications that we plan to record will require the trial to be terminated.<br><br>The timepoint at which such a complication occurs and is documented will be when it is recorded.<br><br>This timepoint could be anywhere from Day 1 to Day 20.<br><br>]