None listed
Conditions
Brief summary
HFS ONE is a trial designed to help establish whether 10KHz High Frequency Spinal Cord Stimulation devices are more effective than placebo in treating chronic lumbar spinal pain and leg pain. The treatment appears to be very promising and several observational studies report high rates of significant sustained reductions in lumbar spinal pain and leg pain with this device. The device is already being used widely in Australia and is TGA approved for use in spinal pain and leg pain. Our study design enables a comparison of active treatment with placebo with minimal increased risk over and above a routine trial of the device used in normal clinical practice.
Interventions
The trial exposes participants to a 20 day trial High Frequency Spinal Cord Stimulation. 10 days of the trial are active treatment and 10 days are placebo/sham treatment. Participants and the research team are blinded to whether active or placebo treatment is being used at any given time.
Two spinal cord stimulation leads (each with 8 electrodes) are inserted percutaneously at the beginning of the trial under anaesthesia and with X-Ray guidance. The leads are inserted via epidural needles into
The trial exposes participants to a 20 day trial High Frequency Spinal Cord Stimulation. 10 days of the trial are active treatment and 10 days are placebo/sham treatment. Participants and the research team are blinded to whether active or placebo treatment is being used at any given time. Two spinal cord stimulation leads (each with 8 electrodes) are inserted percutaneously at the beginning of the trial under anaesthesia and with X-Ray guidance. The leads are inserted via epidural needles into the posterior epidural space. The 8 electrodes are at the distal end of each lead and anatomically they span approximately 3 vertebral levels between T8 and T10 in the posterior epidural space. This process takes our practitioners 30 minutes on average. The leads exit through the skin and are secured to the skin with a suture and then padded adhesive dressings are used to cover the site. The active treatment: The stimulation is applied constantly throughout the active treatment phase of the trial. Prior to the trial participants are taught how to cycle between the 3 programs and how to vary the amperage between 1.5mA - 3.5mA for each program. The 3 programs represent the stimulation being applied through different electrodes to shift the level of stimulation anatomically between the T8 and T10 levels. Each program requires trialling for an average of 2 days (based on clinical trialling in over 200 patients in observational trials in Australia and Europe). During each program the participant varies the amperage between 1.5mA and 3.5mA. Participants receive daily instruction either by phone (or in the clinic if required) about cycling between programs and altering amperage during each program. The most effective program and amperage is reverted to for the remainder of the trial period once it is identified. The stimulation parameters are as follows: 10kHz frequency is held constant. Amperage varies between 1.5mA and 3.5mA as selected by the participant. The voltage level is automatically varied by the external pulse generator (EPG) to keep the current constant. The electrical energy generated by these stimulation parameters has no known adverse effects in animal and human studies. The energy generated is insufficient to generate action potentials in sensory or motor nerves which means participants do not feel the active stimulation. Washout period: The washout period from active treatment is normally immediate but some patients report up to 6 hours of persistent analgesia after cessation of stimulation. Very rarely the reported analgesic effect persists for up to 48 hours. The physiological basis of the analgesic effect of High Frequency Spinal Cord Stimulation (HFSCS), and its washout period are unknown. It is speculated that the analgesic effect and the washout analgesia period may represent a placebo phenomenon. Location: Active treatment and sham treatment are both administered at home. Patients are equipped with an external pulse generator (EPG) which generates the therapeutic or sham stimulation. It is a small portable device that is carried in or attached to the belt.
Sponsors
Dr Simon Tame
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
No
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).
Outcome results
None listed