Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000236695
Ethics application status
Approved
Date submitted
22/02/2014
Date registered
5/03/2014
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 284151 0
Nil
Universal Trial Number (UTN)
Trial acronym
HFS ONE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lumbar spine pain 291234 0
Chronic leg pain 291259 0
Condition category
Condition code
Anaesthesiology 291579 291579 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288843 0
Treatment: Devices
Intervention code [2] 288844 0
Treatment: Surgery
Comparator / control treatment
Placebo/Sham treatment:

Stimulation parameters:

The stimulation provided during the placebo phase is known to not result in any therapeutic effect. The frequency is set below 1kHz. There are 3 programs developed to shift the stimulation between the T8 and T10 levels (as with the active treatment). The amperage is varied between 1.5mA and 3.5mA by the participant for each program. As with active treatment the most effective program and amperage is reverted to once all programs have been tested for the remainder of the trial period. As with the active treatment period participants are contacted daily by phone (or in the clinic) to guide shifting between programs or changing amperage. As with active treatment the participant has no perception of the stimulation.

Unlike the constant stimulation in the active program, the stimulation during the placebo phase is activated for 1 second every hour only by the external pulse generator.
Control group
Placebo

Outcomes
Primary outcome [1] 291531 0
Lumbar Spine Pain and Leg Pain Numerical Rating Scale (NRS) scores during active treatment and placebo treatment.
Timepoint [1] 291531 0
NRS scores recorded at Day 10 and Day 20. These two timepoints represent the end of the active or placebo trial phase.
Secondary outcome [1] 306980 0
Complications of the procedure.

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:

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.

Rare: Superficial skin infection where the leads exit through the skin (a rate of 4-5% is expected from observational studies).

Very rare: Neurological damage from direct neurological trauma from the needles or leads, bleeding, or deep (spinal) infection.

We will record the rare or very rare complications.
Timepoint [1] 306980 0
The rare or very rare complications that we plan to record will require the trial to be terminated.

The timepoint at which such a complication occurs and is documented will be when it is recorded.

This timepoint could be anywhere from Day 1 to Day 20.

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who are selected as appropriate for treatment are invited to participate. If patients wish to participate the information and consent form is given to them and carefully read with them to ensure understanding. If consent is given for participation the trial proceeds.

After the insertion of the trial device, a designated study coordinator at the central administration site looks at the randomisation sequence (a generated list) and distributes the active or placebo external pulse generators (EPGs) as directed by the randomisation sequence. This designated study coordinator is the only team member who is aware of allocation and allocation is concealed from the rest of the research team.


At the end of the trial after the outcome data is collected and stored, the treating physician and patient are un-blinded and the results are discussed.

The data is stored and analysed by Hunter Medical Research Institute (HMRI) offsite.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
CReDITSS system used to generate a randomisation code with concealed allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics:

Table of baseline characteristics to ensure that randomization has worked properly

Primary endpoints:

Paired t-tests for NRS Back Pain and NRS Leg Pain in each period for overall group and by subgroup (back and leg pain group and back pain only group); the subgroup analysis will count as a secondary analysis.

To verify whether there is an order effect (i.e. different effect on pain whether randomized to placebo first or active program first, a repeated measures ANOVA using 10 and 20 day NRS in each period, with an order term, will be used.

Secondary endpoints:

Chi-sq on percentage adverse events in each period for overall group and by subgroup (back and leg pain group and back pain only group).

To determine if a 50% reduction in NRS Back Pain and NRS Leg Pain is achieved with active treatment a NcNemar’s test will be used. This is effectively a paired chi-squared test to see if the proportion of people meeting the 50% threshold in pain reduction is different between the 2 periods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 7819 0
2290 - Charlestown

Funding & Sponsors
Funding source category [1] 288777 0
Self funded/Unfunded
Name [1] 288777 0
Country [1] 288777 0
Primary sponsor type
Individual
Name
Dr Simon Tame
Address
Specialist Pain Management Physician and Specialist Anaesthetist.
Joint Chief Investigator, HFS ONE study.
Northern Integrated Pain Management.
Suite 3, 20 Smith St Charlestown, NSW, 2290.
Country
Australia
Secondary sponsor category [1] 287475 0
Individual
Name [1] 287475 0
Dr John Prickett
Address [1] 287475 0
Specialist Anaesthetist and Pain Management Consultant
Joint Chief Investigator, HFS ONE study.
Northern Integrated Pain Management.
Suite 3, 20 Smith St Charlestown, NSW, 2290
Country [1] 287475 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290621 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290621 0
Hunter New England
Local Health District, Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 290621 0
Australia
Date submitted for ethics approval [1] 290621 0
Approval date [1] 290621 0
27/02/2014
Ethics approval number [1] 290621 0
EC00403

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46470 0
Dr Simon Tame
Address 46470 0
Northern Integrated Pain Management
Suite 3, 20 Smith St Charlestown. NSW, 2290.
Country 46470 0
Australia
Phone 46470 0
61-2-49238900
Fax 46470 0
61-2-49478991
Email 46470 0
simon@nipm.com.au
Contact person for public queries
Name 46471 0
Mrs Kristy MacIntosh
Address 46471 0
Practice Manager
Northern Integrated Pain Management
Suite 3, 20 Smith St Charlestown. NSW, 2290.
Country 46471 0
Australia
Phone 46471 0
61-2-49238900
Fax 46471 0
61-2-49478991
Email 46471 0
admin@nipm.com.au
Contact person for scientific queries
Name 46472 0
Dr Simon Tame
Address 46472 0
Joint Chief Investigator, HFS ONE
Northern Integrated Pain Management
Suite 3, 20 Smith St Charlestown. NSW, 2290.
Country 46472 0
Australia
Phone 46472 0
61-2-49238900
Fax 46472 0
61-2-49478991
Email 46472 0
simon@nipm.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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