Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000239369
Ethics application status
Approved
Date submitted
6/02/2017
Date registered
16/02/2017
Date last updated
16/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of spinal cord stimulation on nerve function in low back pain
Scientific title
The long-term effects of spinal cord stimulation on neural function in chronic low back pain – a pilot study
Secondary ID [1] 290747 0
Nil known.
Universal Trial Number (UTN)
U1111-1190-9161
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower back pain 301334 0
Condition category
Condition code
Musculoskeletal 301087 301087 0 0
Other muscular and skeletal disorders
Neurological 301587 301587 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prior to their enrolment in this study participants will have been assessed as being suitable candidates, as part of their usual medical care, for either a high frequency (10kHz) spinal cord stimulator (SCS) or a low frequency (100Hz) SCS. Assignment to either high frequency SCS or to low frequency SCS occurs as part of a participants usual medical care and does not form part of this trial.
Arm 1: Participants with lower back pain who successfully completed a trial implantation and proceeded to have a low frequency SCS fitted.
Arm 2: Participants with lower back pain who successfully completed a trial implantation and proceeded to have a high frequency SCS fitted.
Participants in Arms 1 and 2 will be enrolled and followed up from approximately two weeks prior to a temporary SCS implantation until a time point 12 months after the implantation of a permanent SCS.
Intervention code [1] 297077 0
Not applicable
Comparator / control treatment
The control group will consist of participants with lower back pain who, as part of their usual medical care, were assessed as being suitable candidates for a trial of either low or high frequency SCS but in whom the trial was unsuccessful and therefore the participants did not proceed to permanent fitment of a spinal cord stimulator.
Participants will be enrolled and followed up from approximately two weeks prior to a temporary SCS implantation until a time point 12 months after the removal of the trial SCS.
Control group
Active

Outcomes
Primary outcome [1] 300977 0
Change in sensitivity to vibratory stimuli when compared to the pre implantation measure.
Vibration sensitivity will be assessed using a standard Rydel-Seiffer tuning fork and also a Medoc VSA-3000 vibrameter.
Timepoint [1] 300977 0
Baseline and twelve months post permanent SCS implantation.
Secondary outcome [1] 331313 0
Change in sensitivity to vibratory stimuli at 2 weeks, 2 months and six months post implantation, when compared to the baseline score.
Vibration sensitivity will be assessed using a standard Rydel-Seiffer tuning fork and also a Medoc VSA-3000 vibrameter.
Timepoint [1] 331313 0
2 weeks, 2 months and 6 months post permanent SCS implantation.

Eligibility
Key inclusion criteria
1. Have a primary diagnosis of chronic low back pain (lumbo-sacral) with or without leg pain.
2. Be a candidate for a commercial spinal cord stimulation system.
3. Have responded inadequately to at least 6 months of conservative treatment (pharmacological, physical therapy +/- spinal injections including radiofrequency lesioning).
4. Pain intensity >= 3/10 (NRS11) over previous month.
5. Patients may have had previous spinal surgery.
6. Patients with a known condition that may potentially result in neuropathy will not be excluded (e.g. diabetes, multiple sclerosis).
7. Patients with a significant neuropathy demonstrated on clinical examination (e.g. reflex depression, focal sensory changes or focal muscle weakness, especially lower limbs) will not be excluded.
8. May have undertaken a cognitive behavioural therapy pain program.
9. Be able to consent.
10. Be 18 years or older at the time of enrolment.
11. Be able to comply with study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have mechanical spinal instability (diagnosed with radiological imaging).
2. Have malignancy with life expectancy <1year.
3. Have a systemic infection.
4. Have other implantable devices.
5. Are participating in another clinical trial.
6. Have unstable major psychiatric comorbidities.
7. Are pregnant/lactating or not using adequate birth control.
8. Have bleeding or coagulopathy issues.
9. Are immunocompromised and at risk of infection.
10. Have uncontrolled insulin-dependent diabetes mellitus despite treatment.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295530 0
Other Collaborative groups
Name [1] 295530 0
Australia and New Zealand College of Anaesthetists
Country [1] 295530 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 294348 0
None
Name [1] 294348 0
Address [1] 294348 0
Country [1] 294348 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296851 0
NSLHD HREC
Ethics committee address [1] 296851 0
Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St leonards, NSW 2065
Ethics committee country [1] 296851 0
Australia
Date submitted for ethics approval [1] 296851 0
30/09/2016
Approval date [1] 296851 0
20/10/2016
Ethics approval number [1] 296851 0
HREC/16/HAWKE/287

Summary
Brief summary
Spinal cord stimulation (SCS) has been employed for the management of chronic pain for over 50 years. Over this time SCS has become a well-established mode of treatment for neuropathic pain. Until recently most success with SCS has been obtained with pain involving the limbs (e.g. CRPS, sciatica, ischaemic limb pain and peripheral neuropathy). Relief of axial back pain has been more difficult to achieve. In response to problems associated with SCS (stimulation variance with body position, MRI lead incompatibility, difficulties covering certain pain sites) a wide range of device options have developed. As a result the number of companies manufacturing implantable spinal cord stimulators continues to increase with each company claiming specific benefits for their device range.
The most dramatic recent change has been the introduction of high frequency (HF) SCS (500 Hz to 10,000 Hz). Early work on HF SCS demonstrated potential benefits on axial back pain. The additional feature of “paraesthesia-free” stimulation to avoid the need for paraesthesias required by the more conventional tonic low frequency (LF) SCS (<100Hz) has made this form of stimulation more attractive. Paraesthesias have the potential for discomfort particularly with changes in position (standing to lying). In 2015, a landmark prospective randomised trial was published (Kapural et al) reporting superiority of HF SCS over LF SCS for axial back pain. While the mechanisms of action for conventional SCS are still being investigated, even less is known about HF stimulation. Given the positive results reported by Kapural et al it is likely that the use of HF SCS will dramatically increase. While no definitive evidence of neural damage has been found on clinical examination concern has been raised in animal studies about the potential for long-term neural changes with HF SCS. In addition certain patient subpopulations may be more vulnerable to stimulation induced changes in neural function particularly those with spinal canal stenosis (personal communication). Given Kapural et al has only recently been published consensus regarding the long-term use of HF SCS in axial low back pain is yet to be reached.
This pilot study will monitor changes in neural function associated with propriety LF (<100Hz) and HF (10kHz) SCS implantation in people with chronic low back pain over twelve months. The project will inform the development of a full-scale trial. The Global Burden of Disease study now ranks low back pain (LBP) as the number one cause of disability in Australasia. Three million Australians now have long-term disability due to chronic LBP, costing more than $14 billion each year.
As a result of a recent successful high profile multi-centre trial HF SCS implantation for chronic LBP is likely to increase. It is crucial therefore to obtain long-term safety data on this treatment to better inform patient selection and future cost benefit analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71162 0
Dr Paul Wrigley
Address 71162 0
Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 71162 0
Australia
Phone 71162 0
+61 2 9926 4958
Fax 71162 0
Email 71162 0
[email protected]
Contact person for public queries
Name 71163 0
Dr Paul Wrigley
Address 71163 0
Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 71163 0
Australia
Phone 71163 0
+61 2 9926 4958
Fax 71163 0
Email 71163 0
[email protected]
Contact person for scientific queries
Name 71164 0
Dr Paul Wrigley
Address 71164 0
Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065
Country 71164 0
Australia
Phone 71164 0
+61 2 9926 4958
Fax 71164 0
Email 71164 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4039Plain language summaryNo A sub study looking at ways of accurately and reli... [More Details]
4642Study results articleYes 03/11/2018 https://onlinelibrary.wiley.com/doi/f... [More Details]

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