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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Neurological

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]

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]

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]

Baseline and twelve months post permanent SCS implantation.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australia and New Zealand College of Anaesthetists

Address [1]

ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSLHD HREC

Ethics committee address [1]

Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St leonards, NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/09/2016

Approval date [1]

20/10/2016

Ethics approval number [1]

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

Dr Paul Wrigley

Address

Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4958

Fax

[email protected]

Contact person for public queries

Name

Paul Wrigley

Address

Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4958

Fax

[email protected]

Contact person for scientific queries

Name

Paul Wrigley

Address

Level 13, Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065

Country

Australia

Phone

+61 2 9926 4958

Fax

[email protected]

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

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		A sub study looking at ways of accurately and reli... [More Details]
Study results article	Yes		03/11/2018 https://onlinelibrary.wiley.com/doi/f... [More Details]

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No additional documents have been identified.

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