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Trial registered on ANZCTR

Registration number

ACTRN12620000720910

Ethics application status

Approved

Date submitted

18/05/2020

Date registered

2/07/2020

Date last updated

28/09/2022

Date data sharing statement initially provided

2/07/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

An evaluation of spinal cord stimulation for the treatment of chronic pain, also its effect on mood , sleep, physical activity and analgesic medicine requirements.

Scientific title

A double -blind trial of Burst De Ridder (DR) spinal cord stimulation for treating chronic pain.

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic back pain

The effects of pain on sleep quality

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Over a 28 day period patients with a previously implanted Burst DR electical spinal cord stimulator will have their device switched off for two out of eight three to four day cycles . These 'off' periods will not be consecutive and will be determined by a computer randomisation program. Neither the patient or research assistant will know whether the stimulator device is on or off, this is controlled by a technician. Patients will fill out daily questionnaires and pain behaviours will be assessed

Intervention code [1]

Treatment: Devices

Intervention code [2]

Behaviour

Comparator / control treatment

The patients act as their own control as previously implanted Burst DR electrical spinal cord stimulator will be switched on for six out of eight three to four day cycles and off for two cycles.

Control group

Placebo

Outcomes

Primary outcome [1]

Assessment of pain using Brief Pain Inventory

Timepoint [1]

Commencing Baseline (day 1) of study and completed daily until end of study (day 32)

Primary outcome [2]

Assessment of quality of sleep using Sleep Diary

Timepoint [2]

Daily from Baseline (day 1) and completed daily until the end of the study ( day 32)

Primary outcome [3]

Consumption of analgesic medication using daily medication diary

Timepoint [3]

Recorded daily from Baseline ( day 1) until end of study (day 32).

Secondary outcome [1]

Patient mood using the Depression, Anxiety and Stress Scale-21 (DASS-21)

Timepoint [1]

Commencing at Baseline ( day 1 of study) and repeated each visit (days 4,8,11,15,18,22,25,29 and 32)

Secondary outcome [2]

Patient activity using a pedometer

Timepoint [2]

Worn daily from Baseline ( day 1) until end of study (day 32)

Secondary outcome [3]

Assessment of behavioural signs of pain using Pain Behavioural Score

Timepoint [3]

Commenced at Baseline and conducted at every visit ( days 4,8,11,15,18,22,25,29 and 32)

Secondary outcome [4]

Assessment of pressure-pain using a pressure sensor applied at 100 grams/second to the patients forehead until patient reports pain. Patients will also rate sharpness evoked by the 1 second application of a spring-loaded metal pin at a force of 40 grams followed by 5 further applications of the pin with rests of 1 second between each application

Timepoint [4]

Commenced at Baseline and conducted at each visit (days 4,8,11,15,18,22,25,29,and 32)

Secondary outcome [5]

Patient anxiety levels using DASS-21 and Pain Catastrophizing Scale

Timepoint [5]

Commenced at Baseline and conducted at each visit (days 4, 8,11,15,18, 22,25,29 and 32)

Secondary outcome [6]

Patient stress levels using DASS-21 and Pain Catastrophizing Scale

Timepoint [6]

Commenced at Baseline and conducted at each visit (days 4,8,11,15,18,22,25,29 and 32)

Eligibility

Key inclusion criteria

Patients will have been implanted with a BurstDr electrical stimulator, and will report significant pain relief (defined as average pain less than 3/10 from their stimulator ) and minimal requirements for analgesic medication ( defined as less than 20 Morphine Equivalent Dose (MEq) ) and without any accompanying sensation from electrical stimulation.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients without BurstDr Stimulators
Patients with BurstDR Stimulators that do not report significant pain relief
Patients with BurstDR Stimulators that report significant pain relief but experience parasthesia
Patients that have pain "washout"and " wash in"intervals ( ie when the device is switched off and then on again ) of longer than 2 days

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)

Allocation concealed by central allocation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated Random Number Sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

not applicable

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

8-10 participants to be recruited represents the population of patients at Dr Salmons pain practice who have been implanted with a BurstDR electrical spinal cord stimulator who are potentially eligible . In our previous study, significant benefits of high-frequency electrical stimulation were identified in a sample of 10 patients during a short period of stimulation (4 hours)( Finch et al., 2019). Therefore, we expect to see similar or greater benefits over 3-4 day intervals of stimulation in a similar sized group.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

3/08/2020

Actual

10/09/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

20/10/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

6011 - Cottesloe

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abbott Medical Australia Pty Ltd

Address [1]

1C 21 Teddington Road Burswood Perth WA 6100 Australia

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Abbott Medical Australia

Address

1C 21 Teddington Road Burswood Perth WA 6100 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Murdoch University

Address [1]

SHEE College
90 South Street
Murdoch
WA 6150

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Ethics Committee

Ethics committee address [1]

Murdoch University
Human Ethics Office
Room1.006 Chancery Building
90 South Street
 Murdoch
 WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/03/2020

Approval date [1]

01/05/2020

Ethics approval number [1]

Summary

Brief summary

Clinical audit data suggests that electrical stimulation of the spinal cord is an effective treatment for chronic pain. but only a few high-quality experimentally-controlled studies of this treatment have been reported. We now wish to investigate effects of this stimulation on pain and associated symptoms (sleep and mood) in a double-blind randomised controlled trial. Specifically, we will compare pain and sensitivity to painful stimuli pressure and sharpness) while the stimulator is switched on and 3-4 days after the stimulator has been switched off. As BurstDR parasthesia free stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e , neither the participant nor investigator will know whether the stimulator is switched on or off). The therapeutic benefits of electrical stimulation will be evaluated in the patients own environment while they carry out their normal activities. The patient will monitor their pain, mood, analgesic consumption and sleep over 8 3-4 day blocks. The stimulator will be switched off during two of these blocks.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr John Salmon

Address

Dr Salmons Rooms
Specialist in Pain Management
Parkland House
2/89 Forrest Street
Cottesloe
WA
6011

Country

Australia

Phone

+61 8 9284 6005

Fax

+61 8 92845759

[email protected]

Contact person for public queries

Name

John Salmon

Address

Dr John Salmon Rooms
Specialist in Main Management
Parkland House
2/89 Forrest Street
Cottesloe
WA
6011

Country

Australia

Phone

+61 8 92846005

Fax

+61 8 92845759

[email protected]

Contact person for scientific queries

Name

Peter Drummond

Address

SHEE College
Perth Campus
Murdoch University
90 South Street
Murdoch
WA 6150

Country

Australia

Phone

+61 8 9284 6005

Fax

+61 8 9284 5759

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All participant trial data once de-identified i.e Brief Pain Inventory scores, Sleep Diary, Depression, Anxiety and Stress Scale and Pain Catastrophizing Scale, levels of analgesic medication consumed and pressure pain scores.

When will data be available (start and end dates)?

Data will be available immediately following publication and will be available for five years after publication.

Available to whom?

Anyone who wishes to access it.

Available for what types of analyses?

Comparisons of mean pain ratings during double-blind periods of stimulation "on" versus "off "using paired t-test. Also repeated measures AVOVA for mean pain ratings during days 1-4 ( unblinded baseline) will be compared with the double-blind period of stimulator "on" (3-4 days) and stimulator "off " (3-4 days). De identified patient information will be avaliable for meta-analysis.

How or where can data be obtained?

Access subject to approvals by Principle Investigators : Dr Salmon email [email protected] and Dr Peter Drummond email [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7976	Informed consent form					379835-(Uploaded-18-05-2020-13-46-45)-Study-related document.pdf
7977	Ethical approval					379835-(Uploaded-29-06-2020-11-55-26)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Spinal cord stimulation for low back pain.	2023	https://dx.doi.org/10.1002/14651858.CD014789.pub2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically