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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
2/07/2020
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] 301293 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic back pain 317467 0
The effects of pain on sleep quality 317508 0
Condition category
Condition code
Musculoskeletal 315568 315568 0 0
Other muscular and skeletal disorders
Mental Health 315606 315606 0 0
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] 317592 0
Treatment: Devices
Intervention code [2] 317593 0
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] 323811 0
Assessment of pain using Brief Pain Inventory
Timepoint [1] 323811 0
Commencing Baseline (day 1) of study and completed daily until end of study (day 32)
Primary outcome [2] 323812 0
Assessment of quality of sleep using Sleep Diary
Timepoint [2] 323812 0
Daily from Baseline (day 1) and completed daily until the end of the study ( day 32)
Primary outcome [3] 323813 0
Consumption of analgesic medication using daily medication diary
Timepoint [3] 323813 0
Recorded daily from Baseline ( day 1) until end of study (day 32).
Secondary outcome [1] 382968 0
Patient mood using the Depression, Anxiety and Stress Scale-21 (DASS-21)
Timepoint [1] 382968 0
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] 382971 0
Patient activity using a pedometer
Timepoint [2] 382971 0
Worn daily from Baseline ( day 1) until end of study (day 32)
Secondary outcome [3] 382973 0
Assessment of behavioural signs of pain using Pain Behavioural Score
Timepoint [3] 382973 0
Commenced at Baseline and conducted at every visit ( days 4,8,11,15,18,22,25,29 and 32)
Secondary outcome [4] 382980 0
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] 382980 0
Commenced at Baseline and conducted at each visit (days 4,8,11,15,18,22,25,29,and 32)
Secondary outcome [5] 383735 0
Patient anxiety levels using DASS-21 and Pain Catastrophizing Scale
Timepoint [5] 383735 0
Commenced at Baseline and conducted at each visit (days 4, 8,11,15,18, 22,25,29 and 32)
Secondary outcome [6] 383736 0
Patient stress levels using DASS-21 and Pain Catastrophizing Scale
Timepoint [6] 383736 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Not yet recruiting
Date of first participant enrolment
Anticipated
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)
WA
Recruitment postcode(s) [1] 30283 0
6011 - Cottesloe

Funding & Sponsors
Funding source category [1] 305732 0
Commercial sector/Industry
Name [1] 305732 0
Abbott Medical Australia Pty Ltd
Address [1] 305732 0
1C 21 Teddington Road Burswood Perth WA 6100 Australia
Country [1] 305732 0
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] 306155 0
None
Name [1] 306155 0
Address [1] 306155 0
Country [1] 306155 0
Other collaborator category [1] 281315 0
University
Name [1] 281315 0
Murdoch University
Address [1] 281315 0
SHEE College
90 South Street
Murdoch
WA 6150
Country [1] 281315 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306007 0
Murdoch University Ethics Committee
Ethics committee address [1] 306007 0
Murdoch University
Human Ethics Office
Room1.006 Chancery Building
90 South Street
Murdoch
WA 6150
Ethics committee country [1] 306007 0
Australia
Date submitted for ethics approval [1] 306007 0
16/03/2020
Approval date [1] 306007 0
01/05/2020
Ethics approval number [1] 306007 0

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 102398 0
Dr John Salmon
Address 102398 0
Dr Salmons Rooms
Specialist in Pain Management
Parkland House
2/89 Forrest Street
Cottesloe
WA
6011
Country 102398 0
Australia
Phone 102398 0
+61 8 9284 6005
Fax 102398 0
+61 8 92845759
Email 102398 0
johnsalmon@bigpond.com
Contact person for public queries
Name 102399 0
Dr John Salmon
Address 102399 0
Dr John Salmon Rooms
Specialist in Main Management
Parkland House
2/89 Forrest Street
Cottesloe
WA
6011
Country 102399 0
Australia
Phone 102399 0
+61 8 92846005
Fax 102399 0
+61 8 92845759
Email 102399 0
johnsalmon@bigpond.com
Contact person for scientific queries
Name 102400 0
Dr Peter Drummond
Address 102400 0
SHEE College
Perth Campus
Murdoch University
90 South Street
Murdoch
WA 6150
Country 102400 0
Australia
Phone 102400 0
+61 8 9284 6005
Fax 102400 0
+61 8 9284 5759
Email 102400 0
p.drummond@murdoch.edu.au

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 johnsalmon@bigpond.com and Dr Peter Drummond email p.drummond@murdoch.edu.au
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7976 0
Informed consent form
Citation [1] 7976 0
Link [1] 7976 0
Email [1] 7976 0
Other [1] 7976 0
Type [2] 7977 0
Ethical approval
Citation [2] 7977 0
Link [2] 7977 0
Email [2] 7977 0
Other [2] 7977 0
Summary results
No Results