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Trial registered on ANZCTR


Registration number
ACTRN12615000254594
Ethics application status
Approved
Date submitted
22/02/2015
Date registered
19/03/2015
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of spinal cord stimulation on weekly step count of patients with back and leg pain
Scientific title
The effect of spinal cord stimulation on weekly step count of patients with back and leg pain
Secondary ID [1] 286238 0
none
Universal Trial Number (UTN)
U1111-1167-4985
Trial acronym
SCS Activity Monitoring
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back and leg pain 294290 0
Condition category
Condition code
Anaesthesiology 294611 294611 0 0
Pain management
Neurological 294680 294680 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
Spinal cord stimulation (SCS) is used to treat patients with long term nerve pain by applying an electrical current to the spinal cord or peripheral nerves. This is done via small metal contacts called electrodes which are fixed to a cable called a lead. When a pain specialist wants to use a spinal cord stimulator in a patient, the patient has a surgical operation to put one or more leads into the body. These leads are then connected to an external battery which is worn by a patient using a belt. After a “trial” period lasting 1-2 weeks, the effectiveness of the stimulation is assessed and if the ‘trial’ deemed successful a permanent system is implanted.

The stimulators will be programmed by company technicians as per manufacturer guidelines.

Participants will wear a Vivofit (Garmin Ltd) fitness band for 2 weeks before and 1-2 weeks after insertion of the spinal cord stimulator leads.

Patient data from the Vivofit monitor, walking tests and questionnaire responses will be collected during the routine twice weekly outpatient clinic visits used to monitor the clinical progress of the ‘trial’ of stimulation.
Intervention code [1] 291254 0
Not applicable
Comparator / control treatment
Patient acts as own control pre and post spinal cord stimulator lead results will be compared.

The primary endpoint will be comparing Vivofit baseline (pre institution of neurostimulation therapy) total step count for 1 week prior to lead insertion to weekly total step count in the last week of the trial.

Secondary endpoints will compare Vivofit baseline step counts, sleep and activity patterns to self-report questionnaires (BPI, Dass21, ESS, PCS, PSEQ, SF36, OSW), TUG, 6MWT, in addition to medication usage at the same time points.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294375 0
Change in weekly daily step count before and after insertion stimulator leads. Data will uploaded from the Vivofit fitness band by a research assistant at twice weekly routine clinic visits to monitor clinical progress.
Timepoint [1] 294375 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [1] 313301 0
Back and leg pain as assessed using the BPI questionnaire
Timepoint [1] 313301 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [2] 313302 0
Depression, anxiety and stress as assessed using the DASS21 questionnaire
Timepoint [2] 313302 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [3] 313303 0
Sleepiness as assessed using the ESS questionnaire
Timepoint [3] 313303 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [4] 313304 0
Catastrophising as assessed using the PCS questionnaire
Timepoint [4] 313304 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [5] 313305 0
Self-efficacy as assessed using the PSEQ questionnaire
Timepoint [5] 313305 0
baseline week before trial lead insertion v last week of trial leads before implant/removal
Secondary outcome [6] 313306 0
Physical and mental health as assessed using the SF36 questionnaire.
Timepoint [6] 313306 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [7] 313307 0
Back and leg pain as assessed using the OSW questionnaire
Timepoint [7] 313307 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [8] 313308 0
Mobility as assessed using the TUG test
Timepoint [8] 313308 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [9] 313309 0
Functional exercise capacity as assessed using the 6MWT
Timepoint [9] 313309 0
baseline week before lead insertion v last week of leads before implant/removal
Secondary outcome [10] 313310 0
medication usage will be recorded at baseline and trial on the concomitant medication (ConMed) worksheet.
Timepoint [10] 313310 0
baseline week before lead insertion v last week of leads before implant/removal

Eligibility
Key inclusion criteria
- Patients with chronic, intractable back pain, with or without radicular symptoms to one or both legs (with or without prior back surgery) indicated for spinal cord stimulation trial (post spine surgery, neuropathic pain)
- Is a new or existing patient of Frankston Pain Management, Frankston Hospital pain medicine or PainCare clinics
- Has chronic, intractable pain
- Appropriate clinical diagnosis
- Positive psychological evaluation
- No pending lawsuit or economic compensation related to the pain
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who are contraindicated from receiving a spinal cord stimulator,
are likely to be non-compliant or
don’t want to participate.

Specific criteria for exclusion include:
- Patients for dorsal root ganglion stimulation
- Patients having full system implanted without prior period of trial stimulation
- Inability to give informed consent,
- Inability to understand English (most pain assessment tools are validated for English language speakers only),
- Contraindicated for spinal cord stimulation; i.e.: are unable to operate the SCS system, are poor surgical risks, are pregnant
- Non-compliance with stimulator usage and/or stimulation parameter settings
- Unable to wear activity monitor on wrist

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a first time study to compare a new method of outcome evaluation with standard clinical evaluation.

The expected outcome is that 40 patients will allow for a degree of correlation to be established between the 2 measurement methods at each stage of assessment. The degree and nature of any correlation will form the basis for a larger study based on the information gained from this pilot.

Power calculations
We are planning a study with 40 subjects. Prior data indicate that the difference in the response of matched pairs is normally distributed with standard deviation 3000 steps. We will be able to detect a true difference in the mean response of matched pairs of -1363.081 or 1363.081 steps with probability (power) 0.8. The Type I error probability associated with this test of the null hypothesis that this response difference is zero is 0.05.

Statistical methodology
Primary endpoint analysis
The change in step count will be assessed using student paired T-test with each individuals before and after scores.

Secondary endpoints analysis
The data will be analysed using Wilcoxon Rank sum test or Pearson correlation coefficient, subject to data meeting the appropriate criteria as gathered.


Recruitment
Recruitment status
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,VIC
Recruitment hospital [1] 3496 0
Frankston Hospital - Frankston
Recruitment hospital [2] 3497 0
Beleura Private Hospital - Mornington
Recruitment hospital [3] 3529 0
Bethesda Hospital - Claremont
Recruitment postcode(s) [1] 9265 0
3199 - Frankston
Recruitment postcode(s) [2] 9293 0
3931 - Mornington
Recruitment postcode(s) [3] 9294 0
6010 - Claremont
Recruitment postcode(s) [4] 9295 0
6011 - Cottesloe

Funding & Sponsors
Funding source category [1] 290795 0
Commercial sector/Industry
Name [1] 290795 0
Boston Scientific
Address [1] 290795 0
PO Box 332
Botany NSW, 1455
Country [1] 290795 0
Australia
Funding source category [2] 290797 0
Commercial sector/Industry
Name [2] 290797 0
St Jude Medical
Address [2] 290797 0
650 Lorimer St
Port Melbourne Vic 3207
Country [2] 290797 0
Australia
Primary sponsor type
Individual
Name
Dr Murray Taverner
Address
Frankston Pain management
Suite 7, 20 Clarendon Street
Frankston, Victoria 3199
Country
Australia
Secondary sponsor category [1] 289477 0
Individual
Name [1] 289477 0
Dr John Salmon
Address [1] 289477 0
PainCare
2/89 Forest Street
Cottesloe WA 6011
Country [1] 289477 0
Australia
Other collaborator category [1] 278363 0
Individual
Name [1] 278363 0
Dr John Monagle
Address [1] 278363 0
Frankston Pain Management
Suite 7, 20 Clarendon Street
Frankston, Vic, 3199
Country [1] 278363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292423 0
Peninsula Health
Ethics committee address [1] 292423 0
PO Box 52
Frankston, Vic, 3199
Ethics committee country [1] 292423 0
Australia
Date submitted for ethics approval [1] 292423 0
23/02/2015
Approval date [1] 292423 0
07/04/2015
Ethics approval number [1] 292423 0
HREC/15/PH/11

Summary
Brief summary
General activity level in patients being considered for spinal stimulation and the improvement in activity levels after stimulator insertion have not been documented and both are unknown.

In this study physical activity measurements, as measured by the Garmin Vivofit device, will be compared to usual questionnaires that you complete for assessment of pain, pain relief and functional improvement before and after the insertion of spinal cord stimulator leads.

This study involves wearing a wrist band (Vivofit, Garmin Ltd) for 2 weeks before and 1-2 weeks after the insertion of the spinal cord stimulator lead.

The primary endpoint will be comparing Vivofit baseline (pre institution of neurostimulation therapy) total step count for 1 week prior to lead insertion to weekly total step count in the last week of the trial of stimulation.

Secondary endpoints will compare Vivofit baseline step counts to self-report questionnaires (BPI, Dass21, ESS, PCS, PSEQ, SF36, OSW), TUG, 6MWT, in addition to medication usage at the same time points.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55226 0
Dr Murray Taverner
Address 55226 0
Frankston Pain Management
Suite 7, 20 Clarendon Street
Frankston, Vic, 3199
Country 55226 0
Australia
Phone 55226 0
+61397700522
Fax 55226 0
+61397700944
Email 55226 0
mtaverner@phcn.vic.gov.au
Contact person for public queries
Name 55227 0
Mrs Adeline Taverner
Address 55227 0
Frankston Pain Management
Suite 7, 20 Clarendon Street
Frankston, Vic, 3199
Country 55227 0
Australia
Phone 55227 0
+61397700522
Fax 55227 0
+61397700944
Email 55227 0
info@fpmx.com.au
Contact person for scientific queries
Name 55228 0
Dr Murray Taverner
Address 55228 0
Frankston Pain Management
Suite 7, 20 Clarendon Street
Frankston, Vic, 3199
Country 55228 0
Australia
Phone 55228 0
+61397700522
Fax 55228 0
+61397700944
Email 55228 0
mtaverner@phcn.vic.gov.au

No information has been provided regarding IPD availability
Summary results
No Results