Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001118998
Ethics application status
Not yet submitted
Date submitted
6/10/2011
Date registered
26/10/2011
Date last updated
26/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Frequency and Pulse Duration Programming in Spinal Cord Stimulation
Scientific title
An Observational Study of the Effect of Frequency and Pulse Duration Programming on Paresthesia Perception in Spinal Cord Stimulation for Low Back Pain
Secondary ID [1] 273175 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 278927 0
Condition category
Condition code
Musculoskeletal 279107 279107 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Obervation of the effect of the varying pulse duration and frequency on paresthesia perception. Participants are observed for several hours on one day only. The whole study is expected to be completed in 9 months.
Intervention code [1] 269506 0
Not applicable
Comparator / control treatment
Spinal Cord Stimulation uses pain-masking signals which travel along one or two leads attached from an Implantable Pulse Generator. This patient perceives paresthesia in the area of pain following the programming of the device by the doctor or technician. The programs are based on the electrode polarity, pulse width, pulse frequency & amplitude based on patient feedback of area & type of paresthesia. The programming is done by adjusting the electrode polarity, choosing pulse width & frequency according to the doctor / technician’s experience, increasing the amplitude to perception & asking the patient for feedback before trying further parameters. Programming is not usually done following a set matrix of frequency & pulse width. Observational period extends to include the period for which the patient has the implant insitu.
Control group
Active

Outcomes
Primary outcome [1] 279747 0
Changes in paresthesia perception related to location and extent of paresthesia begins by patient choosing the favourite/best coverage area from the programmed settings and draws area of pain on Tablet PC Template. All testing is conducted on the chosen electrode configuration. Patient records baseline Pain scores (VAS) historic, recalled pre-implant as well present score with stimulation off and stimulation on. Experienced Spinal cord stimulation programmer determines thresholds for perception, minimum and maximum comfortable which patient records on tablet PC template. Patient also reports paresthesia descriptors and rates percentage pain areas covered on data collection form.
Timepoint [1] 279747 0
Immediately after each observation
Primary outcome [2] 279768 0
Changes in VAS, description of paresthesia sensation and effect of order of presentation of different frequencies and pulse durations will be recorded (as above) utilising the Tablet PC Template and paper based patient reported outcome data sheets.
Timepoint [2] 279768 0
Immediately after each observation
Secondary outcome [1] 294360 0
Changes in reported pain relief (VAS)
Timepoint [1] 294360 0
Immediately after each observation
Secondary outcome [2] 294397 0
Changes in description of paresthesia sensation
Timepoint [2] 294397 0
Immediately after each observation
Secondary outcome [3] 294398 0
Effect of order of presentation of different frequencies and pulse durations
Timepoint [3] 294398 0
Immediately after each observation

Eligibility
Key inclusion criteria
Patients implanted with Precision Spinal Cord Stimulator (SCS) system for > 3 months
Epidural lead(s) implanted between T6 and T12 for chronic neuropathic pain of the trunk or limbs
Ability to use tablet pen to draw paresthesia coverage on computer graphics program
Capable of giving written consent and willingness 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
Other major pain area not targeted by Spinal Cord Stimulator (SCS) system
Potential for further surgery: Spinal Cord Stimulator (SCS) revision, other surgery for pain
Other medical condition likely to interfere with study procedures or likely to confound evaluation of endpoints
Currently unable to use the device due to device problems or other medical conditions
Pregnancy

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269999 0
Commercial sector/Industry
Name [1] 269999 0
Boston Scientific
Country [1] 269999 0
United States of America
Primary sponsor type
Individual
Name
Dr Marc Russo
Address
Hunter Clinical Research
91 Chatham Street
Broadmeadow
Newcastle NSW 2292
Country
Australia
Secondary sponsor category [1] 268980 0
Individual
Name [1] 268980 0
Dr Peter Georgius
Address [1] 268980 0
Selangor Medical Centre
62 Netherton St, Nambour
QLD 4560
Country [1] 268980 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271959 0
Bellberry
Ethics committee address [1] 271959 0
Ethics committee country [1] 271959 0
Australia
Date submitted for ethics approval [1] 271959 0
07/10/2011
Approval date [1] 271959 0
Ethics approval number [1] 271959 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33246 0
Address 33246 0
Country 33246 0
Phone 33246 0
Fax 33246 0
Email 33246 0
Contact person for public queries
Name 16493 0
Dr Marc Russo
Address 16493 0
91 Chatham Street
Broadmeadow
NSW 2292
Country 16493 0
Australia
Phone 16493 0
+61 (2) 49 851 860
Fax 16493 0
+61 (2) 49 400 322
Email 16493 0
[email protected]
Contact person for scientific queries
Name 7421 0
Dr Marc Russo
Address 7421 0
91 Chatham Street
Broadmeadow
NSW 2292
Country 7421 0
Australia
Phone 7421 0
+61 (2) 49 851 860
Fax 7421 0
+61 (2) 49 400 322
Email 7421 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.