Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001274662
Ethics application status
Approved
Date submitted
9/06/2013
Date registered
5/12/2014
Date last updated
5/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the therapeutic effect of electrical impulses with short pulse width on pain relief and quality of the spinal cord stimulation in patients with intractable back and/or leg pain.
Scientific title
An investigation of the therapeutic effect of electrical impulses with short pulse width on pain relief and quality of the spinal cord stimulation in patients with intractable back and/or leg pain.
Secondary ID [1] 282644 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Electrical impulses for pain relief in patients with intractable back and/or leg pain 289346 0
Condition category
Condition code
Musculoskeletal 289682 289682 0 0
Other muscular and skeletal disorders
Anaesthesiology 289683 289683 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study of the effects of alternative programming options/combinations, as part of routine standard of care, on chronic intractable back and/or leg pain in patients currently implanted with the Boston Scientific Corporation spinal cord stimulator (BSC SCS).

Patients will be followed up 7-10 days following re-programming, and then periodically, as per standard of care, throughout the entire study period (until the study is closed - approximately 24 months). No outcome assessments are conducted post 7-10 days.
Intervention code [1] 287312 0
Not applicable
Comparator / control treatment
N/A - this is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289770 0
Improvement in pain relief as determined by the patient via questionnaires: visual analogue scales (VAS), pain severity score, pain and parasthesia mapping .
Timepoint [1] 289770 0
A baseline assessment of all quesionnaires will be made preceding the alternative programming, followed by twice daily assessments during the temporary trial period which will last 7-10 days
Secondary outcome [1] 303211 0
nil
Timepoint [1] 303211 0
nil

Eligibility
Key inclusion criteria
1. 18 years old or over
2. Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
3. Have current SCS implant (Boston Scientific)
4. Willing and able to complete protocol requirements including:
a. Willing and able to complete health questionnaires and pain scales as specified in the protocol
b. Willing and able to sign the study-specific Informed Consent form
c. Willing and able to operate SCS implant remote control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have plans to enrol in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Both qualitative and quantitative data will be collected and analysed using PASW Statistics 18.0. Non-parametric 2-tailed cross sectional and pair-wise comparisons will be undertaken between conventional “buzzing” stimulation and paraesthesia free stimulation. Significance will be set at the 0.05 level.

This is an exploratory study, therefore there is no predefined sample size justification. Large sample sizes in exploratory studies are desired to allow for subgroup analysis and hypothesis generation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
15/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 287424 0
Commercial sector/Industry
Name [1] 287424 0
Boston Scientific Neuromodulation Corporation
Country [1] 287424 0
United States of America
Primary sponsor type
Individual
Name
Dr. Paul Verrills
Address
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country
Australia
Secondary sponsor category [1] 286172 0
Individual
Name [1] 286172 0
Dr. Marc Russo
Address [1] 286172 0
Hunter Pain Clinic
91 Chatham St
Broadmeadow NSW 2292
Country [1] 286172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291232 0
Bellberry Ltd.
Ethics committee address [1] 291232 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 291232 0
Australia
Date submitted for ethics approval [1] 291232 0
24/04/2013
Approval date [1] 291232 0
15/07/2013
Ethics approval number [1] 291232 0
2013-04-158

Summary
Brief summary
Prospective, observational study. Subjects who have inadequate pain relief from their currently implanted conventional spinal cord stimulator (Boston Scientific Corp.) will be evaluated for eligibility in this study.

The study aims at investigating alternative programming combinations for these spinal cord devices. The programming algorithms are within the currently approved limits for the device. We hope to reduce the stimulation (paraesthesia) to a level in which it is no longer felt by the patient (subthreshold stimulation) but still provides improved pain relief and prolonged optimal therapy for patients with chronic back and leg pain.

The potential outcomes of this project have vast applications in chronic pain patients, where patients will often tolerate side effects such as uncomfortable stimulation sensations, so that their pain may be controlled.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40638 0
Dr Paul Verrills
Address 40638 0
Metro Spinal Clinic
Level 1, 544 Hawthorn Road
Caulfield South, VIC 3162
Country 40638 0
Australia
Phone 40638 0
+61 3 9595 6111
Fax 40638 0
Email 40638 0
[email protected]
Contact person for public queries
Name 40639 0
Ms Alison Meeking
Address 40639 0
Metro Spinal Clinic
Level 1, 544 Hawthorn Road
Caulfield South, VIC 3162
Country 40639 0
Australia
Phone 40639 0
+61 3 9595 6111
Fax 40639 0
Email 40639 0
[email protected]
Contact person for scientific queries
Name 40640 0
Dr Adele Barnard
Address 40640 0
Metro Spinal Clinic
Level 1, 544 Hawthorn Road
Caulfield South, VIC 3162
Country 40640 0
Australia
Phone 40640 0
+61 3 9595 6111
Fax 40640 0
Email 40640 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.