Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000739213
Ethics application status
Approved
Date submitted
20/08/2009
Date registered
26/08/2009
Date last updated
26/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Spinal Modulation Neurostimulator System in the Treatment of Chronic Pain
Scientific title
Does the Spinal Modulation Neurostimulator System provide safe and efficacious pain relief in people with chronic pain?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 243555 0
Condition category
Condition code
Anaesthesiology 239857 239857 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study uses an invasive neurostimulation device that is used for up to 24 hours per day. Duration of treatment in this study is 3-10 days. Part of the device is implanted in the patient and the device is controlled with a hand held remote. The amount of therapy used throughout the day is patient controlled.
Intervention code [1] 241159 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240635 0
Safety as assessed by complications and adverse events. Adverse events can include increasing pain, numbness and events associated with epidural needle access. These will be assessed daily via interview and questionnaires.
Timepoint [1] 240635 0
Daily assessments for 3-10 days following treatment
Secondary outcome [1] 257270 0
Pain Relief as assessed by visual analog scale
Timepoint [1] 257270 0
Daily assessments for 3-10 days following treatment

Eligibility
Key inclusion criteria
1. Chronic pain
2. Failed conservative treatments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primarily axial back pain

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237526 0
Commercial sector/Industry
Name [1] 237526 0
Spinal Modulation
Country [1] 237526 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Five Corners Pty Ltd
Address
Five Corners Pty Ltd
13/76 Reserve Road
ARTARMON NSW 2064
Country
Australia
Secondary sponsor category [1] 237001 0
None
Name [1] 237001 0
Address [1] 237001 0
Country [1] 237001 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the current study is to determine the safety and efficacy of a neuromodulation therapy in the treatment of chronic pain. We hypothesize that this study will demonstrate safe delivery of therapy which will result in significant pain relief.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30037 0
Address 30037 0
Country 30037 0
Phone 30037 0
Fax 30037 0
Email 30037 0
Contact person for public queries
Name 13284 0
Jeff Kramer, PhD
Address 13284 0
Spinal Modulation
1135 O'Brien Dr.
Menlo Park, CA 94025
Country 13284 0
United States of America
Phone 13284 0
+1 650-543-6836
Fax 13284 0
Email 13284 0
[email protected]
Contact person for scientific queries
Name 4212 0
Jeff Kramer, PhD
Address 4212 0
Spinal Modulation
1135 O'Brien Dr.
Menlo Park, CA 94025
Country 4212 0
United States of America
Phone 4212 0
+1 650-543-6836
Fax 4212 0
Email 4212 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.