Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000022066
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
8/01/2010
Date last updated
8/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Spinal Cord Stimulation (SCS) Partnership for Advancements In Neuromodulation (PAIN) Outcome Registry
Scientific title
Partnership for Advancements In Neuromodulation (PAIN) observational patient registry: a prospective, non-interventional, multicentre data collection of real-world patient experience in those who have received Food and Drug Administration (FDA) approved St Jude Medical (SJM) implantable device"
Secondary ID [1] 1253 0
None
Universal Trial Number (UTN)
Trial acronym
PAIN Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The St. Jude Medical Spinal Cord Stimualtion (SCS) system is designed to treat certain types of chronic, intractable pain syndromes of the trunk and limbs. 256479 0
Condition category
Condition code
Anaesthesiology 256639 256639 0 0
Pain management
Neurological 256662 256662 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Spinal Cord Stimulation System Components.
The spinal cord stimulation system and related components to be used in this 2 year registry (this registry is the means in which data will be collected for this observational study and analysis) are currently available and FDA approved for use for spinal cord stimulation i.e. The devices are currently cleared for market and distribution in the United States for chronic intractable pain of the trunk and/or limbs.
The registry is a database on patient outcomes as a result of SCS interventions and devices
Intervention code [1] 255763 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257544 0
Pain Disability Index
Timepoint [1] 257544 0
Baseline
3 months
6 months
12 months
18 months
24 months
Secondary outcome [1] 262781 0
Quality of Life by patient reported questionnaire (functional changes, work status, satisfaction)
Timepoint [1] 262781 0
Baseline
3 months
6 months
12 months
18 months
24 months

Eligibility
Key inclusion criteria
Inclusion Criteria:
Patients enrolled in this registry will comply with the following inclusion criteria:
1.Patient has signed and received a copy of the Informed Consent form;
2.Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;
3.Patient is 18 years of age or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non compliance with inclusion criteria (protocol only details inclusions criteria as registry open to ALL patients over 18yo with a SJM Neuro device)

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2384 0
United States of America
State/province [1] 2384 0

Funding & Sponsors
Funding source category [1] 256251 0
Commercial sector/Industry
Name [1] 256251 0
St Jude Medical Australia
Country [1] 256251 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical Neuromodulation Division
Address
6901 Preston Road
Plano, Texas 75024
Country
United States of America
Secondary sponsor category [1] 251580 0
None
Name [1] 251580 0
Address [1] 251580 0
Country [1] 251580 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To obtain “real-world” clinical outcomes of neuromodulation in patients with St. Jude Medical Neuromodulation Division devices.
An observational registry is defined as non-interventional research that involves the collection of scientifically valuable information for the purpose of answering important research questions. The term 'non-interventional' means that the healthcare provider's decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice.
Trial website
Nil
Trial related presentations / publications
TBA
Public notes

Contacts
Principal investigator
Name 30660 0
Address 30660 0
Country 30660 0
Phone 30660 0
Fax 30660 0
Email 30660 0
Contact person for public queries
Name 13907 0
Erin Triglone
Address 13907 0
17 Orion Road
Lane Cove NSW 2066
Country 13907 0
Australia
Phone 13907 0
+61 2 9936 1237
Fax 13907 0
+61 2 9936 1222
Email 13907 0
[email protected]
Contact person for scientific queries
Name 4835 0
Erin Triglone
Address 4835 0
17 Orion Road
Lane Cove NSW 2066
Country 4835 0
Australia
Phone 4835 0
+61 2 9936 1237
Fax 4835 0
+61 2 9936 1222
Email 4835 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.