Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000584639
Ethics application status
Not yet submitted
Date submitted
23/05/2014
Date registered
30/05/2014
Date last updated
30/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
21-SMI-2014 A Post Market Observational Study on the Effect of Dorsal Root Ganglion (DRG) Stimulation in Patients with Chronic Low Back Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome)
Scientific title
A Post Market Observational Study on the Effect of DRG Stimulation in Patients with Chronic Low Back Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome): SYMPATHY Study
Secondary ID [1] 284657 0
21-SMI-2014
Universal Trial Number (UTN)
U1111-1157-2704
Trial acronym
SYMPATHY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain following surgical lumbar discectomy (Failed Back Surgery Syndrome) 291983 0
Condition category
Condition code
Anaesthesiology 292325 292325 0 0
Pain management
Musculoskeletal 292360 292360 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study on the effectiveness of DRG Stimulation. DRG stimulation is a type of Spinal Cord Stimulation (SCS) which targets specific neural structures with electrical therapy by implanting a stimulating electrode in the epidural space. Suitable subjects will first have a trial of the therapy to determine effect and if successful will have the full system implanted. Implanted subjects will be followed prospectively for 1 year with follow up observations at 1 week, 1 month, 3 month, 6 month and 12 months post implant.
Intervention code [1] 289440 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292190 0
Pain Relief using a 100mm Visual Analogue Scale (VAS)
Timepoint [1] 292190 0
12 Months
Secondary outcome [1] 308398 0
Safety - Continual monitoring for device related (Serious) Adverse Events (S)AE's
Possible Adverse Events related to the therapy will be have been fully explained to potential subjects by the primary investigator as part of their pre-treatment screening and evaluation
Timepoint [1] 308398 0
12 Months
Secondary outcome [2] 308429 0
Quality of Life - EQ-5D
Timepoint [2] 308429 0
12 Months
Secondary outcome [3] 308430 0
Subject Satisfaction - 7 Point Likert Scale
Timepoint [3] 308430 0
12 Months
Secondary outcome [4] 308431 0
Physical Function - Brief Pain Inventory (BPI) and Oswestry Disability Index (ODI)
Timepoint [4] 308431 0
12 Months

Eligibility
Key inclusion criteria
Chronic Low Back Pain following surgical lumbar discectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgical spinal procedures other than a lumbar discectomy
Significant bi-lateral leg pain greater in intensity than their low back pain

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289287 0
Commercial sector/Industry
Name [1] 289287 0
Spinal Modulation Pty Ltd
Country [1] 289287 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Spinal Modulation Inc
Address
1135 O'Brien Drive
Menlo Park - 94025
CA
USA
Country
United States of America
Secondary sponsor category [1] 287958 0
None
Name [1] 287958 0
Address [1] 287958 0
Country [1] 287958 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291053 0
Bellberry Ltd
Ethics committee address [1] 291053 0
Ethics committee country [1] 291053 0
Australia
Date submitted for ethics approval [1] 291053 0
22/05/2014
Approval date [1] 291053 0
Ethics approval number [1] 291053 0
2014-05-270

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

Contacts
Principal investigator
Name 48666 0
Dr Marc Russo
Address 48666 0
Australian Pain Research Centre T/A Hunter Clinical Research
220 Denison Street
Broadmeadow
NSW - 2292
Country 48666 0
Australia
Phone 48666 0
+61 2 4985 1848
Fax 48666 0
Email 48666 0
[email protected]
Contact person for public queries
Name 48667 0
Tiana Laurie
Address 48667 0
Australian Pain Research Centre T/A Hunter Clinical Research
220 Denison Street
Broadmeadow
NSW - 2292
Country 48667 0
Australia
Phone 48667 0
+61 2 4985 1848
Fax 48667 0
Email 48667 0
[email protected]
Contact person for scientific queries
Name 48668 0
Marc Russo
Address 48668 0
Australian Pain Research Centre T/A Hunter Clinical Research
220 Denison Street
Broadmeadow
NSW - 2292
Country 48668 0
Australia
Phone 48668 0
+61 2 4985 1848
Fax 48668 0
Email 48668 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.