Trial Review

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
ACTRN12614000665639
Ethics application status
Approved
Date submitted
16/06/2014
Date registered
25/06/2014
Date last updated
25/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients
Scientific title
A prospective, single-center, observational data collection study of high-frequency spinal cord stimulation at 10kHz (HF10 SCS) for the Treatment of Post-Surgery Back Pain Patients
Secondary ID [1] 284803 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-frequency spinal cord stimulation in patients with chronic back pain +/- leg pain following spine surgery 292178 0
Condition category
Condition code
Musculoskeletal 292518 292518 0 0
Other muscular and skeletal disorders
Neurological 292519 292519 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 292520 292520 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Twelve month observation of patients implanted with the Senza System for management of chronic back pain +/- leg pain following spinal surgery via spinal cord stimulation.
Intervention code [1] 289593 0
Not applicable
Comparator / control treatment
This is an observational study of all patients meeting criteria and inserted with the Senza System SCS.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292381 0
The primary outcome measure will be degree of pain relief as determined by the patient via numerical rating scales for pain, as well as physician assessments.
Timepoint [1] 292381 0
A baseline assessment will be made prior to undergoing trial SCS implantation, followed by daily assessments during the temporary trial phase (6-14 days). Following permanent implantation, follow up assessments will be scheduled at 3, 6 and 12 months.
Secondary outcome [1] 308827 0
The secondary outcome measure will assess the impact of HF10 SCS on quality of life. This will be assessed via questionnaires addressing levels of depression, anxiety, stress, affected daily activities and daily analgesic use. Questionnaires will include medication use, DASS21, LANSS, ODI, GIC, SF-36 and Subject Satisfaction.
Timepoint [1] 308827 0
A Baseline assessment will be made prior to undergoing trial SCS implantation, followed by an assessment at the end of the temporary trial phase (in 6-14 days). Following permanent implantation, assessments will be scheduled at 3, 6 and 12 months.

Eligibility
Key inclusion criteria
1. undergone spine surgery that resulted in back pain.
2. => 18 years of age
3. Diagnosed with back pain or back pain plus leg pain for at least 6 months
4. Back pain intensity is at least 5 out of 10
5. Undergoing treatment for back pain or back pain plus leg pain
6. Meet the requirements for being an HF10 SCS trial candidate as per the center practice
7. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. plans to enroll 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
This study is statistically not powered for a specific efficacy hypothesis test so no formal sample size has been calculated. Target size has been set on 100 successfully trialed subjects.

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 to assess changes in daily pain scores and daily analgesics use. Simple linear and non-linear regression will be used to calculate possible outcome predictor values from the baseline demographic, pain, daily activity and psychometric data collected. Significance will be set at the 0.05 level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/11/2013
Actual
5/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289417 0
Commercial sector/Industry
Name [1] 289417 0
Nevro Corporation
Country [1] 289417 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] 288100 0
Individual
Name [1] 288100 0
Dr. Bruce Mitchell
Address [1] 288100 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country [1] 288100 0
Australia
Secondary sponsor category [2] 288101 0
Individual
Name [2] 288101 0
Dr. David Vivian
Address [2] 288101 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country [2] 288101 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291176 0
Bellberry Ltd
Ethics committee address [1] 291176 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 291176 0
Australia
Date submitted for ethics approval [1] 291176 0
28/08/2013
Approval date [1] 291176 0
05/11/2013
Ethics approval number [1] 291176 0
2013-08-466

Summary
Brief summary
Patients with persistent back pain and suspected mechanical instability are referred to spine surgeons for spine stability assessment and, if need be, stabilization surgery. A significant proportion of these patients fail however to derive adequate benefits from the surgery and these chronic pain patients are often left with few options.

Traditional spinal cord stimulation (SCS) is a widely accepted, cost-effective therapy for patients with chronic pain, especially in patients with post-surgery back and leg pain.

High-Frequency Spinal Cord Stimulation at 10 kHz (HF10 SCS) has established itself as a key treatment in treating patients with chronic back pain: data from European pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain.

HF10 SCS has been used in Australia to treat chronic pain ever since its TGA approval, especially back and leg pain patients. The purpose of this non-interventional data collection study is to collect data on the improvement in pain relief and quality of life associated with HF10 SCS, as used in the clinic routine practice in patients with chronic back pain following back surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49038 0
Dr Paul Verrills
Address 49038 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 49038 0
Australia
Phone 49038 0
+61 3 9595 6111
Fax 49038 0
Email 49038 0
[email protected]
Contact person for public queries
Name 49039 0
Dr Adele Barnard
Address 49039 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 49039 0
Australia
Phone 49039 0
+61 3 9595 6111
Fax 49039 0
Email 49039 0
[email protected]
Contact person for scientific queries
Name 49040 0
Dr Adele Barnard
Address 49040 0
Metro Spinal Clinic
Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 49040 0
Australia
Phone 49040 0
+61 3 9595 6111
Fax 49040 0
Email 49040 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.