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Trial registered on ANZCTR


Registration number
ACTRN12618000721202
Ethics application status
Approved
Date submitted
20/01/2018
Date registered
2/05/2018
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
To evaluate the effectiveness of two (2) different waveforms of Spinal Cord Stimulation in a population of patients with back and leg pain due to failed back surgery syndrome
Scientific title
To evaluate the effectiveness of two (2) different waveforms of Spinal Cord Stimulation in a population of patients with back and leg pain due to failed back surgery syndrome
Secondary ID [1] 293827 0
Nil known
Universal Trial Number (UTN)
U1111-1208-1676
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed Back Surgery Syndrome 306256 0
Condition category
Condition code
Anaesthesiology 305358 305358 0 0
Pain management
Neurological 305858 305858 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All eligible subjects will undergo an SCS Device Trial that includes an intraoperative and programming trial chosen at random between a Burst ( 40 Hz, 1000 µsec) stimulation and High Density (HD) stimulation (1000 Hz and 90 µsec) waveform at subthreshold levels. Total of 20 subjects will be enrolled.
The initial system will be chosen at random between BURST and HD. Total trial will be 10 days divided in the following way: Procedure trial will be done and leads placed. This is day 0. In days 1 and 2 (the initial 48 hours post-trial) no stimulation will be done to help patient recover from post-procedural pain. Then day 3, then the first company which was chosen at random will have a 3-days of trial (days 3, 4 and 5) followed by a two-day washout (days 6 and 7) period, and then a 3-day trial (days 8, 9 and 10) with the second system.
Subjects experiencing a positive response to either HD stimulation or BURST during this trial, defined as a subject-reported assessment with equal or greater 50% improvement in overall pain (trunk and limb) from baseline, will move forward with a permanent implant. The patient will decide which systems they prefer and why. Those not reporting a positive response (less than 50% pain relief) during the trial will be exited from the study.
If the patient is initially enrolled in the Programming trial. HD stimulation will be programmed for pain relief and comfort at 1000 Hz and 90 µsec.
After a successful programming trial, with either of the two systems, patient will be scheduled for implant of a permanent system. The subjects will receive an permanent implant with either the Medtronic Intellis Platform SureScan MRI Rechargeable neurostimulator or the the Prodigy MRI™ Implantable Pulse Generator. Two weeks after permanent placement, if pain relief is inadequate (VAPS less than 50%) during a continuous period of more than 2 weeks, without migration, the patient may change from HD or BURST to Low Density (LD). The purpose is to achieve equal to or greater than 50% pain relief.
Approximately 9-12 days post-implant after the wound has healed, the device will be activated and programmed to the parameters that were successful at trialing.
Intervention code [1] 300088 0
Treatment: Devices
Comparator / control treatment
BURST stimulation will be programmed for pain relief and comfort at ( 40 Hz, 1000 µsec).
Control group
Active

Outcomes
Primary outcome [1] 304505 0
Effectiveness with equal to or greater than 50% pain relief.

To demonstrate an improvement in average overall pain [as measured by the diary-reported Numeric Pain Rating Scale (NPRS)] from baseline to the end of trial in subjects programmed with two different waveforms. In the event of equal decrease in the overall pain, the subject will decide which system they prefer and why.
Timepoint [1] 304505 0
Evaluation of First Programming Trial (Day 5)
Evaluation of Second Programming Trial (Day 10).

At end of trial the effectiveness (equal or greater than 50& pain relief) will be determined with both systems. The one with the higher effectiveness will be recommended to be implanted.
Secondary outcome [1] 342177 0
Evaluate study subject impression of change, as measured by the Patient Global Impression of Change (PGIC).
Timepoint [1] 342177 0
3-Month Visit, 6-Month, and 12-Month Visits.
Secondary outcome [2] 342178 0
1. Characterize changes in average back pain intensity, measured by the diary-reported NPRS, from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [2] 342178 0
3-month, 6-Month, and 12-Month Visits
Secondary outcome [3] 343565 0
2. Characterize changes in average leg pain intensity, measured by the diary-reported NPRS, from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [3] 343565 0
3-Month, 6-Month, and 12-Month Visits
Secondary outcome [4] 343566 0
3. Characterize changes in quality of life-related outcomes (as measured by the EuroQol-5D [EQ-5D-5L]) from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [4] 343566 0
3-Month, 6-Month, and 12-Month Visits.
Secondary outcome [5] 343567 0
4. Characterize changes in functional disability (as measured by the Oswestry Disability Index [ODI]) from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [5] 343567 0
3-Month, 6-Month, and 12-Month Visits.
Secondary outcome [6] 343568 0
5. Summarize subject satisfaction (as measured by the Subject Satisfaction Assessment [SSA]) from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [6] 343568 0
3-Month, 6-Month, and 12-Month Visits.
Secondary outcome [7] 343569 0
6. Characterize sleep assessment (as measured by the Pain and Sleep Questionnaire three-item index (PSQ-3) from baseline to the 3-Month, 6-Month, and 12-Month Visits.
Timepoint [7] 343569 0
3-Month, 6-Month, and 12-Month Visits.
Secondary outcome [8] 343570 0
11. Characterize the percentage of subjects who achieve their activity goal(s), as measured by the Activity Goal Assessment (AGA), from Baseline through the 3-Month, 6-Month, and 12-Month Visits
Timepoint [8] 343570 0
3-Month, 6-Month, and 12-Month Visits
Secondary outcome [9] 343572 0
8. Characterize device programming parameters and paresthesia coverage.
What frequency, pulse width and amplitude are used for each patient based on high density vs burst parameters.
Is the patient obtaining paresthesia coverage over the areas of pain. Paresthesias are assessed by patient description of tingling sensation.
These are composite secondary outcomes.
Timepoint [9] 343572 0
at 3-Month Visit, 6-Month, and 12-Month Visits.
Secondary outcome [10] 343573 0
9. Characterize the implant to trial ratio. How many patients who undergo trial go to a permanent placement. determined from study results and records
Timepoint [10] 343573 0
At end of trial day 10.
Secondary outcome [11] 343574 0
10. Characterize stimulation sensation over the duration of the study (as measured by the Stimulation Sensation Questionnaire [SSQ]).
Timepoint [11] 343574 0
at 3-, 6- and 12-months

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Candidate for SCS system (trial and implant) per labeled indication (back and leg pain)
2. Baseline diary-reported average NPRS is equal or greater than 5 for both trunk and limbs pain.
3. Willing and able to provide a signed and dated informed consent
4. At least 18 years old at the time of informed consent
5. Willing and able to attend visits and comply with the study protocol
6. Capable of using the patient programmer and recharging the neurostimulator
7. Willing to not increase pain medications from baseline through the end of trial Visit
8. Baseline diary completed for a minimum of 3 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:
1. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results.
2. Based on the medical opinion of the Principal Investigator, Sub- Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), or other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of significant pain medications) that would preclude his/her enrollment in the study or potentially confound the results of the study
3. Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system which utilizes tonic (paresthesia) stimulation.
4. Unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
The sample size to evaluate the primary objective at the end of trial visit is 20 subjects who were successfully programmed.
Only subjects who are implanted and have their devices activated will be
included in the evaluation of the primary and secondary endpoints.
The primary objective analysis will test the average change in overall pain
from Baseline to the 3-Month Visit against no change, using a two-sided, one
sample t-test with alpha = 0.05.
The secondary objectives are not alpha-controlled; they will be characterized
but not evaluated with statistical testing.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/03/2018
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
20
Accrual to date
18
Final
Recruitment outside Australia
Country [1] 9503 0
United States of America
State/province [1] 9503 0
GEORGIA

Funding & Sponsors
Funding source category [1] 298441 0
Self funded/Unfunded
Name [1] 298441 0
Vincent Galan, MD
Country [1] 298441 0
United States of America
Primary sponsor type
Individual
Name
Vincent Galan, MD
Address
Pain Care
Attn: Vincent Galan, MD
1365 Rock Quarry Road, Suite 202
Stockbridge, Georgia 30281
Country
United States of America
Secondary sponsor category [1] 298359 0
None
Name [1] 298359 0
Address [1] 298359 0
Country [1] 298359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299437 0
Western IRB
Ethics committee address [1] 299437 0
Ethics committee country [1] 299437 0
United States of America
Date submitted for ethics approval [1] 299437 0
19/01/2018
Approval date [1] 299437 0
08/02/2018
Ethics approval number [1] 299437 0
20180264

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

Contacts
Principal investigator
Name 80398 0
Dr Vincent Galan
Address 80398 0
Pain Care
Attn: Dr Vincent Galan
1365 Rock Quarry Rd Suite 202,
Stockbridge, GA 30281
Country 80398 0
United States of America
Phone 80398 0
+1-770-771-6580
Fax 80398 0
+1-770-771-6589
Email 80398 0
vgalan@msn.com
Contact person for public queries
Name 80399 0
Kamree Parker
Address 80399 0
Pain Care
Attn: Kamree Parker
1365 Rock Quarry Rd Suite 202,
Stockbridge, GA 30281
Country 80399 0
United States of America
Phone 80399 0
+1-770-771-6580
Fax 80399 0
+1-770-771-6589
Email 80399 0
vgalan@msn.com
Contact person for scientific queries
Name 80400 0
Vincent Galan
Address 80400 0
Pain Care
Attn: Vincent Galan, MD
1365 Rock Quarry Rd Suite 202,
Stockbridge, GA 30281
Country 80400 0
United States of America
Phone 80400 0
+1-770-771-6580
Fax 80400 0
+1-770-771-6589
Email 80400 0
vgalan@msn.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator


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.