Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001139167
Ethics application status
Approved
Date submitted
1/08/2019
Date registered
15/08/2019
Date last updated
19/10/2023
Date data sharing statement initially provided
15/08/2019
Date results provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulation
Scientific title
A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulation
Secondary ID [1] 298902 0
GRS2018-006
Universal Trial Number (UTN)
Trial acronym
PUMP IT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic primary back pain 313880 0
Condition category
Condition code
Anaesthesiology 312292 312292 0 0
Pain management
Neurological 312293 312293 0 0
Other neurological disorders
Musculoskeletal 312376 312376 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve the use of the SynchroMed II drug infusion system (Medtronic), which consists of a programmable pump and catheter, and the use of low dose targeted drug delivery (TDD) therapy in patients with chronic primary back pain who have "failed" spinal cord stimulation (SCS) therapy. "Failed" refers to the loss of efficacy of a permanently implanted SCS system over time, or failure to adequately respond to SCS therapy after implantation, or failure to adequately respond to a trial of SCS therapy. Patients must have failed at least two SCS interventions, or have failed one and are not suitable for subsequent SCS interventions.

The purpose of this study is to assess the efficacy and safety of TDD therapy as an alternative treatment option for these patients.

Eligible patients will receive a permanent implant of a SynchroMed II infusion system, consisting of a programmable pump (20ml or 40ml size) and a catheter. This involves a 60-90 min surgical procedure in which an incision is made in the abdomen for placement of the pump under the skin, and a second incision is made in the back for insertion of the catheter into the intrathecal space, the other end of which is then connected to the pump. The implant visit may or may not include a brief intra-hospital trial of the therapy (infusion or bolus of morphine). The trial method (or no trial) is at the discretion of the Investigator.

Suitable patients who are on systemic opioid medications must undergo a 6-week opioid taper to achieve = 20mg morphine equivalent prior to trial/implantation. The Control Workflow for TDD (Medtronic) will be used as a guide to help eliminate systemic opioids and establish the lowest effective infusion drug dose and the desired refill interval for implanted patients.

The main opioids that will be used intrathecally are morphine sulphate or hydromorphone. The starting intrathecal drug dose will be 0.2mg/day morphine. Following the Control Workflow for TDD, the pump will be programmed to administer drug at a steady state to achieve a 3-month refill interval. For a 20ml pump, this is achieved with a drug dose of 0.2mg/day at a concentration of 1mg/ml and a set flow rate of 0.2ml/day. For a 40ml pump, this is achieved with drug dose 0.2mg/day, concentration 0.5mg/ml, flow rate 0.4ml/day. Drug dose may be increased by 0.1-0.15mg/day every 4-weeks until a clinically effective dose is achieved (50% pain relief or greater) in the absence of significant side effects. The clinically desired target is a total morphine equivalent dose of 1.5mg/day.

Patients will attend routine, standard care follow-up consultations at 1-, 4-, 6- and 12-months post-implant at their participating centres. Information/data to be collected at each visit includes: pump refill information, concomitant medications, pain scores, quality of life scores, health status score, global impression of change, work status.

The study will be conducted across 4 research/pain management centres by a team of 6 highly experienced pain specialist physicians around Australia.
Intervention code [1] 315181 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320930 0
Change in mean pain intensity score (VAS) from baseline (pre-systemic opioid medication wean, if required)
Timepoint [1] 320930 0
4-months post-implant
Secondary outcome [1] 373379 0
Change in mean pain intensity score (VAS) from baseline after systemic opioid medication wean to a dose of 20mg/day or less (morphine equivalent)
Timepoint [1] 373379 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [2] 373380 0
Change in mean quality of life score (EQ-5D) from baseline
Timepoint [2] 373380 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [3] 373381 0
Change in mean Brief Pain Inventory (BPI) from baseline
Timepoint [3] 373381 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [4] 373382 0
Change in mean health status score (SF-36) from baseline
Timepoint [4] 373382 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [5] 373383 0
Change in systemic opioid dose (pre-opioid wean, if required) from baseline
Timepoint [5] 373383 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [6] 373384 0
Patient Global Impression of Change (PGIC)
Timepoint [6] 373384 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [7] 373385 0
Clinician Global Impression of Change (CGIC)
Timepoint [7] 373385 0
1-, 4-, 6-, 12-months post-implant
Secondary outcome [8] 373678 0
Participant-reported adverse events (e.g.: pain at implant site, infection, headaches, respiratory depression, nausea, drowsiness)
Timepoint [8] 373678 0
1-, 4-, 6-, 12-months post-implant

Eligibility
Key inclusion criteria
- Appropriate candidate for TDD therapy
- Failed SCS within the last 5 years prior to enrolment
- If currently on systemic opioid medication, be willing to taper medication to 20mg or lower (morphine equivalent) per day prior to implant
- Be willing to cease use of any SCS/PNS device for study duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical condition or pain in other area(s), that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints according to the Investigator
- Meets any contraindication for pump implantation

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
Multi-centre
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise all subject baseline and outcome data collected during the study. Continuous variables will be summarised using mean, standard deviations, and ranges. Estimates, 95% confidence intervals and statistical significance (against a significance level of p=0.05) will be calculated for endpoints where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2019
Actual
24/10/2019
Date of last participant enrolment
Anticipated
Actual
31/03/2021
Date of last data collection
Anticipated
6/03/2022
Actual
3/02/2022
Sample size
Target
10
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment postcode(s) [1] 27382 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 27383 0
4000 - Brisbane
Recruitment postcode(s) [3] 27384 0
3199 - Frankston
Recruitment postcode(s) [4] 27385 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 303446 0
Commercial sector/Industry
Name [1] 303446 0
Medtronic
Country [1] 303446 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Genesis Research Services
Address
220 Denison Street, Broadmeadow, NSW 2292
Country
Australia
Secondary sponsor category [1] 303500 0
None
Name [1] 303500 0
Address [1] 303500 0
None
Country [1] 303500 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303979 0
Bellberry Limited
Ethics committee address [1] 303979 0
Ethics committee country [1] 303979 0
Australia
Date submitted for ethics approval [1] 303979 0
06/08/2019
Approval date [1] 303979 0
11/09/2019
Ethics approval number [1] 303979 0
2019-08-686

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

Contacts
Principal investigator
Name 95442 0
Dr Marc Russo
Address 95442 0
Genesis Research Services Pty Ltd
220 Denison Street, Broadmeadow, NSW 2292
Country 95442 0
Australia
Phone 95442 0
+61 02 49851860
Fax 95442 0
+61 02 49622046
Email 95442 0
pi@genesisresearchservices.com
Contact person for public queries
Name 95443 0
Emily Allard
Address 95443 0
Genesis Research Services Pty Ltd
220 Denison Street, Broadmeadow, NSW 2292
Country 95443 0
Australia
Phone 95443 0
+61 02 49851860
Fax 95443 0
+61 02 49622046
Email 95443 0
r.manager@genesisresearchservices.com
Contact person for scientific queries
Name 95444 0
Emily Allard
Address 95444 0
Genesis Research Services Pty Ltd
220 Denison Street, Broadmeadow, NSW 2292
Country 95444 0
Australia
Phone 95444 0
+61 02 49851860
Fax 95444 0
+61 02 49622046
Email 95444 0
r.manager@genesisresearchservices.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plan to make individual data available in accordance with original data management plans


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3697Informed consent form    378096-(Uploaded-08-08-2019-15-59-11)-Study-related document.docx
3991Ethical approval    Letter of ethical approval available 378096-(Uploaded-18-10-2023-08-22-32)-Study-related document.pdf



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.