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Trial registered on ANZCTR


Registration number
ACTRN12614000684628
Ethics application status
Approved
Date submitted
13/06/2014
Date registered
27/06/2014
Date last updated
5/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, feasibility study evaluating the safety and effectiveness of Saluda Medical’s Neurostimulation Technology incorporating neural response measurement and feedback control to treat patients with chronic pain in an extended trial
Scientific title
Effectiveness of feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects in an extended trial
Secondary ID [1] 284734 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 292087 0
Condition category
Condition code
Anaesthesiology 292429 292429 0 0
Pain management
Neurological 292430 292430 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Potential participants will be patients of the Investigator who have decided to trial neurostimulation during a consultation discussion regarding treatment options for their pain. Trialling Spinal cord stimulation involves implanting one or two spinal lead which normally takes less than an hour. Minimal sedation will be used during the procedure. The patient needs to be alert and communicative ensuring intraoperative testing to ensure proper positioning of the leads.
If they patient decided to trial the spinal cord stimulation, they will then be told about the study and given the Participant Information Sheet and Consent Form to take home and read. If they agree to participate in the study, they will be tested using experimental stimulators. This experimental neurostimulator will either be a multi-channel system (MCS) used in the operating theatre and clinic, or an external trial system (ETS) that they will wear at home. A second form of the ETS is the body worn system (BWS) that would only be used for testing in the clinic for ambulatory tests. Following the minimum 3 day trial with their commercial stimulation, patients will be programed with feedback control and they will go home with this program using ETS. Patients can have ETS for up to 25 days. The intensity of stimulation automatically adjusted to the comfort level of the patient using the feedback control loop. Patient can choose to have the stimulation ON all the time during the trial or for some certain time during day. In each follow-up visit (every 5-7 days), their wound will be checked and they will be asked to answer some basic questions about their pain level and their experience with stimulation. At the final visit, ETS will be disconnected from the lead and lead will be removed by a clinician.
Patients may have another visit for some neurophysiological measurements using the experimental stimulators. This is an optional visit which can be done at any time.
Intervention code [1] 289517 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292288 0
Evaluate the outcomes of feedback control with respect to pain reduction on 5-point Likert scales.
Timepoint [1] 292288 0
Clinic Visit (from 1 to 25 days after programmed with feedback control)
Primary outcome [2] 292440 0
Evaluate the outcomes of feedback control with respect to stimulation side effects (overstimulation or other unwanted stimulation) on 5-point Likert scales.
Timepoint [2] 292440 0
Clinic Visit (from 1 to 25 days after programmed with feedback control)
Secondary outcome [1] 308648 0
All reported adverse events.
The adverse event can be any change, undesired, noxious or pathological in a patient or participant illustrated by signs, symptoms and /or laboratory changes that occur during a clinical trial, whether or not considered drug/treatment related.
If adverse experiences occur, the first concern will be the safety of the patient. Appropriate medical intervention will be made. Any device related adverse experiences or complications observed by the investigator or reported by the patients will be recorded in the appropriate section of the patient's case report forms in accordance with NSW Health GL2010_014.
Timepoint [1] 308648 0
Clinic Visit (from 1 to 25 days after programmed with feedback control)
Secondary outcome [2] 308947 0
number of button pushes: any button pushes will b e stored in the device and at the end of the trial will be retrieved for further process.
Timepoint [2] 308947 0
end of trial (from 1 to 25 days after programmed with feedback control)
Secondary outcome [3] 308948 0
Brief pain inventory: pain relief, pain quality and patient perception of pain collected using 0 to 10 numeric scale.
Timepoint [3] 308948 0
Data will be collected before intra-operative procedure, after 3-days commercial trial and at the final visit (from 1 to 25 days after programmed with feedback control)
Secondary outcome [4] 308949 0
Comparison of pain and paresthesia maps.
Data on the area of pain and paresthesia coverage will be collected by asking patient to highlight the areas on body map drawing.
the comparison between these two maps show the percentage of pain coverage by paresthesia and any changes on the followup visits.
Timepoint [4] 308949 0
Pain map will be collected before intra-operative procedure and paresthesia map data will be collected in every followup visits (every 5 to 7 days for up to 4 visits).
Secondary outcome [5] 308950 0
Neural response to changes in stimulation frequency, amplitude, pulse width, pulse shape, pulse sequence and electrode configuration. The Patient threshold, comfort and maximum level of stimulation as well as parethesia sensation and pain coverage will be collected in a form for each experiment for further research.
Timepoint [5] 308950 0
this experiment can be done in one of the follow-up visits(every 5 to 7 days up to 4 visits).
Secondary outcome [6] 309027 0
Visual Analogue scale: is a measure of pain. patient will be asked to score his pain on a 10-cm line from no pain to worst pain by drawing a mark on the line.
Timepoint [6] 309027 0
Data will be collected before intra-operative procedure, after 3-days commercial trial and at the final visit (from 1 to 25 days after programmed with feedback control).
Secondary outcome [7] 309028 0
SF-36: provides scores on a 0 to 100 scale for eight dimensions of general health (physical function, social function, mental health, general health perception, pain, vitality, role limitations due to physical problems and role limitations due to mental health problems) as well as two summary scales (physical and mental component scales).
Timepoint [7] 309028 0
Data will be collected before intra-operative procedure, after 3-days commercial trial and at the final visit (from 1 to 25 days after programmed with feedback control).
Secondary outcome [8] 309029 0
EQ-5D: The EQ-5D questionnaire captures health-related quality of life data in five key areas.
Timepoint [8] 309029 0
Data will be collected before intra-operative procedure, after 3-days commercial trial and at the final visit (from 1 to 25 days after programmed with feedback control).

Eligibility
Key inclusion criteria
Patients enrolled in this study must meet the following inclusion criteria:
1. Have been diagnosed with chronic, intractable pain, which has been refractory to conservative therapy for a minimum of 3 months.
2. Have been approved to undergo a trial of neural stimulation. Neural stimulation can include spinal cord stimulation (cervical, thoracic or sacral), peripheral nerve stimulation (such as occipital or sacral nerves), dorsal root, or dorsal root ganglion.
3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4. Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
5. Be 18 years of age or older at the time of enrolment
6. Be willing and capable of giving written informed consent
7. Be willing and able to comply with study-related requirements, procedures, and visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients enrolled in this study must not meet the following exclusion criteria:
1. Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
3. Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
4. Have a diagnosis of scoliosis that precludes lead placement in epidural space (for SCS patients only)
5. Have an existing drug pump and/or neural stimulation system or another active implantable device such as a pacemaker
6. Have a condition currently requiring or likely to require the use of MRI or diathermy
7. Have pain due to a malignant disease
8. Have a life expectancy of less than 1 year
9. Have an active systemic or local infection
10. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
11. Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
12. Have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
13. Be concomitantly participating in another clinical study
14. Be involved in an injury claim under current litigation

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)
Patients with chronic pain who have been selected by their doctor to get a trial of spinal cord stimulation will be invited by the doctor to participate in the study. All patients receive SCS with feedback. There is not randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This study is not intended to be used to show statistical significance between feedback and non-feedback but is intended to assess various outcome measures to determine their sensitivity in examining the effects of feedback on both pain and side effects (as well as other quality of life measures). The study will help to determine the usefulness of feedback using ECAPs by showing a reduction in side effects while maintaining or improving pain relief.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2014
Actual
14/10/2014
Date of last participant enrolment
Anticipated
1/06/2018
Actual
28/06/2017
Date of last data collection
Anticipated
Actual
28/06/2017
Sample size
Target
25
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2541 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 8228 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 289352 0
Commercial sector/Industry
Name [1] 289352 0
Saluda Medical Pty Ltd
Country [1] 289352 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Saluda Medical Pty Ltd
Address
Level1
407 Pacific Highway Artarmon NSW 2064
Country
Australia
Secondary sponsor category [1] 288036 0
None
Name [1] 288036 0
Address [1] 288036 0
Country [1] 288036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291121 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 291121 0
Ethics committee country [1] 291121 0
Australia
Date submitted for ethics approval [1] 291121 0
28/04/2014
Approval date [1] 291121 0
04/10/2014
Ethics approval number [1] 291121 0
HREC/14/HAWKE/129

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

Contacts
Principal investigator
Name 48946 0
Prof Michael Cousins
Address 48946 0
Pain Management and Research Institute
Douglas Building
Royal North Shore Hospital
St Leonard NSW 2065
Country 48946 0
Australia
Phone 48946 0
+61 2 94631638
Fax 48946 0
Email 48946 0
Michael.Cousins@health.nsw.gov.au
Contact person for public queries
Name 48947 0
Linda Critchley
Address 48947 0
Pain Management & Research Institute
Royal North Shore Hospital
St Leonards NSW 2065
Country 48947 0
Australia
Phone 48947 0
+61 2 94631533
Fax 48947 0
Email 48947 0
Linda.Critchley@health.nsw.gov.au
Contact person for scientific queries
Name 48948 0
Nastaran Hesam Shariati
Address 48948 0
Saluda Medical
Level 1
407 Pacific Highway Artarmon NSW 2064
Country 48948 0
Australia
Phone 48948 0
+61284058707
Fax 48948 0
Email 48948 0
nastaran.shariati@saludamedical.com

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.