Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01550562




Registration number
NCT01550562
Ethics application status
Date submitted
15/02/2012
Date registered
12/03/2012
Date last updated
29/04/2021

Titles & IDs
Public title
Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation
Scientific title
Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain
Secondary ID [1] 0 0
A7002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Boston Scientific Precision Plus spinal cord stimulation therapy

Placebo comparator: Sham Stimulation - Sham subthreshold spinal cord stimulation therapy

Active comparator: Treatment 1 - subthreshold spinal cord stimulation therapy

Experimental: Treatment 2 - subthreshold spinal cord stimulation therapy


Treatment: Devices: Boston Scientific Precision Plus spinal cord stimulation therapy
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain Relief
Timepoint [1] 0 0
4,8,and 12 days post temporary lead(s) implantation
Secondary outcome [1] 0 0
Pain Relief Responder Rate
Timepoint [1] 0 0
4,8,and 12 days post temporary lead(s) implantation
Secondary outcome [2] 0 0
Leg Pain Reduction
Timepoint [2] 0 0
4,8,and 12 days post temporary lead(s) implantation
Secondary outcome [3] 0 0
Disability
Timepoint [3] 0 0
4,8,and 12 days post temporary lead(s) implantation
Secondary outcome [4] 0 0
Percent Pain Relief
Timepoint [4] 0 0
4,8,and 12 days post temporary lead(s) implantation
Secondary outcome [5] 0 0
Quality of Life, as Measured by EQ-5D-5L
Timepoint [5] 0 0
4,8,and 12 days post temporary lead(s) implantation

Eligibility
Key inclusion criteria
* Chronic intractable pain of the trunk and/or limbs
* Documented history of trunk and/or limb pain of at least 180 days
* Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
* Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
* If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
* Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
* Subject is able to independently read and complete all questionnaires and/or assessments provided in English
* 18 years of age or older when written informed consent is obtained
* Subject signs a valid, Ethics Committee-approved informed consent form (ICF) provided in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to operate the PrecisionPlus™ system
* Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
* Is a high surgical risk
* Is diabetic
* Is immunocompromised
* Currently on any anticoagulant medications that cannot be discontinued during perioperative period
* Untreated major depression or untreated generalized anxiety disorder
* Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
* Diagnosed with any major psychiatric disorder not specifically listed in previous two exclusion criterion
* Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
* Current abuse of alcohol or illicit drugs
* Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
* Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
* Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pump, etc) or pacemaker or implantable cardiac defibrillator
* Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result document)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Hunter Pain Clinic - Newcastle
Recruitment postcode(s) [1] 0 0
2292 - Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kay Adair
Address 0 0
Boston Scientific Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01550562