Pain, IntractableBOLDNCT03350256

BurstDR™ micrOdosing stimuLation in De-novo Patients

A study testing Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. in people with Pain, Intractable and Pain, Back, run by Abbott Medical Devices at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Pain, Intractable, Pain, Back
What is being tested?: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 30 Oct 2017to 2 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is able to provide informed consent to participate in the study;
Subject diagnosed with chronic intractable pain associated with back and/or limbs;
Subject is 18 years of age or older;
Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;
Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;

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Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;
Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study

Who cannot join

Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
Subject is currently participating in a clinical investigation that includes an active treatment arm;
Subject has been implanted with or participated in a trial period for a neurostimulation system;
Subject has an infusion pump;
Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;

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Subject is immunocompromised;
Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);
Subject has history of cancer requiring active treatment in the last 12 months;
Subject has an existing medical condition that is likely to require the use of diathermy in the future;
Subject has documented history of allergic response to titanium or silicone;
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection;
Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);
Subject has life expectancy of less than 6 months;
Subject is involved in an injury claim under current litigation

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

OnSite Clinical Solutions
Asheville, North Carolina, 28803
Premier Pain Solutions
Charleston, West Virginia, 25301
Ambulatory Surgery Center of Killeen
Killeen, Texas, 76542
Nevada advanced pain specialists
Reno, Nevada, 89511
Thrive Clinic
Santa Rosa, California, 95403

Other trials in United States

About this study

The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.

Read the detailed description

Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.

In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.

Conditions: Pain, Intractable, Pain, Back
Being tested: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
Medical subject headings: Pain, Intractable, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.Device
BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.

Study groups in NCT03350256
Study group	Role	What they receive
Microdosing group	Experimental	Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Receives: Device: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Measured: baseline and 1 week after trial lead implant (trial stimulation)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Measured: Baseline and 1 month follow up visit
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Measured: Baseline and 3 month follow up visit
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Measured: Baseline and 6 month follow up visit

Secondary outcomes (12)

Change in Quality of Life Between Baseline and Trial Stimulation
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Quality of Life Between Baseline and Follow up 1
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: Baseline and 1 month follow up visit
Change in Quality of Life Between Baseline and Follow up 2
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: Baseline and 3 month follow up visit
Change in Quality of Life Between Baseline and Follow up 3
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Measured: Baseline and 6 month follow up visit
Change in Disability Index Between Baseline and Trial Stimulation
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Disability Index Between Baseline and and Follow up 1
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: Baseline and 1 month follow up visit
Change in Disability Index Between Baseline and and Follow up 2
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: Baseline and 3 month follow up visit
Change in Disability Index Between Baseline and and Follow up 3
questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Measured: Baseline and 6 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Measured: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Measured: Baseline and 1 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2
Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Measured: Baseline and 3 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
Measured: Baseline and 6 month follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20172 Jul 2019

First posted22 Nov 2017
Study start30 Oct 2017
Primary completion2 Jul 2019
Study completion2 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain, IntractableStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03350256
Sponsor's protocol ID: SJM-CIP-10215
Acronym: BOLD
Status last verified: Mar 2020
First submitted: 10 Nov 2017
Last updated: 19 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
Spinal Cord Injury, Neuropathic Pain
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
Intractable Pain, Palliative Care

All Pain, Intractable trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BurstDR™ micrOdosing stimuLation in De-novo Patients
ClinicalTrials.gov ID: NCT03350256
Acronym / sponsor ID: BOLD / SJM-CIP-10215
Conditions: Pain, Intractable, Pain, Back
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 30 Oct 2017 (actual)
Primary completion: 2 Jul 2019 (actual)
Study completion: 2 Jul 2019 (actual)
First posted: 22 Nov 2017 (actual)
Results: Posted 19 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.

Detailed description

Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Microdosing group	Experimental	Device: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subject is able to provide informed consent to participate in the study;
Subject diagnosed with chronic intractable pain associated with back and/or limbs;
Subject is 18 years of age or older;
Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;
Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;

Key exclusion criteria (15 listed)

Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
Subject is currently participating in a clinical investigation that includes an active treatment arm;
Subject has been implanted with or participated in a trial period for a neurostimulation system;
Subject has an infusion pump;
Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.	Device	Microdosing group

Primary outcome

Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation
Time frame: baseline and 1 week after trial lead implant (trial stimulation)
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1
Time frame: Baseline and 1 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2
Time frame: Baseline and 3 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3
Time frame: Baseline and 6 month follow up visit
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

12 secondary outcomes

Change in Quality of Life Between Baseline and Trial Stimulation
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Quality of Life Between Baseline and Follow up 1
Time frame: Baseline and 1 month follow up visit
Change in Quality of Life Between Baseline and Follow up 2
Time frame: Baseline and 3 month follow up visit
Change in Quality of Life Between Baseline and Follow up 3
Time frame: Baseline and 6 month follow up visit
Change in Disability Index Between Baseline and Trial Stimulation
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Disability Index Between Baseline and and Follow up 1
Time frame: Baseline and 1 month follow up visit
Change in Disability Index Between Baseline and and Follow up 2
Time frame: Baseline and 3 month follow up visit
Change in Disability Index Between Baseline and and Follow up 3
Time frame: Baseline and 6 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation
Time frame: Baseline and 1 week after trial lead implant (trial stimulation)
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1
Time frame: Baseline and 1 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2
Time frame: Baseline and 3 month follow up visit
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3
Time frame: Baseline and 6 month follow up visit

Results and safety

Results posted to the registry on 19 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Microdosing Group	60	24

Primary outcome: Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation

Time frame: baseline and 1 week after trial lead implant (trial stimulation). Mean (Standard Deviation). Unit: units on a scale

Measure	Microdosing Group n = 47
Value	-46.28 (23.83)

Population analysed: Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects

Primary outcome: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1

Time frame: Baseline and 1 month follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Microdosing Group n = 28
Value	-41.07 (24.74)

Population analysed: Change in VAS score between baseline and 1 month follow up missing data for 2 subjects

Primary outcome: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2

Time frame: Baseline and 3 month follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Microdosing Group n = 25
Value	-36.56 (29.53)

Population analysed: Change in VAS between baseline and 3 month follow up missing data for 2 subject

Primary outcome: Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3

Time frame: Baseline and 6 month follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Microdosing Group n = 24
Value	-36.62 (29.54)

Population analysed: Change in VAS score between baseline and 6 months visit

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to completion of the study at 6 month follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Microdosing Group	2 of 60 (3.3%)	3 of 60 (5%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pain, Intractable

RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Recruiting
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
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Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
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RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
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Not yet recruitingPhase 1/2
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy R Deer, MD principal investigator

The Center for Pain Relief

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation (time frame: baseline and 1 week after trial lead implant (trial stimulation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.