An interventional study of Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. in Pain, Intractable and Pain, Back, sponsored by Abbott Medical Devices. Completed at 5 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 39 studies in Pain, Intractable with a site in United States — 5 open to participants now, 5 under way, none of them phase 3. Pain, Intractable · United States.
Among the 39 studies in Pain, Intractable with a site in United States, this one is the 18th largest by enrollment of the 32 interventional ones that give a count, is one of 2 that started in 2017, is one of 20 with no phase, and was the 21st registered.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →5 of the 39 studies in Pain, Intractable with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 11 Pain, Intractable studies recruiting now, 8 (73%) set no upper age limit and 1 (9%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 4 · Phase 3 2 · Phase 4 4
First in 2003; this study’s year is marked. 2 started in 2017.
Median enrollment 65 across the 32 interventional studies, 91 across the 7 observational. Of the 28 that completed or were terminated, 16 (57%) have results posted.
19 of 39 have an industry lead sponsor. The 10 most frequent:
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Abbott Medical Devices has 4 studies filed under Pain, Intractable — fewer than ten, so there is no comparison to draw.
3 of the studies in Pain, Intractable with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02522611National Institute of Neurological Disorders and Stroke (NINDS)Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain | 2026-12-01 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT07190807Boston Scientific CorporationManaging Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control | 2027-11 |
Among the 39 studies in Pain, Intractable with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.
Device: 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.
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 6 month follow up visit
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 6 month follow up visit
Stimulation ON/OFF Ratio
Percentage of patients using each ON/OFF ratio
Time frame: 6 month follow up visit
| Milestone | Microdosing Group |
|---|---|
| Started | 60 |
| Spinal cord stimulation trial | 50 |
| Permanent implant | 35 |
| 1 month follow up | 30 |
| 3 month follow up | 27 |
| 6 month follow up | 24 |
| Completed | 24 |
| Not completed | 36 |
| Withdrew: Inclusion/exclusion violation | 4 |
| Withdrew: Recommended for other therapies | 2 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Non compliance | 2 |
| Withdrew: Denial by insurance | 1 |
| Withdrew: Adverse event | 2 |
| Withdrew: Trial failure | 12 |
| Withdrew: Did not proceed to permanent implant | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Subject moving out of state | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Lack of efficacy | 2 |
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
| units on a scale | Microdosing Group |
|---|---|
| Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation | -46.28 ± 23.83 |
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
| units on a scale | Microdosing Group |
|---|---|
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1 | -41.07 ± 24.74 |
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
| units on a scale | Microdosing Group |
|---|---|
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2 | -36.56 ± 29.53 |
Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)
| units on a scale | Microdosing Group |
|---|---|
| Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3 | -36.62 ± 29.54 |
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)
| score on a scale | Microdosing Group |
|---|---|
| Change in Quality of Life Between Baseline and Trial Stimulation | 0.172 ± 0.1625 |
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)
| score on a scale | Microdosing Group |
|---|---|
| Change in Quality of Life Between Baseline and Follow up 1 | 0.148 ± 0.121 |
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)
| score on a scale | Microdosing Group |
|---|---|
| Change in Quality of Life Between Baseline and Follow up 2 | 0.106 ± 0.209 |
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)
| score on a scale | Microdosing Group |
|---|---|
| Change in Quality of Life Between Baseline and Follow up 3 | 0.148 ± 0.136 |
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
| score on a scale | Microdosing Group |
|---|---|
| Change in Disability Index Between Baseline and Trial Stimulation | -17.6 ± 18.15 |
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
| score on a scale | Microdosing Group |
|---|---|
| Change in Disability Index Between Baseline and and Follow up 1 | -12.76 ± 14.5 |
questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
| score on a scale | Microdosing Group |
|---|---|
| Change in Disability Index Between Baseline and and Follow up 2 | -17 ± 19.1 |
questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
| score on a scale | Microdosing Group |
|---|---|
| Change in Disability Index Between Baseline and and Follow up 3 | -15.5 ± 16.6 |
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
| score on a scale | Microdosing Group |
|---|---|
| Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation | -8.98 ± 12.3 |
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
| score on a scale | Microdosing Group |
|---|---|
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 1 | -12.17 ± 12.83 |
Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
| score on a scale | Microdosing Group |
|---|---|
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 2 | -13.32 ± 14.38 |
Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)
| score on a scale | Microdosing Group |
|---|---|
| Change in Pain Catastrophizing Scale Between Baseline and Follow up 3 | -13.42 ± 12.68 |
Percentage of patients using each ON/OFF ratio
| Participants | Microdosing Group |
|---|---|
| subjects using 360 seconds OFF intervals | 11 |
| subjects using 240 seconds OFF intervals | 3 |
| subjects using 150 seconds OFF intervals | 3 |
| subjects using 120 seconds OFF intervals | 3 |
| subjects using 90 seconds OFF intervals | 4 |
Collected over From enrollment to completion of the study at 6 month follow up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microdosing Group | 0/60 (0%) | 2/60 (3.3%) | 3/60 (5%) |
| Event | Microdosing Group |
|---|---|
| Subject fractured <1 vertebrae (compression) and was hospitalized overnightInjury, poisoning and procedural complications | 1/60 |
| Hospitalization for abdominal painGeneral disorders | 1/60 |
| Event | Microdosing Group |
|---|---|
| Trial lead migrationInjury, poisoning and procedural complications | 3/60 |
Included subjects that started the SCS trial (50). One subjects had missing demographic data
| Age, Continuous(years) | Microdosing Group |
|---|---|
| Mean | 56.8 ± 3.95 |
| Sex: Female, Male(Participants) | Microdosing Group |
|---|---|
| Female | 30 |
| Male | 19 |
| Race and Ethnicity Not Collected(Participants) | Microdosing Group |
|---|
| Region of Enrollment(participants) | Microdosing Group |
|---|---|
| United States | 49 |
| duration of pain(years) | Microdosing Group |
|---|---|
| Mean | 9.98 ± 3.31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2019, 20 months.
Results were first posted in Mar 2020, 8 months after primary completion.
Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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