An interventional study of Spinal Cord Stimulation and Conventional Medical Management in Chronic Low-Back Pain, Refractory Pain and Neuropathic Pain, sponsored by Abbott Medical Devices. Completed at 30 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate the efficacy of BurstDR dorsal column stimulation, compared with conventional medical management, in improving pain and back-related physical function in subjects suffering with chronic, refractory axial low back pain with a neuropathic component, who have not had lumbar spine surgery and for whom surgery is not an option.
A prospective, multi-center, randomized, controlled clinical study with an optional crossover component. The study is designed to evaluate the efficacy of BurstDR SCS in the treatment of chronic axial low back pain with a neuropathic component, compared to conventional medical management (CMM).
Subjects will be followed in-clinic at 1,3, 6, 9, 12, 18 and 24 months and via phone call or optional clinic visit at 15- and 21-months. The primary endpoint will be assessed at the 6-month follow-up visit. Upon completion of the 6-month follow-up visit, subjects who are dissatisfied with therapy and receiving inadequate improvement with their treatment assignment will be allowed to cross-over to the other treatment arm, if desired.
The study will enroll up to 270 patients at up to 30 sites. Subjects will be randomized in a 3:2 fashion to yield approximately 200 evaluable subjects for the primary endpoint analysis.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 270 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →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.
Counted across the registry records on this site, refreshed daily.
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:
Back pain is due to any of the following:
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator
Device: Spinal Cord Stimulation
CMM consists of an array of therapies including, but not limited to structured physical therapy, medications, injections, and complementary and alternative medicine (e.g. acupuncture, massage therapy)
Other: Conventional Medical Management
Utilization of BURSTDR stimulation
Also known as: Proclaim XR IPG
Assessing type of CMM, location and frequency.
Also known as: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
The Difference in Responders Between Both Groups
Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).
Time frame: 6 Months
Measure of Composite Responder Rate
Composite Responder rate describes percentage of patients who responded on NRS OR ODI improvements (percentage of patients who report at least ≥13 change on ODI from baseline OR a ≥ 50% decrease in NRS from baseline).
Time frame: 6 Months
Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months
The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain (the worst pain imaginable). Lower scores indicate pain reduction. The data is expressed as relative change (%).
Time frame: Baseline to 6 Months
Oswestry Disability Index (ODI) Change From Baseline to 6 Months
The Oswestry Disability Index questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. An interpretation of 0% to 20% means minimal disability;21% to 40% means moderate disability; 41% to 60% means severe disability; 61% to 80% means crippled; and 81%-100% means bed-bound patients. Lower scores indicate less disability.
Time frame: Baseline to 6 Months
Pain Catastrophizing Scale (PCS) Responder Rate
The Pain Catastrophizing Scale questionnaire is a three part question that measures three pain domains: 1. Rumination (e.g. "I can´t stop thinking about how much it hurts") 2. Magnification (e.g. "I´m afraid that something serious might happen") 3. Helplessness (e.g. "There is nothing I can do to reduce the intensity of my pain"). The Pain Catastrophizing Scale questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The questionnaire includes 13 statements describing different thoughts and feelings that may be associated with pain. Using the scale 0-4 (0- not at all; 1- to a slight degree; 2- to a moderate degree; 3- to a great degree; and 4- all the time), the patients are expected to indicate the degree to which they have these thoughts and feelings when they're experiencing pain. Lower scores indicate less catastrophizing thoughts.
Time frame: 6 Months
Patient Global Impression of Change (PGIC) Responder Rate
PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The percentage of patients who reported "very much improved," or "much improved," are presented.
Time frame: 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months
The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome). Pain Interferences: Normal: \<55; Mild: 55 - 60; Moderate: 60 -70; and Severe: \>70.
Time frame: Baseline to 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months
The PROMIS-29 physical function sub-scale includes 4 questions. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome). Physical function- Normal: \>45; Mild: 40 - 45; Moderate: 30 - 40; and Severe: \>30.
Time frame: Baseline to 6 Months
The first patient enrolled in July 2020 was screen failed. Post that, the study enrolled the first subject in September, 2020. In total, 269 subjects were randomized at 30 investigational sites: 162 to SCS and 107 to CMM.
| Milestone | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Started | 162 | 107 |
| The number of subjects implanted | 115 | 103 |
| Cross over to alternate arm | 0 | 70 |
| Completed | 104 | 85 |
| Not completed | 58 | 22 |
| Withdrew: Withdrawal by subject | 16 | 14 |
| Withdrew: Unsuccessful trial | 17 | 0 |
| Withdrew: Subject participation terminated by investigator | 12 | 3 |
| Withdrew: Ipg/lead(s) explanted but not replaced | 2 | 0 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Death | 3 | 0 |
| Withdrew: Inclusion/exclusion | 2 | 1 |
| Withdrew: Subject became pregnant | 1 | 1 |
| Withdrew: Patient diagnosed with oral cancer, needs to undergo radiation and chemo | 0 | 1 |
| Withdrew: Withdrawn at sponsor's request | 1 | 0 |
| Withdrew: Subject failed to comply with the protocol requirements | 1 | 0 |
| Milestone | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Started | 104 | 85 |
| Completed | 94 | 54 |
| Not completed | 10 | 31 |
| Withdrew: Withdrawal by subject | 3 | 13 |
| Withdrew: Unsuccessful trial | 0 | 7 |
| Withdrew: Ipg/lead(s) explanted but not replaced | 2 | 4 |
| Withdrew: Subject participation terminated by investigator | 2 | 2 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Patient was withdrawn due to study timelines | 0 | 1 |
| Withdrew: Patient's health significantly declined | 0 | 1 |
| Withdrew: Subject had back surgery on march 1st | 0 | 1 |
| Withdrew: Subject failed to comply with the protocol requirements | 0 | 1 |
Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).
| participants | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| The Difference in Responders Between Both Groups | 87 | 5 |
Composite Responder rate describes percentage of patients who responded on NRS OR ODI improvements (percentage of patients who report at least ≥13 change on ODI from baseline OR a ≥ 50% decrease in NRS from baseline).
| participants | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Measure of Composite Responder Rate | 93 | 13 |
The numeric rating scale (NRS) is a verbal or written determination of a pain level on a scale from 0 to 10, in which 0 represents no pain and 10 represents excruciating pain (the worst pain imaginable). Lower scores indicate pain reduction. The data is expressed as relative change (%).
| percent change | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months | 69.7 ± 24.9 | 5.6 ± 21.3 |
The Oswestry Disability Index questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. An interpretation of 0% to 20% means minimal disability;21% to 40% means moderate disability; 41% to 60% means severe disability; 61% to 80% means crippled; and 81%-100% means bed-bound patients. Lower scores indicate less disability.
| units on a scale | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Oswestry Disability Index (ODI) Change From Baseline to 6 Months | 29.4 ± 18.8 | 0.7 ± 13.0 |
The Pain Catastrophizing Scale questionnaire is a three part question that measures three pain domains: 1. Rumination (e.g. "I can´t stop thinking about how much it hurts") 2. Magnification (e.g. "I´m afraid that something serious might happen") 3. Helplessness (e.g. "There is nothing I can do to reduce the intensity of my pain"). The Pain Catastrophizing Scale questionnaire will be completed during selected clinical site visits via the electronic data acquisition portal. These questionnaires will be used for the assessment of study endpoints. The questionnaire includes 13 statements describing different thoughts and feelings that may be associated with pain. Using the scale 0-4 (0- not at all; 1- to a slight degree; 2- to a moderate degree; 3- to a great degree; and 4- all the time), the patients are expected to indicate the degree to which they have these thoughts and feelings when they're experiencing pain. Lower scores indicate less catastrophizing thoughts.
| participants | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Pain Catastrophizing Scale (PCS) Responder Rate | 90 | 19 |
PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The percentage of patients who reported "very much improved," or "much improved," are presented.
| participants | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Patient Global Impression of Change (PGIC) Responder Rate | 77 | 2 |
The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome). Pain Interferences: Normal: \<55; Mild: 55 - 60; Moderate: 60 -70; and Severe: \>70.
| scores on a scale | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months | 17.9 ± 11.3 | 0.9 ± 9.3 |
The PROMIS-29 physical function sub-scale includes 4 questions. The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome). Physical function- Normal: \>45; Mild: 40 - 45; Moderate: 30 - 40; and Severe: \>30.
| scores on a scale | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months | 27.8 ± 24.4 | 1.4 ± 13.6 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Cord Stimulation (SCS) | 5/162 (3.1%) | 7/162 (4.3%) | 17/162 (10.5%) |
| Conventional Medical Management (CMM) | 0/107 (0%) | 0/107 (0%) | 0/107 (0%) |
| Event | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| InfectionInfections and infestations | 2/162 | 0/107 |
| Digoxin ToxicityInjury, poisoning and procedural complications | 1/162 | 0/107 |
| Bladder RuptureRenal and urinary disorders | 1/162 | 0/107 |
| Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 1/162 | 0/107 |
| Numbness Below The Level Of ImplantSurgical and medical procedures | 1/162 | 0/107 |
| Post Surgical PainSurgical and medical procedures | 1/162 | 0/107 |
| Event | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) |
|---|---|---|
| Changes In Stimulation Or Reduced Pain Relief Due To Lead MigrationProduct Issues | 4/162 | 0/107 |
| InfectionInfections and infestations | 3/162 | 0/107 |
| Persistent Pain At The IPG SiteGeneral disorders | 3/162 | 0/107 |
| Sleeping Issues And Weird DreamsGeneral disorders | 1/162 | 0/107 |
| Cerebrospinal Fluid (CSF) LeakageNervous system disorders | 1/162 | 0/107 |
| Damage To The IPG Or LeadsGeneral disorders | 1/162 | 0/107 |
| Dermatitis And DesquamationSkin and subcutaneous tissue disorders | 1/162 | 0/107 |
| Implant MigrationGeneral disorders | 1/162 | 0/107 |
| Movement Or Vibration Of The IPG Or LeadsGeneral disorders | 1/162 | 0/107 |
| Skin ReactionSkin and subcutaneous tissue disorders | 1/162 | 0/107 |
The Overall Number of Baseline Participants includes only the implanted patients.
| Age, Continuous(years) | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) | Total |
|---|---|---|---|
| Mean | 58.1 ± 13.0 | 59.1 ± 12.4 | 58.5 ± 12.8 |
| Sex: Female, Male(Participants) | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) | Total |
|---|---|---|---|
| Female | 69 | 52 | 121 |
| Male | 46 | 51 | 97 |
| Race/Ethnicity, Customized(Participants) | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) | Total |
|---|---|---|---|
| White | 96 | 84 | 180 |
| Black or African American | 7 | 3 | 10 |
| Asian | 0 | 7 | 7 |
| American Indian or Alaska Native | 1 | 2 | 3 |
| Declined or Unable to Disclose Due to Local Regulation | 10 | 6 | 16 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| More than one race (One subject having both White and Asian race) | 0 | 1 | 1 |
| Pain Numeric Rating Scale (NRS)(scores on a scale) | Spinal Cord Stimulation (SCS) | Conventional Medical Management (CMM) | Total |
|---|---|---|---|
| Lower Back | 7.7 ± 1.2 | 7.9 ± 1.1 | 7.8 ± 1.2 |
| Right Leg | 2.7 ± 2.6 | 3.1 ± 2.8 | 3.0 ± 2.7 |
| Left Leg | 2.8 ± 2.7 | 3.0 ± 2.8 | 3.0 ± 2.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2020 to primary completion in Aug 2022, 24 months.
Results were first posted in Jun 2024, 1 year 9 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 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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