Chronic Low-Back PainNCT04479787
Spinal Cord Stimulation vs. Medical Management for Low Back Pain (DISTINCT)
A study testing Spinal Cord Stimulation and Conventional Medical Management in people with Chronic Low-Back Pain and Refractory Pain, run by Abbott Medical Devices at 30 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain
- What is being tested?
- Spinal Cord Stimulation and Conventional Medical Management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 30 sitesUnited States
- Study dates
- 31 Jul 2020to 26 Feb 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
- Age ≥ 18 years
- Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
- Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
- Patient has not had spine surgery for back or leg pain
- Patient is a candidate for spinal cord stimulation
Show all 9Show fewer
- Low back pain ≥ 6 on Numerical Rating Scale
- Oswestry Disability Index score of ≥ 30%
- Willing and able to comply with the instructions for use, operate the study device, and comply with this Clinical Investigation Plan
Who cannot join
- Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
- Primary complaint of leg pain, or leg pain is greater than back pain
- Back pain is due to any of the following:
- spinal instability defined as > 2 mm translation on radiographic imaging
- visceral causes (e.g., endometriosis or fibroids)
- vascular causes (e.g., aortic aneurysm)
Show all 30Show fewer
- spinal infection (e.g., osteomyelitis)
- inflammation or damage to the spinal cord (e.g. arachnoiditis or syringomyelia)
- tumor or spinal metastases
- Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
- Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
- Neurological deficit (e.g. foot drop)
- Prior lumbar spine surgery or sacroiliac joint fusion
- Patient has used a morphine equivalent daily dose of more than 50 MME in the last 30 days
- Patient is bed bound
- Patients with regular intake of systemic steroids (except inhaled steroids used to treat asthma)
- Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicates lead placement
- Known allergic reaction to implanted materials
- Severe scoliotic deformity (>11 degrees in thoracic or lumbar spine)
- Patient has a history of, or existing intrathecal drug pump
- Patient has previous experience with neuromodulation devices, including a failed trial
- BMI > 40
- Patient is enrolled, or intends to participate, in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by Abbott personnel
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results.
- Failed psychological evaluation
- Suspicion or evidence of untreated mental illness, or substance abuse
- Patient demonstrated 2 or more Waddell's signs of nonorganic behavior
- Patient is in current litigation for back pain/injury, or is currently receiving worker's compensation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to enrollment/baseline visit per site standard test.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Albany Medical Center
Albany, New York, 12208
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010
Coastal Pain & Spinal Diagnostics Medical Group
Carlsbad, California, 92009
Indiana Spine Group
Carmel, Indiana, 46032
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
The Spine & Nerve Center of St Francis Hospital
Charleston, West Virginia, 25301
Saint Louis Pain Consultants
Chesterfield, Missouri, 63017
Chicago Anesthesia Associates
Chicago, Illinois, 60657
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Axis Spine Center
Coeur d'Alene, Idaho, 83815
Northshore University Health System
Evanston, Illinois, 60201
Center for Interventional Pain & Spine
Exton, Pennsylvania, 19341
The Orthopedic Institute
Gainesville, Florida, 32607
Connecticut Orthopedic Specialists
Hamden, Connecticut, 06518
Advanced Pain Care
Henderson, Nevada, 89052
Goodman Campbell Brain & Spine
Indianapolis, Indiana, 45133
Kansas University Medical Center
Kansas City, Kansas, 66160
Napa Valley Orthopedic Medical Group
Napa, California, 94558
Barrow Brain & Spine
Phoenix, Arizona, 85048
Rhode Island Hospital
Providence, Rhode Island, 02903
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Mayo Clinic
Rochester, Minnesota, 55905
Burkhart Research Institute for Orthopaedics
San Antonio, Texas, 78216
Carolina Orthopedics and Neurosurgical Associates
Spartanburg, South Carolina, 29303
Anesthesia Pain Care Consultants
Tamarac, Florida, 33321
Montefiore Medical Center
The Bronx, New York, 10461
Spinal Diagnostics
Tualatin, Oregon, 97062
Banner University Medical Center
Tucson, Arizona, 85724
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20037
About this study
Official title: Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
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.
Read the detailed description
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.
- Conditions
- Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain
- Being tested
- Spinal Cord Stimulation, Conventional Medical Management
- Keywords
- Chronic Low Back Pain, Spinal Cord Stimulation
- Medical subject headings
- Pain, Intractable, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Also called Proclaim XR IPG
Utilization of BURSTDR stimulation
Conventional Medical ManagementOther
Also called Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.
Assessing type of CMM, location and frequency.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation (SCS) | Active comparator | An SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator Receives: Device: Spinal Cord Stimulation |
| Conventional Medical Management (CMM) | Active comparator | 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) Receives: Other: Conventional Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 Months
Secondary outcomes (7)
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).
Measured: 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 (%).
Measured: 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.
Measured: 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:
- Rumination (e.g. "I can´t stop thinking about how much it hurts")
- Magnification (e.g. "I´m afraid that something serious might happen")
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start31 Jul 2020
- Primary completion23 Aug 2022
- Study completion26 Feb 2024
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-Back PainStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Yue, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479787
- Sponsor's protocol ID
- ABT-CIP-10343
- Status last verified
- Jan 2025
- First submitted
- 17 Jul 2020
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Deer T, Gilligan C, Falowski S, Desai M, Pilitsis J, Jameson J, Moeschler S, Heros R, Tavel E, Christopher A, Patterson D, Wahezi S, Weisbein J, Antony A, Funk R, Ibrahim M, Lim C, Wilson D, Fishell M, Scarfo K, Dickerson D, Braun E, Buchanan P, Levy RM, Miller N, Duncan J, Xu J, Candido K, Kreiner S, Fahey ME, Yue J. Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Neuromodulation. 2023 Oct;26(7):1387-1399. doi: 10.1016/j.neurom.2023.07.009. Epub 2023 Aug 28.
PubMed 37642628O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsal Spinal Cord Stimulation vs Medical Management for the Treatment of Low Back Pain (DISTINCT)
- ClinicalTrials.gov ID
- NCT04479787
- Acronym / sponsor ID
- ABT-CIP-10343
- Conditions
- Chronic Low-Back Pain, Refractory Pain, Neuropathic Pain
- Keywords
- Chronic Low Back Pain, Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation (SCS) | Active comparator | Device: Spinal Cord StimulationAn SCS Trial period followed by SCS Implantation with the Abbott Proclaim XR Implantable Pulse Generator |
| Conventional Medical Management (CMM) | Active comparator | Other: Conventional Medical ManagementCMM 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be willing and able to provide written informed consent prior to any clinical investigation-related procedure.
- Age ≥ 18 years
- Patient has chronic (at least 6 months), refractory axial low back pain with a neuropathic component and is not a candidate for spine surgery
- Patient has back pain for ≥ 6 months inadequately responsive to supervised conservative care
- Patient has not had spine surgery for back or leg pain
Key exclusion criteria (30 listed)
- Pathology seen on imaging tests obtained within the past 12 months that is clearly identified and is likely the cause of the CLBP, that can be addressed with surgery.
- Primary complaint of leg pain, or leg pain is greater than back pain
- Back pain is due to any of the following:
- Has widespread pain (e.g. fibromyalgia) or pain in other area(s), not intended to be treated in this study (e.g. neck pain, shoulder pain)
- Patient has seronegative spondyloarthropathy (e.g. rheumatoid, lupus, psoriatic)
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 |
|---|---|---|
| Spinal Cord StimulationAlso: Proclaim XR IPGUtilization of BURSTDR stimulation | Device | Spinal Cord Stimulation (SCS) |
| Conventional Medical ManagementAlso: Physical Therapy, Medications, Injections, Acupuncture, Massage Therapy, Etc.Assessing type of CMM, location and frequency. | Other | Conventional Medical Management (CMM) |
Primary outcome
The Difference in Responders Between Both Groups
Time frame: 6 Months
Improvement in pain, defined as percentage of patients who report a ≥ 50% decrease on Numeric Rating Scale (NRS).
7 secondary outcomes
Measure of Composite Responder Rate
Time frame: 6 Months
Numerical Rating Scale (NRS) Relative Change From Baseline to 6 Months
Time frame: Baseline to 6 Months
Oswestry Disability Index (ODI) Change From Baseline to 6 Months
Time frame: Baseline to 6 Months
Pain Catastrophizing Scale (PCS) Responder Rate
Time frame: 6 Months
Patient Global Impression of Change (PGIC) Responder Rate
Time frame: 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Interference Relative Change From Baseline to 6 Months
Time frame: Baseline to 6 Months
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function Relative Change From Baseline to 6 Months
Time frame: Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37642628Deer T, Gilligan C, Falowski S, Desai M, Pilitsis J, Jameson J, Moeschler S, Heros R, Tavel E, Christopher A, Patterson D, Wahezi S, Weisbein J, Antony A, Funk R, Ibrahim M, Lim C, Wilson D, Fishell M, Scarfo K, Dickerson D, Braun E, Buchanan P, Levy RM, Miller N, Duncan J, Xu J, Candido K, Kreiner S, Fahey ME, Yue J. Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Neuromodulation. 2023 Oct;26(7):1387-1399. doi: 10.1016/j.neurom.2023.07.009. Epub 2023 Aug 28.
- Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
- Individual participant dataSharing planned: No
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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.
James Yue, MD principal investigator
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation and Conventional Medical Management in people with Chronic Low-Back Pain and Refractory Pain, run by Abbott Medical Devices at 30 sites in United States.
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 30 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 18 Jun 2024). 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?
The Difference in Responders Between Both Groups (time frame: 6 Months). 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 NCT04479787, which also lists 2 linked publications.
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 3 Feb 2025.