Chronic Lower Limb PainACCURATENCT01923285
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
A study testing AXIUM Neurostimulator System in people with Chronic Lower Limb Pain, run by Abbott Medical Devices at 22 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC). Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Chronic Lower Limb Pain
- What is being tested?
- AXIUM Neurostimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 22 sitesUnited States
- Study dates
- Aug 2013to Sep 2016
- 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 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female between the ages of 22 and 75 years
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
- Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
- Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.
- Subject has failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drugs classes
Show all 9Show fewer
- Subject has had stable neurologic function in the past 30 days
- In the opinion of the Investigator, the subject is psychologically appropriate for the implantation of an active implantable medical device
- Subject is able to provide written informed consent
Who cannot join
- Back pain is the greatest region of pain as measured on the baseline VAS.
- Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
- Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
- Subject is currently involved in medically related litigation, including workers compensation
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject's pain medication(s) dosage(s) are not stable for at least 30 days
Show all 19Show fewer
- Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
- Subject has previously failed spinal cord stimulation therapy
- Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy
- Subject has pain only within a cervical distribution
- Subject has cognitive, physical or sensory impairment that, in the opinion of the Investigator, may limit their ability to operate the device
- Subject currently has an indwelling device that may pose an increased risk of infection
- Subject currently has an active systemic infection.
- Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device
- Subject has participated in another clinical investigation within 30 days
- Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the Investigator, precludes participation
- Subject has been diagnosed with cancer in the past 2 years
- Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
- Subject is a prisoner
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Pain Clinic of Monterey Bay
Aptos, California, 94025
Coastal Pain Research
Carlsbad, California, 94025
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Center for Pain Relief
Charleston, West Virginia, 25301
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Houston Pain Centers
Houston, Texas, 77030
Center for Pain Relief Tri-State
Huntington, West Virginia, 25702
Pain Management Associates
Independence, Missouri, 64055
HOPE Research - LVSP
Las Vegas, Nevada, 89106
Drug Studies of America
Marietta, Georgia, 30060
Florida Pain Institute
Merritt Island, Florida, 32953
Southeastern Spine Institute
Mt. Pleasant, South Carolina, 29464
Neurovations, Inc.
Napa, California, 94558
Newport Beach Headache and Pain
Newport Beach, California, 94025
Holy Cross Hospital Orthopedic Institute
Oakland Park, Florida, 33334
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, 39581
HOPE Research - TPC
Phoenix, Arizona, 85018
Eisenhower Medical Center
Rancho Mirage, California, 94025
Orthopaedic Pain Specialists
Santa Monica, California, 94025
Premier Pain Center
Shrewsbury, New Jersey, 07702
IPM Medical Group, Inc.
Walnut Creek, California, 94598
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)
The purpose of this study is to evaluate the safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
Read the detailed description
The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System as an aid in the management of chronic, intractable pain of the lower limbs, including unilateral or bilateral pain associated with one of the following conditions: Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).
Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.
All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.
- Conditions
- Chronic Lower Limb Pain
- Being tested
- AXIUM Neurostimulator System, Control Spinal Cord Stimulation Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXIUM Neurostimulator SystemDevice
Also called DRG Stimulation
Control Spinal Cord Stimulation DeviceDevice
Also called SCS
| Study group | Role | What they receive |
|---|---|---|
| AXIUM Neurostimulator System | Experimental | The AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area. Receives: Device: AXIUM Neurostimulator System |
| Control Spinal Cord Stimulation Device | Active comparator | The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain. Receives: Device: Control Spinal Cord Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Endpoint - Treatment Success
Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
Measured: 3 months
Secondary outcomes (1)
Positional Effects on Paresthesia Intensities
Positional effects on paresthesia intensities at 3 months in the Control group versus the Treatment Group. This endpoint will compare the difference in paresthesia scores upright and supine between the AXIUM and Control groups. Paresthesia intensity was rated by subjects using a paresthesia intensity rating scale. Subjects rated the intensity of their perception of paresthesia, while upright and supine, on an 11-point numeric rating scale from 0 representing "No feeling" to 10 "Very intense." Perceived paresthesia intensity difference between supine and upright positions was calculated and averaged across each group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016
- Study completionSep 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lower Limb 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923285
- Sponsor's protocol ID
- 03-SMI-2012
- Acronym
- ACCURATE
- Status last verified
- Nov 2020
- First submitted
- 13 Aug 2013
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.
PubMed 31494275
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center, Controlled Clinical Trial to Assess the Safety and Efficacy of the Spinal Modulation™ AXIUM™ Neurostimulator System in the Treatment of Chronic Pain (ACCURATE Trial)
- ClinicalTrials.gov ID
- NCT01923285
- Acronym / sponsor ID
- ACCURATE / 03-SMI-2012
- Conditions
- Chronic Lower Limb Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Posted 24 Nov 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 safety and effectiveness of the AXIUM Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
Detailed description
The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator System as an aid in the management of chronic, intractable pain of the lower limbs, including unilateral or bilateral pain associated with one of the following conditions: Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).
Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at least six months; and failed to achieve adequate pain relief from at least two prior pharmacologic treatments.
All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS) implant procedure. If not, subjects were exited from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXIUM Neurostimulator System | Experimental | Device: AXIUM Neurostimulator SystemThe AXIUM Neurostimulator System is an investigational spinal cord stimulation device that is designed to stimulate the dorsal root ganglion (DRG) of the spine located on the back surface of the spinal cord where nerves exit the backbone. The device has 2 parts that are placed surgically (implanted) : 1) a pulse generator which is placed under the skin in the buttocks or abdomen, and 2) up to four wires (leads) that have one end attached to the pulse generator, and the other end secured to the tissue near the target treatment area. |
| Control Spinal Cord Stimulation Device | Active comparator | Device: Control Spinal Cord Stimulation DeviceThe Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is male or female between the ages of 22 and 75 years
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject has chronic, intractable pain of the lower limb(s) for at least 6 months
- Subjects are diagnosed with complex regional pain syndrome (CRPS) and/or peripheral causalgia
- Subjects have a minimum Visual Analog Scale (VAS) greater than or equal to 60 mm in the area of greatest pain in the lower limbs.
Key exclusion criteria (19 listed)
- Back pain is the greatest region of pain as measured on the baseline VAS.
- Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
- Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by Investigator examination
- Subject is currently involved in medically related litigation, including workers compensation
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
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 |
|---|---|---|
| AXIUM Neurostimulator SystemAlso: DRG Stimulation | Device | AXIUM Neurostimulator System |
| Control Spinal Cord Stimulation DeviceAlso: SCS | Device | Control Spinal Cord Stimulation Device |
Primary outcome
Primary Composite Endpoint - Treatment Success
Time frame: 3 months
Treatment Success is defined as at least 50% lower limb pain relief (VAS score reduction) at the end of trial phase, received at least 50% lower limb pain relief at the 3-month visit post implant, and the absence of a stimulation related neurological deficit. Pain scores were measured using Visual Analog Scale (VAS). The VAS score ranges from 0-100 mm with a higher score indicating higher pain intensity ( 0 representing "No Pain" and 100 mm representing "Worst Imaginable Pain").
1 secondary outcome
Positional Effects on Paresthesia Intensities
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31494275Levy RM, Mekhail N, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Scowcroft J, Golovac S, Kapural L, Paicius R, Pope J, Samuel S, McRoberts WP, Schaufele M, Kent AR, Raza A, Deer TR. Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II. J Pain. 2020 Mar-Apr;21(3-4):399-408. doi: 10.1016/j.jpain.2019.08.005. Epub 2019 Sep 5.
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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.
Robyn Capobianco, PhD study director
Abbott
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AXIUM Neurostimulator System in people with Chronic Lower Limb Pain, run by Abbott Medical Devices at 22 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 19 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 24 Nov 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?
Primary Composite Endpoint - Treatment Success (time frame: 3 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 NCT01923285, which also lists 1 linked publication.
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 24 Nov 2020.