Spinal Modulation is a new type of stimulator.
NOT FDA approved, the stimulator will be undergoing clinical studies in the US. Eurpoe is ahead of us as it has already been approved there for some painful conditions.
Whats different about this when compared to a spinal cord stimulator?
While both devices have leads which go into the spine, the traditional spinal cord stimulator uses a lead or series of leads placed in the epidural space overlying the spinal cord- the main nerve which communcates pain up to the brain. The electrical impulses confuse the nerves in the spinal cord carrying the pain message.
The spinal modulation’s tiny lead is placed next to the DRG or dorsal root ganglion. The DRG is the main collection of sensory nuclei, the brain of sensory nerve brains so to speak. By targeting this center as opposed to the spinal cord, it is hoped that stimulation provides possible improved pain relief, perhaps a different type of band-width of pain relief with far less energy.
The jury is still out, but there is a lot of preliminary evidence that shows that the DRG may be not only a very convenient locus of stimulation, but also effective and safe.
Purpose
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).
| Condition | Intervention |
|---|---|
| Chronic Lower Limb Pain | Device: AXIUM Neurostimulator System Device: Control Spinal Cord Stimulation Device |
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)
Further study details as provided by Spinal Modulation, Inc.:
Primary Outcome Measures:
Treatment Success [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Treatment Success is defined as a reduction in pain score greater than or equal to 50 percent and the absence of a stimulation related neurological deficit.
Estimated Enrollment: 152
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: AXIUM Neurostimulator System
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.
Device: AXIUM Neurostimulator System
Other Name: DRG Stimulation
Active Comparator: Control SpinalCord Stimulation Device
The Control Spinal Cord Stimulation Device is a commercially available spinal cord stimulator indicated for the treatment of chronic lower limb pain.
Device: Control SpinalCord Stimulation Device
Other Name: SCS
Eligibility
Ages Eligible for Study: 22 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
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 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
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
Exclusion Criteria:
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
Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
Subject has previously failed spinal cord stimulation therapy
Subject currently has an active implantable device including ICD, 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01923285
Locations
United States, Arizona
HOPE Research – TPC
Phoenix, Arizona, United States, 85018
United States, California
Pain Clinic of Monterey Bay
Aptos, California, United States, 94025
Coastal Pain Research
Carlsbad, California, United States, 94025
Neurovations, Inc.
Napa, California, United States, 94558
Newport Beach Headache and Pain
Newport Beach, California, United States, 94025
Eisenhower Medical Center
Rancho Mirage, California, United States, 94025
Orthopaedic Pain Specialists
Santa Monica, California, United States, 94025
IPM Medical Group, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
Florida Pain Institute
Merritt Island, Florida, United States, 32953
Holy Cross Hospital Orthopedic Institute
Oakland Park, Florida, United States, 33334
United States, Georgia
Drug Studies of America
Marietta, Georgia, United States, 30060
United States, Mississippi
Comprehensive Pain and Rehabilitation
Pascagula, Mississippi, United States, 39581
United States, Missouri
Pain Management Associates
Independence, Missouri, United States, 64055
United States, Nevada
HOPE Research – LVSP
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Premier Pain Center
Shrewsbury, New Jersey, United States, 07702
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, South Carolina
Clinical Trials of South Carolina
Charleston, South Carolina, United States, 29406
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Houston Pain Centers
Houston, Texas, United States, 77030
United States, West Virginia
Center for Pain Relief
Charleston, West Virginia, United States, 25301
Center for Pain Relief Tri-State
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Spinal Modulation, Inc.
More Information
Additional Information:
Click here for more information about this study: ACCURATE Trial This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Spinal Modulation, Inc.
ClinicalTrials.gov Identifier: NCT01923285 History of Changes
Other Study ID Numbers: 03-SMI-2012
Study First Received: August 13, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on November 09, 2014
We will be recruiting patients for an upcomming study.
Who might benefit?
Chronic pain in the feet or legs.
Those suffering form chronic diabetic peripheral neuropathy.
Burning leg or foot pain.
Failed back surgery syndrome.
This study seeks to compare standard spinal cord stimulation techniques against a combination of standard spinal cord stimulator techniques in conjunction with peripheral nerve field stimulation techniques for the treatment of low back pain associated with failed back surgery syndrome.
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01990287
First received: November 15, 2013
Last updated: September 30, 2014
Last verified: September 2014
History of Changes
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No Study Results Posted
Disclaimer
How to Read a Study Record
Purpose
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
| Condition | Intervention |
|---|---|
| Chronic Lower Limb Pain | Device: AXIUM Neurostimulator System Device: Control Spinal Cord Stimulation Device |
Failed Back Surgery Syndrome
Post-Laminectomy Syndrome
Low Back Pain Device: SCS and PNfS
Device: SCS Alone
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain
Resource links provided by NLM:
MedlinePlus related topics: Back Pain
U.S. FDA Resources
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Evaluation of device or procedure related adverse events
Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ] Responder rate in SCS-PNfS vs SCS alone
Secondary Outcome Measures:
Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ] Functional Disability [ Time Frame: 3 months ] [ Designated as safety issue: No ] Worst pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] Rescue medication usage [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 450
Study Start Date: November 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
Experimental: SCS and PNfS
Eon or Eon Mini IPG with epidural leads in the spinal column and subcutaneous leads in the peripheral field
Device: SCS and PNfS
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
Other Name: Eon or Eon Mini IPG neurostimulation system with associated components
Active Comparator: SCS Alone
Eon or Eon Mini IPG with epidural leads in the spinal column
Device: SCS Alone
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
Other Name: Eon or Eon Mini IPG neurostimulation system with associated components
Eligibility
Ages Eligible for Study: 22 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Key Inclusion Criteria:
Subject is 22 years of age or older
Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
Subject has attempted “best” medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
Subject’s pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)
Key Exclusion Criteria:
Subject currently participating in a clinical investigation that includes an active treatment arm
Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
Subject’s overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
Subject with an infusion pump or any implantable neurostimulator device
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 an existing medical condition that is likely to require the use of diathermy in the future
Subject has peripheral vascular disease
Subject is immunocompromised
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
Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01990287
Contacts
Contact: Study Call Center 877-531-5633
Show 28 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Porter McRoberts, MD Holy Cross Orthopedic Institute
More Information
No publications provided
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01990287 History of Changes
Other Study ID Numbers: C-11-12
Study First Received: November 15, 2013
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration
Keywords provided by St. Jude Medical:
Low Back Pain
Failed Back surgery Syndrome
Post-Laminectomy Syndrome Spinal Cord Stimulation
Peripheral Nerve field Stimulation
Pain
Additional relevant MeSH terms:
Back Pain
Failed Back Surgery Syndrome
Low Back Pain
Postoperative Complications
Spinal Diseases
Syndrome
Bone Diseases Disease
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Signs and Symptoms
ClinicalTrials.gov processed this record on November 09, 2014
This study seeks to compare standard spinal cord stimulation techniques against a combination of standard spinal cord stimulator techniques in conjunction with peripheral nerve field stimulation techniques for the treatment of low back pain associated with failed back surgery syndrome.
Medtronic Sciatica MDT-15
A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects WithLumbosacral Radiculopathy
This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medtronic Spinal and Biologics
Sponsor:
Medtronic Spinal and Biologics
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01917825
First received: July 30, 2013
Last updated: June 2, 2014
Last verified: June 2014
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- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objectives of this clinical trial are to investigate the pharmacokinetics and safety of MDT-15 pellets in escalating sequential doses administered to different cohorts. Preliminary efficacy data will also be collected for assessment.
| Condition | Intervention | Phase |
| Sciatica Lumbosacral Radiculopathy |
Drug: MDT-15 | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Sequential, Dose Escalation Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy |
Resource links provided by NLM:
MedlinePlus related topics: Sciatica
Further study details as provided by Medtronic Spinal and Biologics:
Primary Outcome Measures:
- Cmax [ Time Frame: 84 days ] [ Designated as safety issue: No ]
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
- Tmax [ Time Frame: 84 days ] [ Designated as safety issue: No ]
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
- AUC0-t [ Time Frame: 84 days ] [ Designated as safety issue: No ]
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
- AUC0-∞ [ Time Frame: 84 days ] [ Designated as safety issue: No ]
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
- Incidence of Adverse Events [ Time Frame: 364 days ] [ Designated as safety issue: Yes ]
Incidence of Adverse Events as a Measure of Safety.
Secondary Outcome Measures:
- Change in Radicular Leg Pain [ Time Frame: Baseline and 364 days ] [ Designated as safety issue: No ]
Radicular leg pain measured by a 0-10 Numeric Rating Scale (NRS).
- Change in Physical Function [ Time Frame: Baseline and 364 days ] [ Designated as safety issue: No ]
Physical Functioning measured by the Modified Roland Disability Questionnaire (RMS-L).
- Change in Back Pain [ Time Frame: Baseline and 364 days ] [ Designated as safety issue: No ]
Back pain measured by a 0-10 Numeric Rating Scale (NRS).
- Change in Neuropathic Type Symptoms [ Time Frame: Baseline and 84 days ] [ Designated as safety issue: No ]
Neuropathic Type Symptoms as measured by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
- Change in Medical Outcomes study – Sleep Scale [ Time Frame: Baseline and 84 days ] [ Designated as safety issue: No ]
Sleep as measured by the Medical Outcomes Study – Sleep Scale (MOS-Sleep).
- Change in Emotional Function [ Time Frame: Baseline and 84 days ] [ Designated as safety issue: No ]
Emotional functioning as measured by the Profile of Mood States – Brief Form (POMS- Brief).
- Change in Work Function [ Time Frame: Baseline and 84 days ] [ Designated as safety issue: No ]
Work Function as measured by the Work Limitations Questionnaire (WLQ).
- Global Rating of Improvement [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Global rating of improvement as measured by a Patient Global Impression of Change (PGIC).
| Estimated Enrollment: | 54 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Experimental: MDT-15
The treatments will be administered to separate, sequential cohorts of 18 treated subjects in the following escalating doses:1 pellet, 3 pellets, and 6 pellets. |
Drug: MDT-15 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be male or female at least 18 years of age.
- Have radiating pain toward the buttock down to the leg and/or feet, unilateral.
- Have radiologic pathology change from L1 – S1 consistent with a disc protrusion, non-sequestered extrusion, or sequestered fragment, as evidenced by magnetic resonance imaging (MRI), that is consistent with the clinical signs and symptoms of lumbar radiculopathy. The MRI must have been performed within 2 months prior to screening or it will need to be repeated.
- Have primary leg pain with an average NRS score equal to or greater than 5 as measured twice a day for five days in each of two weeks during screening.
- Have failed conservative care for at least 6 weeks. The subject must have been treated non-operatively (e.g., bed rest, physical therapy, medications, TENS, and/or manipulation) for a period of at least 6 weeks.
- Be willing to stop current anti-inflammatory therapy taken for treatment of radicular pain.
- Be willing and able to keep a diary that will record study-related information.
- If sexually active female of childbearing potential, be willing to use an acceptable method of birth control during the study. Acceptable methods include oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide. Surgical sterilization by tubal ligation or hysterectomy is acceptable. Women of child bearing potential are defined as women who are <12 months since their last menstrual cycle prior to screening and have not experienced surgical menopause.
- Be able to understand the study and provide written informed consent.
Exclusion Criteria:
- Have a history of lumbar surgery, including vertebroplasty and kyphoplasty.
- Be ≤ 6 weeks after lumbar ESI or nerve block at start of screening.
- Have current radicular pain for more than 6 months.
- Have more than one epidural steroid injection at the affected level to be treated within the last 6 months.
- Have demonstrated radiographic changes consistent with subject’s symptoms at more than one level on the baseline MRI.
- Have symptomatic spinal stenosis of central origin at any level based on CT myelogram or MRI.
- Have pain that is localized in the lower back or other sites and is a greater component of the subject’s total pain than the pain in the lower leg and/or foot.
- Have physical problems that may interfere with any study assessments.
- Have known infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus.
- Have presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years (history of basal cell carcinoma will be allowed).
- Have impaired renal function (creatinine >1.5 times upper limit of normal).
- Have chronic impairment liver function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times upper limit of normal).
- Have insulin-dependent diabetes or uncontrolled diabetes mellitus (glycosylated hemoglobin [HbA1c] >7%).
- Have leukopenia (<3,500 leukocytes/uL).
- Have current orthostatic hypotension (defined as systolic blood pressure decrease of at least 20 mmHg or a diastolic blood pressure decrease of at least 10 mmHg or an increase in heart rate by 20 beats per minute within 3 minutes of standing).
- Have clinically significant risk for hypotension (e.g., hypotension defined as systolic reading <90 mmHg and/or diastolic <60 mmHg, hypovolemia, autonomic neuropathy, or other medical conditions affected by changes in blood pressure).
- Any clinically significant cardiovascular condition as evidenced by physical exam, medical history and/or baseline electrocardiogram (ECG).
- Have evidence of bradycardia as shown by heart rate of <60 beats per minute via screening ECG.
- Have any poorly-controlled or serious medical condition, psychiatric illness, or clinically significant laboratory value that, in the opinion of the investigator, could compromise the safety of the subject or the scientific integrity of the study (e.g., uncontrolled hypertension, autoimmune disease, or clinically relevant symptoms of thyroid dysfunction).
- Have cauda equina syndrome.
- Have neurological deficits, as determined by the investigator, which would interfere with the assessments required by the protocol.
- Have been previously diagnosed with peripheral neuropathy.
- Have vascular claudication, as determined by the investigator, which would interfere with the assessments required by the protocol.
- Have a history or evidence of bleeding disorder (e.g., hemophilia, disseminated intravascular coagulation disorder [DIC], or thrombocytopenia [TCP])
- Have greater than 3 mm spondylolisthesis at the affected level.
- Have BMI greater than or equal to 40, or with any anatomic issues that may interfere with placement of the MDT-15 pellets as noted by the Investigator.
- Have a diagnosis of major depression.
- Have sustained a vertebral or hip fracture within the last year.
- Have known or suspected allergy or hypersensitivity to clonidine, lidocaine, contrast media, opioids, any medication that may be given as part of the site’s standard of care related to the study drug implantation procedure, or any other medication that may be given as treatment during the study.
- Have a known or suspected allergy to polylactic acid (found in products such as Lupron Depot®, Atridox®, some types of dermal fillers, and some types of sutures).
- If female, be pregnant or breastfeeding, or desiring to become pregnant during the trial.
- Have taken an investigational drug or used an investigational device within the past 30 days or intending to use an investigational drug or device during the trial.
- Have active alcoholism or drug dependency, as determined by the investigator
- Be currently on worker’s compensation or in litigation related to injury or medical condition.
- Be in circumstances which make it difficult to maintain a usual nighttime sleep schedule (e.g., the subject works on an evening/night shift or otherwise has a work or activity schedule which could confound or interfere with study assessments).
- Have current treatment with any of the following medications:
- Systemic corticosteroids (intranasal/inhaled steroids are acceptable).
- Immunosuppressant therapy to treat autoimmune diseases (e.g., rheumatoid arthritis, multiple sclerosis, myasthenia gravis, systemic lupus erythematosus, sarcoidosis, focal segmental glomerulosclerosis, Crohn’s disease, Behcet’s Disease, pemphigus, and ulcerative colitis).
- Oral or topical products that contain clonidine (e.g., Catapres).
- Herbal supplements that contain yohimbine.
- Anti-coagulant therapy (prophylactic aspirin at 81mg/day is acceptable). If applicable, aspirin therapy should be held before and after the study procedure based on the investigator’s discretion.
- Calcium channel blocker, digoxin, or beta-adrenergic blockers.
- Have chronic use of opioids (including tramadol), defined as use 20 out of the last 30 days prior to study screening.
- Have emotional or health concerns (in the judgment of the investigator) that may compromise the safety of the subject, may make compliance difficult, or may confound the reliability of information acquired in this study.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01917825
Contacts
| Contact: Clinical Department | 1800-876-3133 ext 6068 | msbkclinicalresearch@medtronic.com |
Locations
| United States, Florida | |
| Holy Cross Orthopedic Institute | Recruiting |
| Ft Lauderdale, Florida, United States, 33334 | |
| Contact: Suzanne Whisner 954-958-4822 | |
| Principal Investigator: W Porter McRoberts, MD | |
| United States, Illinois | |
| Millennium Pain Center | Recruiting |
| Bloomington, Illinois, United States, 61701 | |
| Contact: Sara Ditchen 309-662-4321 | |
| Principal Investigator: Ramsin Benyamin, MD | |
| United States, Indiana | |
| Indiana Spine Group | Recruiting |
| Carmel, Indiana, United States, 46032 | |
| Contact: Sheetal Vinayek 317-715-5897 | |
| Principal Investigator: Kevin Macadaeg, MD | |
| Franciscan St Francis Pain and Spine Center | Recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| Contact: Katrina Yaggi 317-528-7821 | |
| Principal Investigator: Robert Prince, MD | |
| United States, Kentucky | |
| Otrimed Clinical Research | Recruiting |
| Edgewood, Kentucky, United States, 41017 | |
| Contact: Patricia Shay 859-757-1359 | |
| Principal Investigator: Pragya Gupta, MD | |
| United States, West Virginia | |
| Center for Pain Relief | Withdrawn |
| Charleston, West Virginia, United States, 25301 | |
Sponsors and Collaborators
Medtronic Spinal and Biologics
More Information
No publications provided
| Responsible Party: | Medtronic Spinal and Biologics |
| ClinicalTrials.gov Identifier: | NCT01917825 History of Changes |
| Other Study ID Numbers: | P12-06 |
| Study First Received: | July 30, 2013 |
| Last Updated: | June 2, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Medtronic Spinal and Biologics:
| radicular pain |
Additional relevant MeSH terms:
| Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases |
ClinicalTrials.gov processed this record on November 09, 2014
This is a study which seeks to evaluate an old drug used in a new way. For years and years epidurals for pain have included steroid. This approach uses a different, non-steroid drug, an old drug that has been around for a long time in a completely new and different way. A pellet form of this drug is implanted next to the inflamed nerves in the spine.
Vertiflex Totalis STEPS Trial
The STEPS – Totalis™ Trial
This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by VertiFlex, Incorporated
Sponsor:
VertiFlex, Incorporated
Information provided by (Responsible Party):
VertiFlex, Incorporated
ClinicalTrials.gov Identifier:
NCT02079038
First received: February 24, 2014
Last updated: October 6, 2014
Last verified: October 2014
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- No Study Results Posted
- Disclaimer
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Purpose
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Surgery in patients with lumbar spinal stenosis
| Condition | Intervention |
| Lumbar Spinal Stenosis | Device: Totalis Device: Sham |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Surgical Procedure in Patients With Lumbar Spinal Stenosis |
Resource links provided by NLM:
MedlinePlus related topics: Spinal Stenosis
Further study details as provided by VertiFlex, Incorporated:
Primary Outcome Measures:
- The proportion of patients who achieve the minimum clinically important difference (MCID) in any two of three domains of the Zurich Claudication Questionnaire (ZCQ) at 6 months and no interventions through 6 months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Visual Analogue Scale (VAS) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS): Compared to baseline, an improvement (in leg and/or back pain) of 20 mm (on a 100mm scale) is considered clinically significant
| Estimated Enrollment: | 168 |
| Study Start Date: | May 2014 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Active Comparator: Totalis™ Direct Decompression Procedure
Totalis |
Device: Totalis |
| Sham Comparator: Sham Surgical Procedure
Sham |
Device: Sham |
Detailed Description:
Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including ≥6 months of non-operative management.
Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness.
Eligibility
| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female subjects 55 to 85 years of age
- Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion
- VAS leg symptom severity >50 (in either leg) during episodes of neurogenic claudication
- Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms
- Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence
- Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy
Exclusion Criteria:
- Significant back, buttock or leg pain from causes other than lumbar central canal stenosis
- Axial back pain only
- Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level
- Severe lateral recess stenosis
- Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
- Prior decompressive surgery at index level (s) or fusion at any lumbar level
- Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments
- Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1
- Spondylolysis (pars fracture)
- Significant degenerative lumbar scoliosis at index level(s)
- Morbid obesity
- Significant peripheral vascular disease
- Active significant co-morbidity
- Undergoing immunosuppressive therapy or long-term steroid use
- Current spinal cord stimulator or implanted pain pump
- Life expectancy less than 2 years
- Evidence of substance abuse within the year
- Involvement or potential involvement in litigation related to the spine or worker’s compensation related to a back and/or leg issue
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02079038
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics | Recruiting |
| Birmingham, Alabama, United States, 35235 | |
| Contact: Kim Jones, RN 205-833-2228 Kim.Jones@actstudy.net | |
| Principal Investigator: Bradly Goodman, MD | |
| Sub-Investigator: Srinivas Mallempati, MD | |
| United States, Arizona | |
| Hope Research Institute | Recruiting |
| Phoenix, Arizona, United States, 85018 | |
| Contact: Megan Grier 602-288-4673 steps@hriaz.com | |
| Principal Investigator: Abram Burgher, MD | |
| Sub-Investigator: Todd Turley, MD | |
| Sub-Investigator: Matthew Doust, MD | |
| Sub-Investigator: Jonathan Carlson, MD | |
| Sub-Investigator: Steven Adler, PA-C | |
| Sub-Investigator: Randy Hamilton, NP-C | |
| Sub-Investigator: Rick Allen, PA-C | |
| Arizona Pain Specialists | Recruiting |
| Scottsdale, Arizona, United States, 85260 | |
| Contact: Ted Swing 480-245-6138 TedS@arizonapain.com | |
| Principal Investigator: Tory McJunkin, MD | |
| Sub-Investigator: Jack Anderson, MD | |
| Sub-Investigator: Paul Lynch, MD | |
| Sub-Investigator: Nicholas Scott, MD | |
| United States, California | |
| Medhat Mikhael, M.D. Inc. | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Contact: Sarah Smith 800-564-0356 pmaresearch@painassociate.com | |
| Principal Investigator: Medhat Mikhael, MD | |
| UC San Diego Healthcare Systems, Center for Pain Medicine | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Cindy Martin 858-657-7038 L6martin@ucsd.edu | |
| Principal Investigator: Farshad Ahadian, MD | |
| Orthopedic Pain Specialists | Recruiting |
| Santa Monica, California, United States, 90403 | |
| Contact: Kelly Wang 310-574-2777 ext 115 research@orthopaindocs.com | |
| Contact: Danh Le 310-574-2777 ext 115 research@orthopaindocs.com | |
| Principal Investigator: Timothy Davis, MD | |
| Sub-Investigator: Daniel Fung, MD | |
| Sub-Investigator: Diana Molinares, MD | |
| Sub-Investigator: Alexander Hershel, MD | |
| Sub-Investigator: Akash Bajaj, MD | |
| Integrated Pain Management Medical Group, Inc. | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Contact: Jonathan Briz 925-478-5490 jbriz@ipmdoctors.com | |
| Contact: Kat Abtahi 925-478-5488 research2@ipmdoctors.com | |
| Principal Investigator: Kasra Amirdelfan, MD | |
| Sub-Investigator: Navjeet Boparai, MD | |
| United States, District of Columbia | |
| GWU – Medical Faculty Associates, Inc. | Not yet recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Stacy Tam 202-741-2602 stam@mfa.gwu.edu | |
| Principal Investigator: Wayne Olan, MD | |
| United States, Florida | |
| Florida Pain Institute | Recruiting |
| Merritt Island, Florida, United States, 32953 | |
| Contact: Susan Clark, ARNP-C, CRC 321-784-8211 susanclarkflp@gmail.com | |
| Principal Investigator: Richard Gayles, MD | |
| Sub-Investigator: Ashish Udeshi, MD | |
| United States, Georgia | |
| Pain Care, LLC | Recruiting |
| Stockbridge, Georgia, United States, 30281 | |
| Contact: Melissa Campbell, NP 770-771-6580 general@georgiapaincare.com | |
| Contact: Kammie Weldon, RN 770-771-6580 general@georgiapaincare.com | |
| Principal Investigator: Vincent Galan, MD | |
| Sub-Investigator: Paul Chang, MD | |
| Sub-Investigator: David Webb, MD | |
| United States, Indiana | |
| American Health Network | Not yet recruiting |
| Muncie, Indiana, United States, 47304 | |
| Contact: Adrian R White 765-213-2876 | |
| Contact: John Luttman | |
| Principal Investigator: Neal Coleman, MD | |
| United States, Missouri | |
| Pain Management Associates | Not yet recruiting |
| Independence, Missouri, United States, 64055 | |
| Contact: Brenda Butler, RN 816-767-3257 bbutler@kcpain.com | |
| Principal Investigator: James A Scowcroft, MD | |
| Sub-Investigator: Joel Ackerman, MD | |
| United States, Oregon | |
| NeuroSpine Institute,LLC | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Contact: Shawn Potts 541-284-0530 | |
| Principal Investigator: Gregory Moore, MD | |
| Sub-Investigator: Gregory Philips, MD | |
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | Not yet recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Swati M. Shah 717-530-0003 ext 281203 sshah@hmc.psu.edu | |
| Principal Investigator: Dan Nguyen, MD | |
| Sub-Investigator: Paul Kalapos, MD | |
| Sub-Investigator: Krishnamoorthy Thamburaj, MD | |
| Performance Spine and Sports Physicians, PC | Not yet recruiting |
| Pottstown, Pennsylvania, United States, 19464 | |
| Contact: Karthik Shankar 610-970-4700 kshankar@performancespine.com | |
| Principal Investigator: Thomas Haley, DO | |
| United States, Texas | |
| Houston Pain Centers | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 832-831-6205 | |
| Principal Investigator: Allen Burton, MD | |
| Sub-Investigator: Lance Smith, MD | |
| Spine Team Texas | Recruiting |
| Southlake, Texas, United States, 76092 | |
| Contact: Clinical Research 817-442-9300 | |
| Principal Investigator: Ryan Reeves, MD | |
| Sub-Investigator: Amit T Darnule, MD | |
| United States, Virginia | |
| Virginia iSpine Physicians PC | Recruiting |
| Richmond, Virginia, United States, 23235 | |
| Contact: Clinical Research 804-330-2611 crc@vaispine.com | |
| Principal Investigator: Michael J. DePalma, MD | |
Sponsors and Collaborators
VertiFlex, Incorporated
More Information
No publications provided
| Responsible Party: | VertiFlex, Incorporated |
| ClinicalTrials.gov Identifier: | NCT02079038 History of Changes |
| Other Study ID Numbers: | 14-TDDS-01 |
| Study First Received: | February 24, 2014 |
| Last Updated: | October 6, 2014 |
| Health Authority: | United States: Centers for Medicare and Medicaid Services |
Additional relevant MeSH terms:
| Constriction, Pathologic Spinal Stenosis Bone Diseases |
Musculoskeletal Diseases Pathological Conditions, Anatomical Spinal Diseases |
ClinicalTrials.gov processed this record on November 09, 2014
This is a study of an already FDA approved device. The Totalis he Is a minimally invasive way to treat spinal stenosis surgically. A small midline incision, while the patient is awake with just local anesthesia allows access to the redundant tissue in the spine which is removed to take the pressure off of the nerves in the low back pick go to the legs.
This treats spinal stenosis and associated back and leg pain called neurogenic claudication.
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