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A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg

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ClinicalTrials.gov Identifier: NCT02335489
Recruitment Status : Terminated (A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months)
First Posted : January 9, 2015
Results First Posted : August 2, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb

Condition or disease Intervention/treatment
Chronic Neuropathic Pain Device: Implantation with the commercially available Axium neurostimulator

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Study Start Date : March 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
Treated Subjects
All subjects recruited and treated with the Axium neurostimulator
Device: Implantation with the commercially available Axium neurostimulator



Primary Outcome Measures :
  1. Change in Pain Intensity for Overall Pain From Pre-treatment Baseline [ Time Frame: Baseline, 3, 6 and12-Months ]
    The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Neuropathic Pain of the Foot and/or Lower Leg
Criteria

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Subject is able and willing to comply with the follow-up schedule and protocol
  3. Chronic, intractable pain in the foot and/or lower leg for at least 6 months
  4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
  5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
  6. Subject is able to provide written informed consent

Exclusion Criteria:

  1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
  2. Escalating or changing pain condition within the past month as evidenced by investigator examination
  3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
  4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months
  5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
  6. Subject is unable to operate the device
  7. Subjects with indwelling devices that may pose an increased risk of infection
  8. Subjects currently has an active infection
  9. Subject has participated in another clinical investigation within 30 days
  10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  11. Subject has been diagnosed with cancer in the past 2 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335489


Locations
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Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02335489     History of Changes
Other Study ID Numbers: 14-SMI-2013
First Posted: January 9, 2015    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: February 4, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms