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N/A Completed N=135

A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain

Source: ClinicalTrials.gov NCT02169401 ↗
Enrolled (actual)
135
Serious AEs
3.0%
Results posted
Nov 2024
Primary outcomePrimary: Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation — 7.5; 4.4; 5.2; 4.7 cm

Summary

08-SMI-2012 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain.

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
7.5; 4.4; 5.2; 4.7; 4.9; 4.4

Eligibility Criteria

Inclusion Criteria

  • Subject is at least 18 years old
  • Subject is able and willing to comply with the follow-up schedule and protocol
  • Chronic, intractable pain for at least 6 months
  • Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
  • Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
  • In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
  • Subject is able to provide written informed consent

Exclusion Criteria

  • Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
  • Escalating or changing pain condition within the past month as evidenced by investigator examination
  • Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
  • Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
  • Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
  • Subject is unable to operate the device
  • Subjects currently has an active 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 trial 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02169401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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