NCT02346643

Brief Summary

11-SMI-2013 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

January 7, 2015

Results QC Date

March 16, 2017

Last Update Submit

January 31, 2019

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity in Primary Region of Pain

    Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline. 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 pain) to 10 (maximum pain).

    Post treatment at 3, 6 and 12 months

  • Pain Intensity in Overall Pain

    Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline 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 pain) to 10 (maximum pain).

    Post treatment at 3, 6 and 12 months

Study Arms (1)

Treated Subjects

All subjects recruited and treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium Neurostimulator

Interventions

Implantation with the commercially available Axium NeurostimulatorDEVICE
Treated Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Pain Patients

You may qualify if:

  • 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
  • Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
  • Subject is able to provide written informed consent

You may not qualify if:

  • Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
  • 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 ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
  • Subject is unable to operate the device
  • Subjects currently has an active infection
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Location

Akademiska sjukhuest

Uppsala, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Roni Diaz
Organization
St. Jude Medical
RDiaz@sjm.com
+1 972 309 8601

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 27, 2015

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 4, 2019

Results First Posted

February 19, 2018

Record last verified: 2019-01

Locations

SE(2)