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

a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Implantation with the commercially available Axium Neurostimulator

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesbrough, United Kingdom, Ts4 3Bw
    • James Cook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic Pain Patients

Description

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 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. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. 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 DRG 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 currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical trial 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated subjects; All subjects recruited and treated with the Axium Neurostimulator	Device: Implantation with the commercially available Axium Neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation	The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.	Post implantation at; 1, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: S ElDabe, Prof, James Cook University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 25, 2017
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimated): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 08-SMI-2012 - PREDICT