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

NCT02169401 | Completed Results

• 1 other identifier: 08-SMI-2012 - PREDICT
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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

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 Neurostimulator DEVICE

Treated subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robyn Capobianco
• Organization: Abbott

robyn.capobianco@abbott.com

512-286-4274

Study Officials

• S ElDabe, Prof

  James Cook University Hospital

  PRINCIPAL INVESTIGATOR

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: June 13, 2014
• First Posted: June 23, 2014
• Study Start: November 1, 2012
• Primary Completion: January 25, 2017
• Study Completion: January 25, 2017
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-09

Locations

GB (1)