A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

NCT02335229 | Terminated Results

• 1 other identifier: 20-SMI-2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain

Conditions

Chronic Post Surgical Pain

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity for Overall Pain 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).

  Baseline, 3, 6, 12 and 24-Month Visits

• Percentage of Subjects With at Least 50% Pain Reduction

  Percent of subjects with at least a 50% reduction. 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).

  3, 6, 12 and 24-Month Visits

Study Arms (1)

Axium DRG Neurostimulator

All eligible subjects recruited and treated with the Axium Neurostimulator

Device: Axium DRG Neurostimulator

Interventions

Axium DRG Neurostimulator DEVICE

Implantation with Axium DRG Neurostimulator

Axium DRG Neurostimulator

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

Patient suffering from chronic post surgical pain

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 post surgical 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 Visual Analog Scale in the primary region of pain
• Subject is able to provide written informed consent
• Pain medication dosage has been stable for at least 30 days
• Patient has been included for implantation according to standard criteria from the Dutch Neuromodulation Society

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 Dorsal Root Ganglion 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 with indwelling devices that may pose an increased risk of infection
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Jennifer Duggan
• Organization: St. Jude Medical

jduggan@sjm.com

+32(0)27746827

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 9, 2015
• Study Start: June 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Locations

NL (1)