A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

Terminated

• Conditions: Chronic Pain
• Interventions: Device: Implantation with the commercially available Axium Neurostimulator

• Registration Number: NCT02346643
• Lead Sponsor: Abbott Medical Devices

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-03-16
• Results First Submitted QC: 2017-08-10
• Results First Posted: 2018-02-19
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

Exclusion Criteria

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
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 ICD, 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 participated in another clinical investigation within 30 days
9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
10. Subject has been diagnosed with cancer in the past 2 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated Subjects	Implantation with the commercially available Axium Neurostimulator	All subjects recruited and treated with the Axium neurostimulator

Primary Outcome Measures

Name	Time	Method
Pain Intensity in Overall Pain	Post treatment at 3, 6 and 12 months	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).
Pain Intensity in Primary Region of Pain	Post treatment at 3, 6 and 12 months	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).

Trial Locations

Locations (2)

Sahlgrenska Universitetssjukhuset; 🇸🇪 Goteborg, Sweden

Akademiska sjukhuest; 🇸🇪 Uppsala, Sweden