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

Chronic Pain Clinical Trial

— BINGO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02346643
• Other study ID #: 11-SMI-2013
• Status: Terminated
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Intractable

Intervention

Device:
• Implantation with the commercially available Axium Neurostimulator

Locations

Country	Name	City	State
Sweden	Sahlgrenska Universitetssjukhuset	Goteborg
Sweden	Akademiska sjukhuest	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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