A Prospective Clinical Outcomes Registry

Pain Clinical Trial

— PAIN Registry  

Official title:

Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305525
• Other study ID #: C-09-01
• Status: Completed
• Start date: June 2009
• Est. completion date: April 2014

Study information

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

Clinical Trial Summary

This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites.

Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has signed and received a copy of the Informed Consent form;

2. Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads;

3. Patient is 18 years of age or older.

4. Patient is not currently participating in another clinical trial.

Exclusion Criteria:

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• St. Jude Medical Spinal Cord Stimulation Systems
Spinal cord stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcomes over time	The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices.	2 years