Spinal Cord Stimulation (SCS) Partnership for Advancements In Neuromodulation (PAIN) Outcome Registry

Partnership for Advancements In Neuromodulation (PAIN) observational patient registry: a prospective, non-interventional, multicentre data collection of real-world patient experience in those who have received Food and Drug Administration (FDA) approved St Jude Medical (SJM) implantable device"

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000022066

Acronym

PAIN Registry

Enrollment

600

Registered

2010-01-08

Start date

2010-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To obtain “real-world” clinical outcomes of neuromodulation in patients with St. Jude Medical Neuromodulation Division devices. An observational registry is defined as non-interventional research that involves the collection of scientifically valuable information for the purpose of answering important research questions. The term 'non-interventional' means that the healthcare provider's decisions regarding the proper treatment and care of the patient are made in the course of normal clinical practice.

Interventions

Spinal Cord Stimulation System Components. The spinal cord stimulation system and related components to be used in this 2 year registry (this registry is the means in which data will be collected for this observational study and analysis) are currently available and FDA approved for use for spinal cord stimulation i.e. The devices are currently cleared for market and distribution in the United States for chronic intractable pain of the trunk and/or limbs. The registry is a database on patient o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion Criteria: Patients enrolled in this registry will comply with the following 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.

Exclusion criteria

Non compliance with inclusion criteria (protocol only details inclusions criteria as registry open to ALL patients over 18yo with a SJM Neuro device)

Outcome results