Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs (Prodigy-I)

Abbott

Status: Completed

Conditions: Chronic Pain

Treatments: Procedure: Burst and Tonic stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143791

NM-13-038-ID-SC

Details and patient eligibility

About

The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
• Patient diagnosed with radiculopathy
• Patient diagnosed with neuropathic pain
• Patient is considered by the investigator as a candidate for implantation of a SCS system
• Patient is ≥ 18 years of age
• Patient must be willing and able to comply with study requirements
• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion criteria

• Patient is diagnosed with ischemic pain
• Patient is diagnosed with arachnoiditis
• Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
• Patient is diagnosed with peripheral vascular disease (PVD)
• Patient is diagnosed with diabetic neuropathic pain
• Patient is diagnosed with chronic migraine
• Patient is immune-compromised
• Patient has history of cancer requiring active treatment in the last 6 months
• Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
• Patients with a SCS system or implantable infusion pump implanted previously
• Patient has a life expectancy of less than one year
• Patient is pregnant or is planning to become pregnant during the duration of the investigation
• Patient is unable to comply with the follow up schedule
• Patient needing legally authorized representative
• Patient unable to read and write
• Patient is currently participating in another clinical investigation with an active treatment arm.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

Burst and Tonic stimulation

Experimental group

Description:

All subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion.

Treatment:

Procedure: Burst and Tonic stimulation