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Failed Back Surgery Syndrome
+4

Spinal Cord Stimulation (SCS) Therapy Study

Sponsored by MedtronicNeuro

About this trial

Last updated 10 years ago

Study ID

1673

Status

Withdrawn

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
22+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

What are the participation requirements?

Yes

Inclusion Criteria

- At least 22 years of age or older at the time of informed consent

- Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain

- Implanted with one or more Medtronic leads located in the epidural space within the thoracic area

- Receiving some level of pain relief with current SCS therapy

- On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications

- Read and understand English without assistance

- Willing and able to comply with all study procedures, study visits, and be available for the duration of the study

No

Exclusion Criteria

- Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia

- Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)

- Implanted with both a surgical and percutaneous lead

- Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation

- Has had any of the following procedures:

- Neuroablative procedure within six months
- Neurolytic block within two months
- Injection therapy for pain within four weeks
- Sympathetic block within two weeks

- Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF

- Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study

- Has an untreated psychiatric comorbidity

- Has serious drug-related behavioral issues

- Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year

- Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study

- Participating or planning to participate in another clinical trial while enrolled in this study