21-SMI-2014 A Post Market Observational Study on the Effect of Dorsal Root Ganglion (DRG) Stimulation in Patients with Chronic Low Back Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome)

A Post Market Observational Study on the Effect of DRG Stimulation in Patients with Chronic Low Back Pain Following Surgical Lumbar Discectomy (Failed Back Surgery Syndrome): SYMPATHY Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000584639

Acronym

SYMPATHY

Enrollment

Registered

2014-05-30

Start date

2014-06-30

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

An observational, questionnaire based study in which the effectiveness of DRG stimulation as a treatment for chronic low back pain will be assessed in patients routinely scheduled for this treatment

Interventions

Observational study on the effectiveness of DRG Stimulation. DRG stimulation is a type of Spinal Cord Stimulation (SCS) which targets specific neural structures with electrical therapy by implanting a stimulating electrode in the epidural space. Suitable subjects will first have a trial of the therapy to determine effect and if successful will have the full system implanted. Implanted subjects will be followed prospectively for 1 year with follow up observations at 1 week, 1 month, 3 month, 6 mo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Chronic Low Back Pain following surgical lumbar discectomy

Exclusion criteria

Surgical spinal procedures other than a lumbar discectomy Significant bi-lateral leg pain greater in intensity than their low back pain

Outcome results