An observational study on the safety and efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome patients

A Multicentre Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612000350820

Acronym

HF SCS for CRPS

Enrollment

Registered

2012-03-27

Start date

2012-10-01

Completion date

2016-10-01

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

The purpose of this study is to evaluate the safety, efficacy and patient acceptance of High Frequency (HF) Spinal Cord Stimulation (SCS) for the treatment of patients with chronic neuropathic pain due to Complex Regional Pain Syndrome (CRPS). Main study endpoints will assess pain relief, functional capacity and quality of life improvements over a 12 month period.

Interventions

Evaluation of pain relief, functional capacity and quality of life improvements from baseline and their evolution over a 12 month period

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Diagnosed with CRPS according to the Budapest research diagnostic criteria Symptoms for more than 6 months and less than 5 years Failed conservative management for 3 months Average pain intensity of at least 5cm out of 10cm in the 30 days prior to the Baseline Visit (based on the baseline visit VAS) Over 18 years of age Able to provide informed consent and willing to comply with study procedures

Exclusion criteria

Contra-indication to the implantation of an SCS system Medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by a psychiatrist Female patients that are pregnant or are planning to become pregnant over the next 12 months Life expectancy of lesss than 1 year Inability to manage the technical demands of the SCS equipment

Outcome results