Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 8:50 PM
Study NCT ID:
NCT04039633
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Sponsor:
St. Olavs Hospital
Organization:
Study Overview
Official Title:
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.
The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: