NCT02595190

Treatment of the Symptomatic Sacral Perineurial Cysts

A Randomized Controlled Trial to Compare the Efficacy of Medicine Conservative Treatment and Surgical Treatment for Symptomatic Sacral Perineurial Cysts (Tarlov Cysts) and the Applied Value of Resting State Functional Magnetic Resonance Imaging (rfMRI).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

There are very few data and analysis in the literature regarding the symptomatic sacral perineurial cysts. Most studies are case reports or small retrospective sample, which rarely more than 20 cases. There is no an consensus on the choice of treatment (medicine conservative treatment and surgical treatment) for symptomatic sacral perineurial cysts.Our aim, therefore, is to compare the efficacy of medicine conservative treatment and surgical treatment for symptomatic sacral perineurial cysts by a randomized controlled trial. Meanwhile, resting-state functional magnetic resonance imaging is used to detect the changes at pain related brain areas, which will be develop an objective method to evaluate the clinical curative effect of the two treatment options.

Conditions

• Pain

Interventions

Type	Name	Description
PROCEDURE	sacral canal cyst microscopic tamponade	sacral canal cyst microscopic tamponade treatment
DRUG	gabapentin + tramadol	dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid
DEVICE	resting state functional magnetic resonance imaging (rfMRI)	First time:2 days before Surgery or Drug use; Second time:3 months after Surgery or Drug use; Third time:1 year after Surgery or Drug use

Timeline

• Start date: 2015-03-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2015-11-03
• Last updated: 2015-11-03

Locations

1 site across 1 country: China