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Treatment of the Symptomatic Sacral Perineurial Cysts

NCT02595190 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2015-11-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Southwest Hospital, China

    lead OTHER

Principal Investigators

  • jiangkai lin, PhD · Neurosurgery department of Southwest Hospital,China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595190 on ClinicalTrials.gov