Clinical trial NCT02595190: Treatment of the Symptomatic Sacral Perineurial Cysts
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: Sacral perineurial cysts(Tarlov Cysts)
Resting state functional magnetic resonance imaging (rfMRI)
VAS
Medicine conservative treatment
Surgical treatment
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 1. Diagnosed with symptomatic sacral perineurial cysts(e.g., lumbosacral or perineal pain, fecal or urinary functions change, sexual function change, lower limb radiation pain, muscle abate, paresthesia, etc)
* 2. Visual analog scale more than or equal to 4
* 3. Signed the informed consent
* 4. Years, range 18-60
* 5. Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores \< 50
* 6. No Congenital,Mental and other Nervous system diseases
* 7. No Serious Cardiac,Pulmonary,Hepatic and Nephritic disease
* 8. No history of drug allergy
* 9. No pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month
* 10. MRI finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group
* 11. MRI finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group

Exclusion Criteria:

* 1. Patients with lumbar common diseases(e.g., Lumbar disc, Lumbar spinal stenosis, Lumbar slippage, etc)
* 2. Researchers think that Patients with disease may be interference results(e.g., Spinal deformity, spine fracture, ankylosing spondylitis, spinal tuberculosis and spinal infection, spinal tumor, pelvic inflammatory disease and other disease of department of gynaecology, etc)
* 3. Patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc)
* 4. Patients with Magnetic resonance imaging contraindication ,including claustrophobic syndrome patients
* 5. Patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems
* 6. In the past 2 months involved in other drugs or devices clinical trials

Primary outcomes:
measure: Visual analog scale(VAS)
timeFrame: 3year
measure: Structure and Function connection change(e.g., increase or decrease the thickness of the cortex, or gray matter;function connection increase or decrease) at somatosensory area
timeFrame: 1year
Secondary outcomes:
measure: Modify Japanese orthopedic association low back pain score (M-JOA)
timeFrame: 3year
measure: Oswestry Disability Index score (DOI)
timeFrame: 3year
measure: MacNab curative effect evaluation
timeFrame: 3year
Other outcomes:
measure: Size of the cyst
timeFrame: 3year
measure: Number of the cyst
timeFrame: 3year
measure: Urine dynamics change(e.g., urinary flow rate)
timeFrame: 3year
measure: Perianal electromyography change
timeFrame: 3year
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
affiliation: Neurosurgery department of Southwest Hospital,China
name: jiangkai lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: