Pain
Conditions
Keywords
Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical 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.
Interventions
PROCEDUREsacral canal cyst microscopic tamponade
sacral canal cyst microscopic tamponade treatment
DRUGgabapentin + tramadol
dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid
DEVICEresting 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
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale(VAS) | 3year |
| 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 | 1year |
Secondary
| Measure | Time frame |
|---|---|
| Modify Japanese orthopedic association low back pain score (M-JOA) | 3year |
| Oswestry Disability Index score (DOI) | 3year |
| MacNab curative effect evaluation | 3year |
Other
| Measure | Time frame |
|---|---|
| Urine dynamics change(e.g., urinary flow rate) | 3year |
| Number of the cyst | 3year |
| Perianal electromyography change | 3year |
| Size of the cyst | 3year |
Countries
China
Contacts
Primary Contactjiangkai lin, PhD
Backup Contactweihua chu, PhD
Outcome results
None listed