Treatment of the Symptomatic Sacral Perineurial Cysts

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Pain

Intervention / Treatment
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* Procedure: sacral canal cyst microscopic tamponade
* Drug: gabapentin + tramadol
* Device: resting state functional magnetic resonance imaging (rfMRI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery group<br>sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI) | Procedure: sacral canal cyst microscopic tamponade<br>* sacral canal cyst microscopic tamponade treatment<br>Device: resting state functional magnetic resonance imaging (rfMRI)<br>* 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<br>|
| Experimental: drug group<br>gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI) | Drug: gabapentin + tramadol<br>* dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid<br>Device: resting state functional magnetic resonance imaging (rfMRI)<br>* 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<br>|
| Placebo Comparator: control group<br>resting state functional magnetic resonance imaging (rfMRI) | Device: resting state functional magnetic resonance imaging (rfMRI)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modify Japanese orthopedic association low back pain score (M-JOA) |  | 3year | 
| Oswestry Disability Index score (DOI) |  | 3year | 
| MacNab curative effect evaluation |  | 3year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical treatment