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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery group | Experimental | sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI) |
|
| drug group | Experimental | gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI) |
|
| control group | Placebo Comparator | resting state functional magnetic resonance imaging (rfMRI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacral canal cyst microscopic tamponade | Procedure | sacral canal cyst microscopic tamponade treatment |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the cyst | 3year | |
| Number of the cyst | 3year | |
| Urine dynamics change(e.g., urinary flow rate) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiangkai lin, PhD | Contact | +86-13508350708 | jklin@tmmu.edu.cn | |
| weihua chu, PhD | Contact | +86-13657648800 | Weihua9871@163.com |
| Name | Affiliation | Role |
|---|---|---|
| jiangkai lin, PhD | Neurosurgery department of Southwest Hospital,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Recruiting | Chongqing | 023 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| gabapentin + tramadol | Drug | dose rangeļ¼gabapentin 400-1200mg tid, tramadol 100-200mg bid |
|
| resting state functional magnetic resonance imaging (rfMRI) | Device | 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 |
|
| 3year |
| 3year |
| Perianal electromyography change | 3year |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |