Treatment of the Symptomatic Sacral Perineurial Cysts
TSSPC
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).
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Mar 2015
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 3, 2015
November 1, 2015
5 years
October 23, 2015
November 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Modify Japanese orthopedic association low back pain score (M-JOA)
3year
Oswestry Disability Index score (DOI)
3year
MacNab curative effect evaluation
3year
Other Outcomes (4)
Size of the cyst
3year
Number of the cyst
3year
Urine dynamics change(e.g., urinary flow rate)
3year
- +1 more other outcomes
Study Arms (3)
surgery group
EXPERIMENTALsacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)
drug group
EXPERIMENTALgabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)
control group
PLACEBO COMPARATORresting state functional magnetic resonance imaging (rfMRI)
Interventions
sacral canal cyst microscopic tamponade treatment
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
Eligibility Criteria
You may qualify if:
- \. 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)
- \. Visual analog scale more than or equal to 4
- \. Signed the informed consent
- \. Years, range 18-60
- \. Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores \< 50
- \. No Congenital,Mental and other Nervous system diseases
- \. No Serious Cardiac,Pulmonary,Hepatic and Nephritic disease
- \. No history of drug allergy
- \. No pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month
- \. MRI finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group
- \. MRI finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group
You may not qualify if:
- \. Patients with lumbar common diseases(e.g., Lumbar disc, Lumbar spinal stenosis, Lumbar slippage, etc)
- \. 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)
- \. Patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc)
- \. Patients with Magnetic resonance imaging contraindication ,including claustrophobic syndrome patients
- \. Patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems
- \. In the past 2 months involved in other drugs or devices clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Hospital
Chongqing, 023, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jiangkai lin, PhD
Neurosurgery department of Southwest Hospital,China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice chief of Neurosurgery Department
Study Record Dates
First Submitted
October 23, 2015
First Posted
November 3, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
November 3, 2015
Record last verified: 2015-11