Overview
Treatment of the Symptomatic Sacral Perineurial Cysts
Status:
Unknown status
Unknown status
Trial end date:
2020-03-01
2020-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Southwest Hospital, ChinaTreatments:
Gabapentin
Tramadol
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