Treatment of the Symptomatic Sacral Perineurial Cysts

Phase 4

• Conditions: Pain
• Interventions: Drug: gabapentin + tramadol; Procedure: sacral canal cyst microscopic tamponade; Device: resting state functional magnetic resonance imaging (rfMRI)

• Registration Number: NCT02595190
• Lead Sponsor: Southwest Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-23
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-01
• Last Update Submitted: 2015-11-01
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery group	resting state functional magnetic resonance imaging (rfMRI)	sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)
drug group	gabapentin + tramadol	gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)
drug group	resting state functional magnetic resonance imaging (rfMRI)	gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)
control group	resting state functional magnetic resonance imaging (rfMRI)	resting state functional magnetic resonance imaging (rfMRI)
surgery group	sacral canal cyst microscopic tamponade	sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Modify Japanese orthopedic association low back pain score (M-JOA)	3year
MacNab curative effect evaluation	3year
Oswestry Disability Index score (DOI)	3year

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, China