Treatment of the Symptomatic Sacral Perineurial Cysts

NCT ID: NCT02595190

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

surgery group

sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)

Group Type: EXPERIMENTAL

sacral canal cyst microscopic tamponade

Intervention Type: PROCEDURE

sacral canal cyst microscopic tamponade treatment

resting state functional magnetic resonance imaging (rfMRI)

Intervention Type: 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

drug group

gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)

Group Type: EXPERIMENTAL

gabapentin + tramadol

Intervention Type: DRUG

dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid

resting state functional magnetic resonance imaging (rfMRI)

Intervention Type: 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

control group

resting state functional magnetic resonance imaging (rfMRI)

Group Type: PLACEBO_COMPARATOR

resting state functional magnetic resonance imaging (rfMRI)

Intervention Type: 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

Interventions

sacral canal cyst microscopic tamponade

sacral canal cyst microscopic tamponade treatment

Intervention Type: PROCEDURE

gabapentin + tramadol

dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid

Intervention Type: DRUG

resting state functional magnetic resonance imaging (rfMRI)

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jiangkai Lin

Vice chief of Neurosurgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jiangkai lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgery department of Southwest Hospital,China

Locations

Southwest Hospital

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

jiangkai lin, PhD

Role: CONTACT

jklin@tmmu.edu.cn

+86-13508350708

weihua chu, PhD

Role: CONTACT

Weihua9871@163.com

+86-13657648800

Facility Contacts

jiangkai lin, PhD

Role: primary

jklin@tmmu.edu.cn

13508350708

Other Identifiers

No.29SROSWH-2015

Identifier Type: -

Identifier Source: org_study_id