Treatment of the Symptomatic Sacral Perineurial Cysts

Pain Clinical Trial

— TSSPC  

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595190
• Other study ID #: No.29SROSWH-2015
• Status: Recruiting
• Phase: Phase 4
• First received: October 23, 2015
• Last updated: November 1, 2015
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: November 2015
• Source: Southwest Hospital, China
• Contact: jiangkai lin, PhD
• Phone: +86-13508350708
• Email: jklin[@]tmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Tarlov Cysts

Intervention

Procedure:
• sacral canal cyst microscopic tamponade
sacral canal cyst microscopic tamponade treatment

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

Device:
• 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

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Size of the cyst		3year	Yes
Other	Number of the cyst		3year	Yes
Other	Urine dynamics change(e.g., urinary flow rate)		3year	Yes
Other	Perianal electromyography change		3year	Yes
Primary	Visual analog scale(VAS)		3year	Yes
Primary	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	Yes
Secondary	Modify Japanese orthopedic association low back pain score (M-JOA)		3year	Yes
Secondary	Oswestry Disability Index score (DOI)		3year	Yes
Secondary	MacNab curative effect evaluation		3year	Yes