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).

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 023
    • Recruiting
    • Southwest Hospital
    • Contact: jiangkai lin, PhD; Phone Number: 13508350708; Email: jklin@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surgery group; sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI)	Procedure: sacral canal cyst microscopic tamponade; sacral canal cyst microscopic tamponade treatment; 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
Experimental: drug group; gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI)	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; Drug: gabapentin + tramadol; dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid
Placebo Comparator: control group; resting state functional magnetic resonance imaging (rfMRI)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Other Outcome Measures

Outcome Measure	Time Frame
Size of the cyst	3year
Number of the cyst	3year
Urine dynamics change(e.g., urinary flow rate)	3year
Perianal electromyography change	3year

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: jiangkai lin, PhD, Neurosurgery department of Southwest Hospital,China

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: November 1, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: VAS; Surgical treatment; Sacral perineurial cysts(Tarlov Cysts); Resting state functional magnetic resonance imaging (rfMRI); Medicine conservative treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Cysts; Neuromuscular Diseases; Peripheral Nervous System Diseases; Tarlov Cysts; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin; Tramadol
• Other Study ID Numbers: No.29SROSWH-2015