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Treatment of the Symptomatic Sacral Perineurial Cysts (TSSPC)

Primary Purpose

Pain

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

sacral canal cyst microscopic tamponade

gabapentin + tramadol

resting state functional magnetic resonance imaging (rfMRI)

About this trial

This is an interventional treatment trial for Pain focused on measuring Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

surgery group

drug group

control group

Arm Description

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

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

resting state functional magnetic resonance imaging (rfMRI)

Outcomes

Primary Outcome Measures

Visual analog scale(VAS)

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

Secondary Outcome Measures

Modify Japanese orthopedic association low back pain score (M-JOA)

Oswestry Disability Index score (DOI)

MacNab curative effect evaluation

Full Information

NCT ID

NCT02595190

First Posted

October 23, 2015

Last Updated

November 1, 2015

Sponsor

Southwest Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02595190

Brief Title

Treatment of the Symptomatic Sacral Perineurial Cysts

Acronym

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).

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southwest Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

Keywords

Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surgery group

Arm Type

Experimental

Arm Description

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

Arm Title

drug group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

resting state functional magnetic resonance imaging (rfMRI)

Intervention Type

Procedure

Intervention Name(s)

sacral canal cyst microscopic tamponade

Intervention Description

sacral canal cyst microscopic tamponade treatment

Intervention Type

Drug

Intervention Name(s)

gabapentin + tramadol

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

resting state functional magnetic resonance imaging (rfMRI)

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual analog scale(VAS)

Time Frame

3year

Title

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

Time Frame

1year

Secondary Outcome Measure Information:

Title

Modify Japanese orthopedic association low back pain score (M-JOA)

Time Frame

3year

Title

Oswestry Disability Index score (DOI)

Time Frame

3year

Title

MacNab curative effect evaluation

Time Frame

3year

Other Pre-specified Outcome Measures:

Title

Size of the cyst

Time Frame

3year

Title

Number of the cyst

Time Frame

3year

Title

Urine dynamics change(e.g., urinary flow rate)

Time Frame

3year

Title

Perianal electromyography change

Time Frame

3year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jiangkai lin, PhD

Phone

+86-13508350708

jklin@tmmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

weihua chu, PhD

Phone

+86-13657648800

Weihua9871@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jiangkai lin, PhD

Organizational Affiliation

Neurosurgery department of Southwest Hospital,China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Southwest Hospital

City

Chongqing

ZIP/Postal Code

023

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jiangkai lin, PhD

Phone

13508350708

jklin@tmmu.edu.cn

12. IPD Sharing Statement

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Treatment of the Symptomatic Sacral Perineurial Cysts

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