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Status unknownNCT02595190TSSPCUpdated Nov 3, 2015

Treatment of the Symptomatic Sacral Perineurial Cysts

A Phase 4 interventional study of sacral canal cyst microscopic tamponade and gabapentin + tramadol in Pain, sponsored by Southwest Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.

Sponsored by Southwest Hospital, China · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • Sacral perineurial cysts(Tarlov Cysts)
  • Resting state functional magnetic resonance imaging (rfMRI)
  • VAS
  • Medicine conservative treatment
  • Surgical treatment
03

In context

Lead sponsor

Southwest Hospital, China is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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)
    1. Visual analog scale more than or equal to 4
    1. Signed the informed consent
    1. Years, range 18-60
    1. Self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores \< 50
    1. No Congenital,Mental and other Nervous system diseases
    1. No Serious Cardiac,Pulmonary,Hepatic and Nephritic disease
    1. No history of drug allergy
    1. No pain(including dysmenorrhea) or drug use (e.g., antipyretics,sleeping pills) within the last month
    1. MRI finding of sacral perineurial cysts, but without any clinical symptoms, included in the negative control group
    1. MRI finding healthy volunteers don't have sacral perineurial cysts, included in the negative control groupblank control group

Exclusion criteria

Exclusion Criteria:

    1. Patients with lumbar common diseases(e.g., Lumbar disc, Lumbar spinal stenosis, Lumbar slippage, etc)
    1. 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)
    1. Patients with other nervous system diseases(e.g., cerebral tumor, neurinoma, trigeminal neuralgia,etc)
    1. Patients with Magnetic resonance imaging contraindication ,including claustrophobic syndrome patients
    1. Patients with recent (less than 3 years) use chemical drugs or have obvious psychological problems
    1. In the past 2 months involved in other drugs or devices clinical trials
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    surgery group

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

    Procedure: sacral canal cyst microscopic tamponade · Device: resting state functional magnetic resonance imaging (rfMRI)

  • Experimental
    drug group

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

    Drug: gabapentin + tramadol · Device: resting state functional magnetic resonance imaging (rfMRI)

  • Placebo comparator
    control group

    resting state functional magnetic resonance imaging (rfMRI)

    Device: resting state functional magnetic resonance imaging (rfMRI)

Interventions

  • Proceduresacral canal cyst microscopic tamponade

    sacral canal cyst microscopic tamponade treatment

  • Druggabapentin + tramadol

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

  • Deviceresting 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

06

What researchers measure

Primary outcomes

  1. Visual analog scale(VAS)

    Time frame: 3year

  2. 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 outcomes

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

    Time frame: 3year

  2. Oswestry Disability Index score (DOI)

    Time frame: 3year

  3. MacNab curative effect evaluation

    Time frame: 3year

Other outcomes

  1. Size of the cyst

    Time frame: 3year

  2. Number of the cyst

    Time frame: 3year

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

    Time frame: 3year

  4. Perianal electromyography change

    Time frame: 3year

07

Study locations

1 of 1 sites recruiting
  • Southwest Hospital
    Chongqing, 023, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02595190
Lead sponsor
Southwest Hospital, China
Responsible party
Jiangkai Lin (Vice chief of Neurosurgery Department, Southwest Hospital, China) — Principal investigator
First posted
Nov 3, 2015
Start date
Mar 2015
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Nov 3, 2015

Study contacts

jiangkai lin, PhD
Contact
jklin@tmmu.edu.cn
+86-13508350708
weihua chu, PhD
Contact
Weihua9871@163.com
+86-13657648800
jiangkai lin, PhD
principal investigator · Neurosurgery department of Southwest Hospital,China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Tarlov Cysts

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