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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02595190
Other study ID # No.29SROSWH-2015
Secondary ID
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


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
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