PainPhase 4TSSPCNCT02595190
Treatment of the Symptomatic Sacral Perineurial Cysts
A Phase 4 study testing sacral canal cyst microscopic tamponade, gabapentin + tramadol and resting state functional magnetic resonance imaging (rfMRI) in people with Pain, run by Southwest Hospital, China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- sacral canal cyst microscopic tamponade, gabapentin + tramadol and resting state functional magnetic resonance imaging (rfMRI)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital
Chongqing, 023
jiangkai lin, PhD, 13508350708, jklin@tmmu.edu.cn
About this study
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).
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.
- Conditions
- Pain
- Being tested
- sacral canal cyst microscopic tamponade, gabapentin + tramadol, resting state functional magnetic resonance imaging (rfMRI)
- Keywords
- Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical treatment
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral canal cyst microscopic tamponadeProcedure or surgery
sacral canal cyst microscopic tamponade treatment
gabapentin + tramadolDrug
dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid
resting state functional magnetic resonance imaging (rfMRI)Device
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
| Study group | Role | What they receive |
|---|---|---|
| surgery group | Experimental | sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI) Receives: Procedure: sacral canal cyst microscopic tamponade; Device: resting state functional magnetic resonance imaging (rfMRI) |
| drug group | Experimental | gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI) Receives: Drug: gabapentin + tramadol; Device: resting state functional magnetic resonance imaging (rfMRI) |
| control group | Placebo comparator | resting state functional magnetic resonance imaging (rfMRI) Receives: Device: resting state functional magnetic resonance imaging (rfMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale(VAS)
Measured: 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
Measured: 1year
Secondary outcomes (3)
Modify Japanese orthopedic association low back pain score (M-JOA)
Measured: 3year
Oswestry Disability Index score (DOI)
Measured: 3year
MacNab curative effect evaluation
Measured: 3year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangkai Lin, Southwest Hospital, China
- Investigators
- jiangkai lin, PhD, Principal investigator, Neurosurgery department of Southwest Hospital,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595190
- Sponsor's protocol ID
- No.29SROSWH-2015
- Acronym
- TSSPC
- Status last verified
- Nov 2015
- First submitted
- 23 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT02595190
- Acronym / sponsor ID
- TSSPC / No.29SROSWH-2015
- Conditions
- Pain
- Keywords
- Sacral perineurial cysts(Tarlov Cysts), Resting state functional magnetic resonance imaging (rfMRI), VAS, Medicine conservative treatment, Surgical treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgery group | Experimental | Procedure: sacral canal cyst microscopic tamponade, Device: resting state functional magnetic resonance imaging (rfMRI)sacral canal cyst microscopic tamponade treatment; resting state functional magnetic resonance imaging (rfMRI) |
| drug group | Experimental | Drug: gabapentin + tramadol, Device: resting state functional magnetic resonance imaging (rfMRI)gabapentin + tramadol tablets; resting state functional magnetic resonance imaging (rfMRI) |
| control group | Placebo comparator | Device: resting state functional magnetic resonance imaging (rfMRI)resting state functional magnetic resonance imaging (rfMRI) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacral canal cyst microscopic tamponadesacral canal cyst microscopic tamponade treatment | Procedure or surgery | surgery group |
| gabapentin + tramadoldose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid | Drug | drug group |
| 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 | Device | control group, drug group, surgery group |
Primary outcome
Visual analog scale(VAS)
Time frame: 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
Time frame: 1year
3 secondary outcomes
Modify Japanese orthopedic association low back pain score (M-JOA)
Time frame: 3year
Oswestry Disability Index score (DOI)
Time frame: 3year
MacNab curative effect evaluation
Time frame: 3year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jiangkai lin, PhD principal investigator
Neurosurgery department of Southwest Hospital,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sacral canal cyst microscopic tamponade, gabapentin + tramadol and resting state functional magnetic resonance imaging (rfMRI) in people with Pain, run by Southwest Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiangkai lin, PhD (+86-13508350708, jklin@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale(VAS) (time frame: 3year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.