An interventional study of Conservative treatment and Capsule surgery in Tethered Cord Syndrome, sponsored by Shanghai Changzheng Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 20 Years. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal cord, which is lacking effective treatment to relieve the symptoms and prevent progression. Dr. Shi recently proposed a new technique as nerve root axial decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should be further studied.
Purpose: The aim of this study is to compare the effectiveness and safety of clinical outcomes between capsule surgery and conservative treatment in patients with TCS. A study hypothesis is that outcomes will be improved after capsule surgery.
Methods: This study is a randomized clinical trial with a two-factor (2x7) research design. The TCS patients will be randomly assigned in one of the two treatment groups: capsule surgery and conservative treatment. Seven outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits, including: International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF), Rintala Score, a new developed Chinese version of questionnaire, Oswestry disability index (ODI), SF-12, foot function index (FFI) and Pirani score. Urodynamic testing, bladder ultrasonography, electromyogram, muscle strength and sensation of lower limbs will be obtained before and post treatment, to determine the patient's function of lower limbs. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the conservative group will be followed up in the outpatient clinic. The capsule surgery group will receive the nerve root axial decompression surgery (capsule surgery).
Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences in the seven measures between groups and at the five different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the urodynamics and muscle strength data over time and between groups.
Background: Tethered cord syndrome (TCS) is a progressive clinical condition including a series of neurological dysfunctions and deformities attributable to abnormally increased tension on the spinal cord. The standard surgical treatment is untethering the spinal cord and correction of the related deformity. Although reported results are encouraging, it continues to pose challenges on management of TCS patients. Symptomatic re-tethering seems to be an inevitable result, which occurs in 20%-50% patients after untethering. Recently, filum dissection was found no good to improve urinary symptoms compared to conservative treatment in teenagers as reported in an RCT study. Also, it remained controversy when to perform the surgery and how to evaluate the benefits of surgery or conservative treatment. Dr. Shi recently proposed a new technique as nerve root axial decompression surgery, which is also called capsule surgery, to treat patients with TCS. Yet, the effectiveness and safety should be further studied.
Purpose: The aim of this study is to compare the effectiveness and safety of clinical outcomes between capsule surgery and conservative treatment in patients with TCS. A study hypothesis is that outcomes will be improved after capsule surgery.
Methods: This study is a randomized clinical trial with a two-factor (2x7) research design. The TCS patients will be randomly assigned in one of the two treatment groups: capsule surgery and conservative treatment. Seven outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, and 96 weeks post-operative follow-up visits, including: (1) International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) to assess the urinary functions, (2) Rintala Score for bowel function, (3) a new developed Chinese version of questionnaire to assess the quality of life in patients and parents due to bladder dysfunction. (4) Oswestry disability index (ODI) to assess the function of back and lower limbs, (5)SF-12 for whole quality of life, (6) Pirani score to assess clubfoot deformity, and (7) foot function index to assess the impacts on quality of life due to clubfoot. Urodynamics, bladder ultrasonography, muscle strength and sensation of lower limbs will be obtained before and post treatment, to determine the patient's function of lower limbs. The investigator performing the outcome measures will be blinded to group assignment, and therefore will not participate in treatment. After randomization, the conservative group will be followed up in the outpatient clinic. The capsule surgery group will receive the nerve root axial decompression surgery.
Data Analysis: Two 2x7 MANOVAs with repeated measures will be used to examine the differences in the four measures between groups and at the five different time frames with the α level set at 0.05. Non-parametric tests (Mann-Whitney U tests) will be used to compare the differences in the urodynamics and muscle strength data over time and between groups.
47 studies on the registry are indexed under Neural Tube Defects; 9 are open to participants now.
This study's planned enrollment of 36 is below the median of 47 across 26 interventional studies indexed under Neural Tube Defects.
Browse Neural Tube Defects studies →Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction
Behavioral: Conservative treatment
Nerve root axial decompression surgery (Capsule surgery)
Procedure: Capsule surgery
The conservative treatment group will be given diet and nursing guidance, then the drug treatment or physiotherapy will be given according to the conditions of patients. Patients with bladder dysfunction will be guided to perform routine intermittent catheterization with help of their parents.
In the multiple segments of the spine, articular facet joint and intervertebral disc will be resected to achieve the effect of decompression. Specific surgical segments, osteotomy range, decompression degree of each patient needs to be designed individually.
Changes of patient-reported scores assessing bladder function
International Consultation on Incontinence Modular Questionnaire Short Version (ICI-Q-SF) is used to assess urinary function and the impacts on patient's quality of life due to urinary problems.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing bowel function
Rintala Score is applied to assess bowel function and its effects on patients' quality of life.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Changes of patient-reported quality of life due to bladder dysfuction
A new developed Chinese version of questionnaire is used to assess the quality of life in patients and parents due to bladder dysfunction.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Bladder function
Urodynamic testing is performed to determine the bladder function, including bladder pressure, bladder capacity, residual volume, and compliance of bladder.
Time frame: At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.
Muscle power
Muscle power is tested by manual assessment, which is classified into 6 levels.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Improvment of clubfoot deformity
Pirani questionnaire is applied to assess the severity of clubfoot deformity by the examiner.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing foot deformity
Foot function index is applied to assess the impacts on patients' quality of life due to foot deformity
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Changes of patient-reported scores assessing function of back and lower limbs
Oswestry disability index (ODI) is applied to assess the function of back and lower limbs.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Changes of patient-reported quality of life
SF-12 is applied to assess the impacts on quality of life due to tethered cord syndrome.
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Plan to share: Undecided
Started Jun 2017 (actual). Primary completion is estimated for Apr 2019, 22 months after the start.
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This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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