Tethered Cord SyndromeNCT03262844
Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome
A study testing Conservative treatment and Capsule surgery in people with Tethered Cord Syndrome, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Tethered Cord Syndrome
- What is being tested?
- Conservative treatment and Capsule surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2017to Apr 2020
- Phase
- Interventional
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients aged 14-20 years, without gender limitation, are willing to sign informed consent;
- patients diagnosed with tethered cord syndrome (TCS);
- patients accepted untethering surgery or resection of intra-lipomas or myelomeningocele after birth;
- patients present with the recent occurrence of bladder or bowel dysfunction, with progressive deterioration, may be accompanied by motor deficits of lower extremity;
- urodynamic examination suggests neurogenic injury;
- the current conventional treatment is difficult to achieve satisfactory clinical outcomes.
Who cannot join
- bladder or ureter obstruction;
- other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy, other brain injuries);
- anorectal malformations;
- poor health condition, unable to tolerate surgery;
- patients (or their guardians) cannot give full informed consent for cognitive dysfunction;
- patients who have participated in other clinical trials in the past 1 month.
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- patients with active hepatitis B (including HBeAg) or serological markers (HBsAg or / and HBeAg or / and HBcAb), hepatitis C, tuberculosis, cytomegalovirus infection, severe fungal infection or HIV infection;
- patients with active peptic ulcers within 3 months before randomization.
- patients with malignant neoplasms
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200001
Ximing Xu, MD, 18801784094, xi_mingxu@hotmail.com
About this study
Official title: Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome: A Conservative Treatment- Controlled, Randomized, Clinical Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Tethered Cord Syndrome
- Being tested
- Conservative treatment, Capsule surgery
- Medical subject headings
- Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentBehavioural
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.
Capsule surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Placebo comparator | Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction Receives: Behavioral: Conservative treatment |
| Capsule surgery | Experimental | Nerve root axial decompression surgery (Capsule surgery) Receives: Procedure: Capsule surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Secondary outcomes (8)
Changes of patient-reported scores assessing bowel function
Rintala Score is applied to assess bowel function and its effects on patients' quality of life.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start16 Jun 2017
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tethered Cord SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangang Shi, Shanghai Changzheng Hospital
- Investigators
- Jiangang Shi, MD, Study chair, Shanghai Changzheng Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262844
- Sponsor's protocol ID
- CZ1702TCS
- Status last verified
- Sep 2018
- First submitted
- 6 Aug 2017
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.
PubMed 26926544
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome: A Conservative Treatment- Controlled, Randomized, Clinical Study
- ClinicalTrials.gov ID
- NCT03262844
- Acronym / sponsor ID
- CZ1702TCS
- Conditions
- Tethered Cord Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 25 Aug 2017 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Placebo comparator | Behavioral: Conservative treatmentConservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction |
| Capsule surgery | Experimental | Procedure: Capsule surgeryNerve root axial decompression surgery (Capsule surgery) |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- patients aged 14-20 years, without gender limitation, are willing to sign informed consent;
- patients diagnosed with tethered cord syndrome (TCS);
- patients accepted untethering surgery or resection of intra-lipomas or myelomeningocele after birth;
- patients present with the recent occurrence of bladder or bowel dysfunction, with progressive deterioration, may be accompanied by motor deficits of lower extremity;
- urodynamic examination suggests neurogenic injury;
Key exclusion criteria (9 listed)
- bladder or ureter obstruction;
- other types of neurogenic bladder dysfunction (spinal cord injury, cerebral palsy, other brain injuries);
- anorectal malformations;
- poor health condition, unable to tolerate surgery;
- patients (or their guardians) cannot give full informed consent for cognitive dysfunction;
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 |
|---|---|---|
| Conservative treatmentThe 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. | Behavioural | Conservative treatment |
| Capsule surgeryIn 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. | Procedure or surgery | Capsule surgery |
Primary outcome
Changes of patient-reported scores assessing bladder function
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
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.
8 secondary outcomes
Changes of patient-reported scores assessing bowel function
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
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Bladder function
Time frame: At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.
Muscle power
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Improvment of clubfoot 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 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
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
Time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Background: PubMed 26926544Steinbok P, MacNeily AE, Hengel AR, Afshar K, Landgraf JM, Hader W, Pugh J. Filum Section for Urinary Incontinence in Children with Occult Tethered Cord Syndrome: A Randomized, Controlled Pilot Study. J Urol. 2016 Apr;195(4 Pt 2):1183-8. doi: 10.1016/j.juro.2015.09.082. Epub 2016 Feb 28.
- Individual participant dataSharing planned: Undecided
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Effectiveness of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction in Pediatric Tethered Cord Syndrome Post-Surgery
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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.
Jiangang Shi, MD study chair
Shanghai Changzheng Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment and Capsule surgery in people with Tethered Cord Syndrome, run by Shanghai Changzheng Hospital 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 6 inclusion and 9 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 27 Sep 2018. 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.
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 Ximing Xu, MD (+8618801784094, xi_mingxu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of patient-reported scores assessing bladder function (time frame: At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03262844, which also lists 1 linked publication.
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 27 Sep 2018.