Tethered Cord Syndrome Clinical Trial
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.
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.
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