Efficacy and Safety of Nerve Root Axial Decompression Surgery in The Treatment of Tethered Cord Syndrome: A Conservative Treatment- Controlled, Randomized, Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes of patient-reported scores assessing bladder function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistical analysist do not know the group assignment.
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
研究组 & 干预措施
Conservative treatment
Conservative physiotherapy, intermittent catheterization, or drug treatment for bladder or bowel dysfunction
干预措施: Conservative treatment (Behavioral)
Capsule surgery
Nerve root axial decompression surgery (Capsule surgery)
干预措施: Capsule surgery (Procedure)
结局指标
主要结局
Changes of patient-reported scores assessing bladder function
时间窗: 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.
次要结局
- Changes of patient-reported quality of life due to bladder dysfuction(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(At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.)
- Bladder function(At 1 week pre- and 1, 12, 48, and 96 weeks post-operative follow-up visits.)
- Muscle power(At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.)
- Improvment of clubfoot deformity(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(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(At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.)
- Changes of patient-reported quality of life(At 1 week pre- and 1, 12, 24, 48, and 96 weeks post-operative follow-up visits.)
研究者
Jiangang Shi
Chief of No.2 department of spinal surgery
Shanghai Changzheng Hospital