NCT07358273尚未招募不适用
Conservative Care Versus Decompression Trial for Degenerative Cervical Myelopathy Pilot: A Multicenter Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
研究概览
简要总结
This study is a pilot randomized clinical trial designed to test whether it is feasible to conduct a larger study comparing two standard treatments for mild degenerative cervical myelopathy (DCM).
The main questions it aims to answer are:
- Can enough participants be recruited and successfully complete follow-up assessments?
- Will participants adhere to their assigned treatment?
Researchers will compare two groups:
- Surgical group: Participants receive decompressive spine surgery (with or without fusion).
- Conservative care group: Participants follow a structured program that includes education, fall prevention strategies, and tailored exercises.
Participants will:
- Complete baseline and follow-up assessments at 6 weeks, 6 months, and 12 months.
- In the surgical group: undergo surgery within 12 weeks of randomization and receive standard post-operative care.
- In the conservative care group: follow a 6-week progressive exercise program and continue self-management strategies.
- Complete a monthly online symptom monitoring questionnaire
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Show evidence of spinal cord compression between C2 and T1 on MRI or CT myelography conducted within 2 years of enrollment
- •Present with mild DCM defined as a score of 15-17 on the modified Japanese Orthopaedic Association (mJOA) score
排除标准
- •Clinical suspicion that myelopathic symptoms are exacerbated or caused by another neurologic condition (i.e. amyotrophic lateral sclerosis, multiple sclerosis, syringomyelia, peripheral neuropathy)
- •Demonstrate ossification of the posterior longitudinal ligament (OPLL)
- •Previous cervical spine surgery
- •Report known or suspected tandem symptomatic thoracic or lumbar spinal stenosis
- •Present with an acute traumatic spinal cord injury (i.e., central cord syndrome)
- •Have a prior history of an acute spinal cord injury
- •Have spinal cord compression due to an infectious or oncologic process
- •Inflammatory arthritis
- •Significant active health-related comorbidity (ASA Class IV or higher)
- •English language ability insufficient to complete outcome questionnaires
研究者
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