NCT02936245

Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established. In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Detailed description

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50 \[1\]. It is believed to have a generally progressive course over a period of years, with sudden acceleration especially following a slight head and neck injury, leading to significant disability \[2, 3\]. The treatment of CSM remains a problem, particularly in the mild and moderate forms without rapid progression. Excellent outcomes for surgery have been presented in many studies. All of the studies, however, are retrospective, and many lack a clear design, standard criteria, control groups, and sufficient follow-up, so it is difficult to compare \[4, 5, 6\]. Furthermore, several studies and critical reviews are not so optimistic. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established \[7, 8, 9\]. Twenty-five percent of patients with laminoplasty suffer from severe neck and shoulder pain for more than 3 months \[10\], with significant morbidity from the iliac crest donor site etc. Surgery to decompress and stabilize the spine is often advocated for severe or progressive symptoms, with mixed results. About two-thirds of patients improve with surgery, whereas surgery is not successful in 15% to 30% of cases \[11\]. In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Conditions

• Cervical Spondylosis With Myelopathy

Interventions

Type	Name	Description
OTHER	no specific intervention	We will not assign specific intervention in this research. We will record their baseline characteristics, received treatment, and assess the outcomes to analysis the predictors of outcome and natural history in patients with cervical spondylotic myelopathy.

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-12-01
• Completion: 2020-07-01
• First posted: 2016-10-18
• Last updated: 2016-10-18

Locations

1 site across 1 country: China