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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Shanghai University of Traditional Chinese Medicine

Current Primary Outcome: Japanese Orthopaedic Association scale [ Time Frame: 3 years ]

Japanese Orthopaedic Association scale assessed for 3 years


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Event [ Time Frame: 6 months, 1, 2, 3,4 and 5 years ]
    Adverse Event recorded 6 months, 1, 2, 3,4 and 5 years
  • Visual Analogue Scale [ Time Frame: 6 months, 1, 2, 3,4 and 5 years ]
    Visual Analogue Scale assessed for 6 months, 1, 2, 3,4 and 5 years
  • the Medical Outcomes Study short form health survey-36 [ Time Frame: 6 months, 1, 2, 3,4 and 5 years ]
    assessed for 6 months, 1, 2, 3,4 and 5 years
  • Neck Disability Index [ Time Frame: 6 months, 1, 2, 3,4 and 5 years ]
    Neck Disability Index assessed for 6 months, 1, 2, 3,4 and 5 years
  • Japanese Orthopaedic Association scale [ Time Frame: 6 months, 1, 2, 4 and 5 years ]
    Japanese Orthopaedic Association scale assessed for 6 months, 1, 2, 3,4 and 5 years


Original Secondary Outcome: Same as current

Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: October 12, 2016
Date Started: October 2013
Date Completion: July 2020
Last Updated: October 14, 2016
Last Verified: October 2016