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

• Conditions: Cervical Spondylosis With Myelopathy

• Registration Number: NCT02936245
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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 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.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-18
• Primary Completion: 2019-12
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Clinical signs and symptoms of cervical cord dysfunction
2. Magnetic resonance imaging (MRI) criteria for cervical multisegmental cord compression and/or myelopathy due to spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
3. Age under 75 years
4. Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging

Exclusion Criteria

1. Spinal cord compression, without clinical symptoms
2. Previous surgery on the cervical spine
3. Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
4. Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
5. Serious that require a surgical procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Japanese Orthopaedic Association scale	3 years	Japanese Orthopaedic Association scale assessed for 3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China