Clinical trial NCT02936245: Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy
Official title: Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Spondylosis With Myelopathy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical spondylosis myelopathy caused by spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal

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.

Eligibility criteria: 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

Primary outcomes:
measure: Japanese Orthopaedic Association scale
timeFrame: 3 years
Secondary outcomes:
measure: Adverse Event
timeFrame: 6 months, 1, 2, 3,4 and 5 years
measure: Visual Analogue Scale
timeFrame: 6 months, 1, 2, 3,4 and 5 years
measure: the Medical Outcomes Study short form health survey-36
timeFrame: 6 months, 1, 2, 3,4 and 5 years
measure: Neck Disability Index
timeFrame: 6 months, 1, 2, 3,4 and 5 years
measure: Japanese Orthopaedic Association scale
timeFrame: 6 months, 1, 2, 4 and 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine
name: Wang Yongjun, PhD
role: STUDY_CHAIR
References:
citation: Young WF. Cervical spondylotic myelopathy: a common cause of spinal cord dysfunction in older persons. Am Fam Physician. 2000 Sep 1;62(5):1064-70, 1073.
citation: Law MD Jr, Bernhardt M, White AA 3rd. Cervical spondylotic myelopathy: a review of surgical indications and decision making. Yale J Biol Med. 1993 May-Jun;66(3):165-77.
citation: Rowland LP. Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial. Neurology. 1992 Jan;42(1):5-13. doi: 10.1212/wnl.42.1.5.