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

NCT ID: NCT02936245

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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

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Cervical Spondylosis With Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang Yongjun, PhD

Role: STUDY_CHAIR

Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine

Locations

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Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cui / Xue-jun, PhD

Role: CONTACT

18917763017 ext. 64385700

Yao / Min, PhD

Role: CONTACT

13764102508

Facility Contacts

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Cui / Xue-jun, PhD

Role: primary

18917763017 ext. 64385700

Yao / Min, PhD

Role: backup

13764102508 ext. 64385700

References

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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.

Reference Type RESULT
PMID: 10997531 (View on PubMed)

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.

Reference Type RESULT
PMID: 8209553 (View on PubMed)

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.

Reference Type RESULT
PMID: 1734322 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/10997531

Cervical spondylotic myelopathy: a common cause of spinal cord dysfunction in older persons

https://www.ncbi.nlm.nih.gov/pubmed/1734322

Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial

Other Identifiers

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PONH CSM

Identifier Type: -

Identifier Source: org_study_id

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