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

Cervical Spondylosis With Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936245
• Other study ID #: PONH CSM
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2016
• Last updated: October 14, 2016
• Start date: October 2013
• Est. completion date: July 2020

Study information

• Verified date: October 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Cui / Xue-jun, PhD
• Phone: 18917763017
• Email: 13917715524[@]139.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylosis With Myelopathy
• Spinal Cord Diseases
• Spondylosis

Intervention

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.

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

Rowland LP. Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial. Neurology. 1992 Jan;42(1):5-13. Review. — View 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. Review. Erratum in: Am Fam Physician 2001 May 15;63(10):1916. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Japanese Orthopaedic Association scale	Japanese Orthopaedic Association scale assessed for 3 years	3 years	No
Secondary	Adverse Event	Adverse Event recorded 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years	Yes
Secondary	Visual Analogue Scale	Visual Analogue Scale assessed for 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years	No
Secondary	the Medical Outcomes Study short form health survey-36	assessed for 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years	No
Secondary	Neck Disability Index	Neck Disability Index assessed for 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years	No
Secondary	Japanese Orthopaedic Association scale	Japanese Orthopaedic Association scale assessed for 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 4 and 5 years	No

External Links

•   Cervical spondylotic myelopathy: a common cause of spinal cord dysfunction in older persons
•   Cervical spondylotic myelopathy: a review of surgical indications and decision making
•   Cervical spondylotic myelopathy: a review of surgical indications and decision making.
•   Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial