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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Spondylosis With Myelopathy
• Intervention / Treatment: Other: no specific intervention

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 Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Cui / Xue-jun, PhD; Phone Number: 64385700 18917763017; Email: 13917715524@139.com
• Study Contact Backup: Name: Yao / Min, PhD; Phone Number: 13764102508; Email: yaomin19871223@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital, Shanghai University of Traditional Chinese Medicine
      • Contact: Cui / Xue-jun, PhD; Phone Number: 64385700 18917763017; Email: 13917715524@139.com
      • Contact: Yao / Min, PhD; Phone Number: 64385700 13764102508; Email: yaomin19871223@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Japanese Orthopaedic Association scale	Japanese Orthopaedic Association scale assessed for 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Adverse Event recorded 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Investigators: Study Chair: Wang Yongjun, PhD, Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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. Erratum In: Am Fam Physician 2001 May 15;63(10):1916.
• 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.
• 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.

Helpful 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.
• Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial
• Cervical spondylotic myelopathy: a review of surgical indications and decision making

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Cord Diseases; Bone Marrow Diseases; Spondylosis
• Other Study ID Numbers: PONH CSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: individual participant data (IPD) available