Cervical Spondylosis With MyelopathyNCT02936245
Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylosis With Myelopathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Spondylosis With Myelopathy
- What is being tested?
- no specific intervention
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cervical spondylosis myelopathy caused by spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
Who may be able to join
- Clinical signs and symptoms of cervical cord dysfunction
- 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
- Age under 75 years
- Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging
Who cannot join
- Spinal cord compression, without clinical symptoms
- Previous surgery on the cervical spine
- Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
- Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
- Serious that require a surgical procedure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Cui / Xue-jun, PhD, 18917763017 ext. 64385700, 13917715524@139.com
Yao / Min, PhD, 13764102508 ext. 64385700, yaomin19871223@126.com
About this study
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.
Read the 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.
- Conditions
- Cervical Spondylosis With Myelopathy
- Being tested
- no specific intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no specific interventionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Japanese Orthopaedic Association scale
Japanese Orthopaedic Association scale assessed for 3 years
Measured: 3 years
Secondary outcomes (5)
Adverse Event
Adverse Event recorded 6 months, 1, 2, 3,4 and 5 years
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months, 1, 2, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylosis With MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Yongjun, PhD, Study chair, Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936245
- Sponsor's protocol ID
- PONH CSM
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: individual participant data (IPD) available
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.
PubMed 10997531Law 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.
PubMed 8209553Rowland 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.
PubMed 1734322
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy
- ClinicalTrials.gov ID
- NCT02936245
- Acronym / sponsor ID
- PONH CSM
- Conditions
- Cervical Spondylosis With Myelopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical spondylosis myelopathy caused by spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
Key inclusion criteria (4 listed)
- Clinical signs and symptoms of cervical cord dysfunction
- 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
- Age under 75 years
- Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging
Key exclusion criteria (5 listed)
- Spinal cord compression, without clinical symptoms
- Previous surgery on the cervical spine
- Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
- Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
- Serious that require a surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no specific interventionWe 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. | Other | – |
Primary outcome
Japanese Orthopaedic Association scale
Time frame: 3 years
Japanese Orthopaedic Association scale assessed for 3 years
5 secondary outcomes
Adverse Event
Time frame: 6 months, 1, 2, 3,4 and 5 years
Visual Analogue Scale
Time frame: 6 months, 1, 2, 3,4 and 5 years
the Medical Outcomes Study short form health survey-36
Time frame: 6 months, 1, 2, 3,4 and 5 years
Neck Disability Index
Time frame: 6 months, 1, 2, 3,4 and 5 years
Japanese Orthopaedic Association scale
Time frame: 6 months, 1, 2, 4 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Results publication: PubMed 10997531Young 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.
- Results publication: PubMed 8209553Law 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.
- Results publication: PubMed 1734322Rowland 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.
- Cervical spondylotic myelopathy: a common cause of spinal cord dysfunction in older personsLink provided by the sponsor.
- Cervical spondylotic myelopathy: a review of surgical indications and decision making.Link provided by the sponsor.
- Surgical treatment of cervical spondylotic myelopathy: time for a controlled trialLink provided by the sponsor.
- Cervical spondylotic myelopathy: a review of surgical indications and decision makingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Yongjun, PhD study chair
Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis With Myelopathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cui / Xue-jun, PhD (18917763017 ext. 64385700, 13917715524@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Japanese Orthopaedic Association scale (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.