Cervical MyelopathyNCT04968639
The Characteristic of Axial Pain and EEG Analysis of Patients After Laminoplasty
An observational study of Cervical Myelopathy, run by Peking University Third Hospital at 2 sites in China.
Trial summary
The characteristic of axial pain and EEG analysis of patients after laminoplasty Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Myelopathy
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with CSM undergoing C3-7 open-door laminoplasty.
Who may be able to join
- Age: 18~70 years.
- Diagnosed as degenerative cervical spine myelopathy.
- Must receive C3-C7 open-door laminoplasty.
- Agree to join this study and sign the informed consent.
Who cannot join
- Severe cervical spine kyphosis.
- Cervical spine radiculopathy.
- Laminoplasty with fusion.
- Cervical spine anterior column lesion because of tumor, trauma or infection.
- Severe osteoporosis.
- Morbid obesity.
Show all 17Show fewer
- patients with mental disorder.
- Pregnancy.
- History of infection within last 3 months.
- Severe nervous system disease.
- Abnormal laboratory report of liver function, kidney function and hematologic system.
- Poor compliance.
- Patients with other surgical contraindications.
- Patients with intemperance or taking drugs.
- Patients who joined other study within the last 3 months.
- Patients with a chief complaint of neck pain (VAS score ≥3 points).
- Left handedness.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ming Yi
Beijing, Beijing Municipality, 100083
Mi Yi, Ph.D., + 86(0)10 8280 5083, mingyi@hsc.pku.edu.cn
- Recruiting
Feifei Zhou
Beijing, Beijing Municipality, 100191
Feifei Zhou, M.D., +8613581787350, orthozhou@163.com
Yu Sun, M.D.
About this study
Official title: The Characteristic of Axial Pain After Open-door Laminoplasty in Patients With Degenerative Cervical Spine Myelopathy and the Correlation With EEG Analysis: a Prospective Cohort Study.
The characteristic of axial pain and EEG analysis of patients after laminoplasty
Read the detailed description
The characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.
- Conditions
- Cervical Myelopathy
- Keywords
- Cervical Myelopathy, Axial Pain, Electroencephalogram Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Axial pain positive group | Postoperative VAS score ≥ 3 points at 3-month follow-up | |
| Axial pain negative group | Postoperative VAS score ≤ 2 points at 3-month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram analysis
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up.
Measured: 3 months after surgery.
Electroencephalogram analysis
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.
Measured: 1 year after surgery.
Visual analogue scale for axial pain
Visual analogue scale for axial pain before operation and at 3-month follow-up
Measured: 3 months after surgery.
Visual analogue scale for axial pain
Visual analogue scale for axial pain before operation and at 1-year follow-up
Measured: 1 year after surgery.
Secondary outcomes (10)
Outcome of cervical spine function
Neck Disability Index score before operation and at 3-month follow-up
Measured: 3 months after surgery.
Outcome of cervical spine function
Neck Disability Index score before operation and at 1-year follow-up
Measured: 1 year after surgery.
Quality of life outcome
SF-36 score before operation and at 3-month follow-up
Measured: 3 months after surgery.
Quality of life outcome
SF-36 score before operation and at 1-year follow-up
Measured: 1 year after surgery.
Psychological measures
Beck Depression Inventory score before operation and at 3-month follow-up
Measured: 3 month after surgery.
Psychological measures
Beck Depression Inventory score before operation and at 1-year follow-up
Measured: 1 year after surgery.
Psychological measures
Beck Anxiety Inventory score before operation and at 3-month follow-up
Measured: 3 month after surgery.
Psychological measures
Beck Anxiety Inventory score before operation and at 1-year follow-up
Measured: 1 year after surgery.
Trail Making Test
Trail Making Test before operation and at 3-month follow-up
Measured: 3 month after surgery.
Trail Making Test
Trail Making Test before operation and at 1-year follow-up
Measured: 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Jan 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968639
- Sponsor's protocol ID
- M2019197
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristic of Axial Pain After Open-door Laminoplasty in Patients With Degenerative Cervical Spine Myelopathy and the Correlation With EEG Analysis: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT04968639
- Acronym / sponsor ID
- M2019197
- Conditions
- Cervical Myelopathy
- Keywords
- Cervical Myelopathy, Axial Pain, Electroencephalogram Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jul 2021 (actual)
- 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.
The characteristic of axial pain and EEG analysis of patients after laminoplasty
Detailed description
The characteristic of axial pain after open-door laminoplasty in patients with degenerative cervical spine myelopathy and the correlation with electroencephalogram analysis: a prospective cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial pain positive group | – | –Postoperative VAS score ≥ 3 points at 3-month follow-up |
| Axial pain negative group | – | –Postoperative VAS score ≤ 2 points at 3-month follow-up |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CSM undergoing C3-7 open-door laminoplasty.
Key inclusion criteria (4 listed)
- Age: 18~70 years.
- Diagnosed as degenerative cervical spine myelopathy.
- Must receive C3-C7 open-door laminoplasty.
- Agree to join this study and sign the informed consent.
Key exclusion criteria (17 listed)
- Severe cervical spine kyphosis.
- Cervical spine radiculopathy.
- Laminoplasty with fusion.
- Cervical spine anterior column lesion because of tumor, trauma or infection.
- Severe osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Electroencephalogram analysis
Time frame: 3 months after surgery.
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 3-month follow-up.
Electroencephalogram analysis
Time frame: 1 year after surgery.
Electroencephalogram analysis (focus on the gamma oscillation at prefrontal cortex) at 1-year follow-up.
Visual analogue scale for axial pain
Time frame: 3 months after surgery.
Visual analogue scale for axial pain before operation and at 3-month follow-up
Visual analogue scale for axial pain
Time frame: 1 year after surgery.
Visual analogue scale for axial pain before operation and at 1-year follow-up
10 secondary outcomes
Outcome of cervical spine function
Time frame: 3 months after surgery.
Outcome of cervical spine function
Time frame: 1 year after surgery.
Quality of life outcome
Time frame: 3 months after surgery.
Quality of life outcome
Time frame: 1 year after surgery.
Psychological measures
Time frame: 3 month after surgery.
Psychological measures
Time frame: 1 year after surgery.
Psychological measures
Time frame: 3 month after surgery.
Psychological measures
Time frame: 1 year after surgery.
Trail Making Test
Time frame: 3 month after surgery.
Trail Making Test
Time frame: 1 year after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Cervical Myelopathy
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Stimulation-based Therapy to Improve Balance in DCM
Degenerative Cervical Myelopathy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Myelopathy, run by Peking University Third Hospital at 2 sites 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 17 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Feifei Zhou, M.D. (+8613581787350, orthozhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalogram analysis (time frame: 3 months after surgery.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.