Trial to investigate which treatment is preferred for mild symptoms due to stenosis (narrowing) in the cervical spinal canal: conservative treatment or surgery
| ISRCTN | ISRCTN16571565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16571565 |
| Secondary identifying numbers | CCMO 2021-13141 |
- Submission date
- 11/11/2021
- Registration date
- 01/02/2022
- Last edited
- 01/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Due to the ageing of the population more people will suffer from complaints and signs related to degeneration of the cervical spine (the neck region of the spine). The spinal cord may be involved, causing a loss of dexterity, walking difficulties, and even urination problems. If the clinical situation is severe, surgery will be offered to decompress the spinal cord. The goal is to maintain and hopefully improve the clinical situation. For less severe (mild) situations the best treatment is less clear. Conservative treatment and surgery are both valid options, although it may be argued that surgery will be more beneficial in the end. The aim of this study is to find out whether surgical decompression is more beneficial than conservative treatment for mild cervical spondylotic myelopathy (CSM) - a compression of the spinal cord in the neck.
Who can participate?
Adult patients with mild signs and symptoms due to compression of the spinal cord and degeneration of the spinal canal.
What does the study involve?
Participants are randomly allocated to either receive conservative treatment or undergo surgical decompression. For conservative treatment participants are referred to a physical therapist to practice hand function and improve their walking abilities. Participants are assessed at the start of the study and after 6 weeks, 3, 12 and 24 months
What are the possible benefits and risks of participating?
Since both treatments are standard in daily clinical practice, there are no additional benefits are risks for the participants.
Where is the study run from?
Radboud University Nijmegen Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
August 2021 to June 2027
Who is funding the study?
Application for grant awaiting approval
Who is the main contact?
Dr Ronald H.M.A. Bartels
Ronald.Bartels@radboudumc.nl
Contact information
Scientific
Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands
 ORCID ID |
0000-0002-8638-4660 |
|---|---|
| Phone | +31 (0)243615200 |
| ronald.bartels@radboudumc.nl |
Study information
| Study design | Multi-center randomized controlled trial with an additional economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40659_PIS.pdf |
| Scientific title | COnservative or SUrgical treatment for mild cervical spondylotic myelopathy: a multi-center randomized controlled trial |
| Study acronym | COSU |
| Study hypothesis | The primary objective of this study is to investigate whether surgical decompression is more beneficial than conservative treatment in cases of mild cervical spondylotic myelopathy (CSM). The second objective is to evaluate whether surgery is cost-effective compared with conservative treatments. |
| Ethics approval(s) | Approval pending, METC Oost Nederland (p/a Radboudumc, huispost 628, Postbus 9101, 6500 HB Nijmegen, Netherlands; +31 (0)24 361 3154; metcoost-en-cmo@radboudumc.nl) ref: Dossiernummer: 2021-13139, NL-nummer: NL78934.091.21 |
| Condition | Cervical spondylotic myelopathy |
| Intervention | For the treatment group allocation, a variable block randomization method is chosen. For this purpose, an online data system, CastorEDC (EU HQ, Amsterdam, the Netherlands), is used. Variable block sizes of four, six, and eight will be used and stratified by treatment center. Patients will be randomized in a 1:1 ratio to conservative treatment or surgical decompression. The randomisation sequence was generated by an independent statistician. Each patient will be given a unique study number. The web-based system will be supervised by the Clinical Trial Center of Radboud university medical center. Randomization will take place after the patients provide informed consent to participate. A designated member of the site team, usually a clinician or nurse involved in the participant's care, did the online randomization. Surgery: The goal of surgical intervention is the decompression of the spinal cord to halt the progression of the disease and facilitate recovery. Several approaches are possible: laminectomy with or without fusion, laminoplasty with or without fusion, anterior discectomy with fusion, corpectomy, or a circumferential approach. None of them has been proven superior. The choice of approach is dependent upon the levels of compression, the shape of the cervical spine, instability of the cervical spine, and also the preference of the surgeon; therefore, the surgical approach is at the discretion of the treating surgeon. Conservative treatment: Supervised conservative therapy will also be used. The patients are referred to a physical therapist to practice hand function and improve their walking abilities. During the study, the patients are contacted via video calls to evaluate their clinical condition. If the symptoms and signs worsen, the patients are invited to the outpatient clinic. A physical examination is performed, and surgical decompression may be offered as treatment if the neurologic condition worsens or if the patient’s conviction is altered during the course of the treatment. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Functionality of the hand is measured using the 15-s grip and release test at baseline, 6 weeks, 3, 12 and 24 months |
| Secondary outcome measures | 1. Disability is measured by the modified Japanese Orthopaedic Association (mJOA) score at baseline, 3, 12 and 24 months 2. Neck pain and disability due to neck related problems is measured by the neck disability index (NDI) at baseline, 3, 12 and 24 months 3. Quality of life is assessed by the EQ-5D-5L at baseline, 3, 12 and 24 months 4. Complications are registered in the early postoperative stage (6 weeks) 5. Healthcare resource use is measured by the iMTA Medical Consumption Questionnaire (iMCQ) at baseline, 3, 12 and 24 months 6. Productivity loss is assessed by the iMTA Productivity Cost Questionnaire (iPCQ) at baseline, 3, 12 and 24 months |
| Overall study start date | 29/08/2021 |
| Overall study end date | 01/06/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Participant inclusion criteria | 1. Adult patients 2. Signs and symptoms of cervical myelopathy 3. Radiologic signs of degenerative compressive cervical myelopathy 4. mJOA ≥15 |
| Participant exclusion criteria | 1. Non-fluent in the Dutch language 2. Soft disc as causative pathological mechanism 3. Coexisting diseases that cause signs and symptoms interfering with those of CSM, e.g., plexopathy, cerebrovascular incident, polyneuropathy due to diabetes mellitus, etc 4. Alcohol abuse (more than two units daily) 5. mJOA <15 6. Previous history of neck surgery 7. Non-degenerative CSM |
| Recruitment start date | 01/12/2022 |
| Recruitment end date | 01/06/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Nijmegen
6525GA
Netherlands
Nijmegen
6532SZ
Netherlands
Arnhem
6815 AD
Netherlands
Ubbergen
6574 NA
Netherlands
Leiden
2333 ZA
Netherlands
The Hague
2512 VA
Netherlands
Sponsor information
Hospital/treatment centre
Geert Grote Plein Zuid 10
Nijmegen
6525 GA
Netherlands
| Phone | +31 (0)243615200 |
|---|---|
| ronald.bartels@radboudumc.nl | |
| Website | https://www.radboudumc.nl/EN/Pages/default.aspx |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/11/2021 | No | Yes | ||
| Protocol file | version 2 | 12/11/2021 | 25/11/2021 | No | No |
Additional files
Editorial Notes
25/11/2021: Trial's existence confirmed by ZonMW and METC Oost Nederland.
