UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040692 |
|---|---|
| Receipt number | R000046445 |
| Scientific Title | A randomized controlled trial for the intervention effect of early exercise therapy on axial pain after cervical laminoplasty |
| Date of disclosure of the study information | 2020/06/09 |
| Last modified on | 2021/11/24 19:19:35 |
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Basic information
Public title
A study on the effect of exercise therapy on the cervical spine after cervical laminoplasty on the reduction of axial pain
Acronym
A study on the effect of exercise therapy on the cervical spine after cervical laminoplasty on the reduction of axial pain
Scientific Title
A randomized controlled trial for the intervention effect of early exercise therapy on axial pain after cervical laminoplasty
Scientific Title:Acronym
A randomized controlled trial for the intervention effect of early exercise therapy on axial pain after cervical laminoplasty
Region
| Japan |
Condition
Condition
Cervical Spondylotic Myelopathy
Ossification of the Posterior Longitudinal Ligament
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the range of motion training and cervical extension muscle strengthening of the cervical spine from early post-operative cervical laminoplasty can reduce axial pain at 3 months post-operatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
axial pain:visual analogue scale(VAS)
Japanese Orthopaedic Association Cervical Myelopathy Evaluation
Questionnaire(JOACMEQ):If you feel pain or stiffness in your neck or shoulders, mark the degree
evaluation period:Pre-op, 2weeks post-op, 3months post-op
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cervical exercises group
Post-op day 2.
Initiate cervical extensor muscle strengthening and cervical range of motion exercises, education, gait exercises, cervical muscle manual stretching, and postural instruction.
Cervical spine extensor muscle strengthening: 3 sets of 10 isometric muscle strengthening exercises of 5 seconds
Cervical spine range of motion exercises: painless range of motion extension and rotation
Standard intervention frequency: 20 to 40 minutes/day
Post-op day 14.
Discharged after using the pamphlets to teach self-training in cervical extension muscle strengthening and cervical range of motion exercises.
Self-trainingCervical spine extensor muscle strengthening: 3 sets of 10 isometric muscle strengthening for 5 seconds (3 times/day)
Cervical spine range of motion: 5 reps in each direction as long as there is no pain (3 times/day)
Interventions/Control_2
Stretching group
Post-op day 2.
Begin cervical muscular manual stretching, postural instruction, education, and gait practice.
Post-op day 14.
Use the pamphlet to teach good posture
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The criteria for selection are patients between the ages of 40 and 89 who were diagnosed with cervical spondylotic myelopathy or cervical ossification of the posterior longitudinal ligament at Nagoya City Medical Center and who are scheduled for C3-C6 laminoplasty.
Key exclusion criteria
Excludes patients with a history of cervical spine surgery and cerebrovascular accidents, and patients who plan to continue to use the cervical spine collar after surgery.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Uehara |
Organization
Nagoya City West Medical Center
Division name
Physical Medicine and Rehabilitation
Zip code
4628508
Address
1-1-1 Hirate-cho,Kita-ku,Nagoya,Aichi
TEL
0529918121
toru8toru22@gmail.com
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Uehara |
Organization
Nagoya City West Medical Center
Division name
Physical Medicine and Rehabilitation
Zip code
4628508
Address
1-1-1 Hirate-cho,Kita-ku,Nagoya,Aichi
TEL
0529918121
Homepage URL
toru8toru22@gmail.com
Sponsor or person
Institute
Nagoya City West Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics of Hirosaki University Graduate School of Health Sciences
Address
66-1, Hon-cho, Hirosaki-shi, Aomori, 036-8564
Tel
0172395905
jm5905@hirosaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
124
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046445
