UMIN-CTR Clinical Trial

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
Email	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
Email	toru8toru22@gmail.com

Sponsor
Institute	Nagoya City West Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046445