UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054350 |
|---|---|
| Receipt number | R000062044 |
| Scientific Title | Effects of Early Neural Mobilization on Patients After Lumbar Surgery |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2025/05/05 07:37:08 |
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Basic information
Public title
Effects of Early Neural Mobilization on Patients After Lumbar Surgery
Acronym
Effects of Early Neural Mobilization on Patients After Lumbar Surgery
Scientific Title
Effects of Early Neural Mobilization on Patients After Lumbar Surgery
Scientific Title:Acronym
Effects of Early Neural Mobilization on Patients After Lumbar Surgery
Region
| Japan |
Condition
Condition
Lumbar spinal stenosis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of neural mobilization using cervical flexion movements on the function of patients at discharge and one month after lumbar surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Oswestry Disability Index
Key secondary outcomes
Visual analog scale(Assess intesity of low back pain, leg pain, numbness)
Passive straight leg raising test
Active straight leg raising test
JOA back pain evaluation questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group:
From immediate postoperative period
Starting from the awakening from surgery, ankle plantar and dorsiflexion exercises and patella setting are performed 50 times in three sets daily to prevent deep vein thrombosis.
The postoperative day 1(Intervention is done only once on this day):
The patients get out of bed and start walking exercises by walker.
From the postoperative day 2 to discharge (interventions are done twice daily, and only once on the day of discharge):
ADL (Activities of Daily Living) training is conducted, including walking exercises, ascending and descending stairs, floor transfer, and outdoor walking training.
Stretching and strength training of the hip, knee, and ankle muscles, and core stabilization exercises, are performed according to the patient's condition.
Interventions/Control_2
Neural Mobilization Group:
In addition to the interventions performed in the control group, neural mobilization using cervical flexion movements is implemented.
The postoperative day 1:
Passive cervical flexion exercises are performed in 10 repetitions for three sets.
As a self-exercise, active cervical flexion movements are also done in 10 repetitions for three sets.
From the postoperative day 2 to discharge:
Passive cervical flexion exercises are performed in 10 repetitions for five sets.
As a self-exercise, active cervical flexion movements are also done in 10 repetitions for five sets.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent lumbar spinal surgery(laminectomy,fusion) at Funabashi Orthopaedic Hospital
Key exclusion criteria
Has a history of surgery on the cervical or thoracic spine.
Inability to move the cervical spine.
No preoperative cauda equina symptoms.
Patients with muscle weakness with a manual muscle test of less than 3 in the segment of the spinal canal stenosis.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Nihei |
Organization
Funabashi Orthopedic Hospital
Division name
Hospital Physical Therapy Department
Zip code
274-0822
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
TEL
0474255585
ynihei@fff.or.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Nihei |
Organization
Funabashi Orthopedic Hospital
Division name
Hospital Physical Therapy Department
Zip code
270-2223
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
TEL
0474255585
Homepage URL
ynihei@fff.or.jp
Sponsor or person
Institute
Funabashi Orthopedic Hospital
Institute
Department
Personal name
Nihei Yoshito
Funding Source
Organization
Funabashi Orthopedic Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Funabashi Orthopedic Hospital
Address
1-833 Hasamacho, Funabasi City, Chiba Prefecture
Tel
0474255585
ynihei@fff.or.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
船橋整形病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
36
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062044
