UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053766 |
|---|---|
| Receipt number | R000061349 |
| Scientific Title | The effect of dynamic stretching on the hip range of motion and low back pain |
| Date of disclosure of the study information | 2024/03/03 |
| Last modified on | 2024/03/03 23:35:55 |
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Basic information
Public title
Investigation of the benefit of compass stretching for the hip range of motion and low back pain
Acronym
The effect of compass stretching
Scientific Title
The effect of dynamic stretching on the hip range of motion and low back pain
Scientific Title:Acronym
The effect of dynamic stretching on the hip range of motion and low back pain
Region
| Japan |
Condition
Condition
limitation of hip range of motion, low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of the dynamic stretching named compass stretching on the hip range of motion and low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hip range of motions, visual analog scale (VAS), and Oswestry disability index (ODI) score before the first stretching and at the end of week 4
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The stretching technique involved actively abducting a hip maximally from 0 degrees of abduction with the knee extended and maintaining the position for 5 seconds in the supine position. Each stretching set consists of three repetitions of stretching both legs. The participants performed the set at night once daily for four weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult group:
Healthy adults without any problems in the lumbar spine and lower extremities.
Low back pain group:
Adult without any problems in the lower extremitiesvwho had LBP for at least three months.
Key exclusion criteria
1. The participant requests withdrawal during the observation period.
2. The participant is difficult to follow up during the observation period.
3. Any illness or injury that may affect the study result occurs in the participant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Sano |
Organization
Owase General Hospital
Division name
Department of orthopediac surgery
Zip code
519-3653
Address
5-25 Uenocho, Owase, Mie, Japan
TEL
3172080154
tomohiko19810122@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Sano |
Organization
Owase General Hospital
Division name
Department of orthopediac surgery
Zip code
5193653
Address
5-25 Uenocho, Owase, Mie, Japan
TEL
0597223111
Homepage URL
owase-hp@city.lg.jp
Sponsor or person
Institute
Tomohiko Sano, department of orthopedic surgery, Owase General Hospital
Institute
Department
Personal name
Funding Source
Organization
No fundings
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
Ethics Comittee of Owase General Hospital
Address
5-25 Uenocho, Owase, Mie, Japan
Tel
0597223111
owase-hp@city.lg.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
| 2024 | Year | 03 | Month | 03 | 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
43
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061349
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
