UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056307 |
|---|---|
| Receipt number | R000064179 |
| Scientific Title | Effect of using trunk harness for lumbar stabilization exercise on low back pain with control impairment |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2025/12/26 11:52:45 |
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Basic information
Public title
Effect of using trunk harness for exercise on low back pain patients
Acronym
Trunk harness trial
Scientific Title
Effect of using trunk harness for lumbar stabilization exercise on low back pain with control impairment
Scientific Title:Acronym
RCT for low back pain patients using a trunk harness
Region
| Japan |
Condition
Condition
Non specific low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of lumbar spine stabilization exercises using a trunk harness in patients with low back pain who have problems with motor control of the lumbar spine. The study will compare the differences in pain, functional disability, and muscle function between exercise therapy intervention using a trunk harness and exercise therapy intervention without a trunk harness in patients with low back pain who have problems with motor control of the lumbar spine. We believe that the results of this study will help establish effective exercise therapy for persons with low back pain, and that this research will lead to the development of preventive methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity (Visual analogue scale)
Key secondary outcomes
Japanese Orthopaedic Association Back Pain Evaluation Questionnaire
Lumbar movement control test
Prone plank test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Lumbar stabilization exercise using a trunk harness for 6 weeks
The lumbar stabilization exercise consist of intra abdominal pressure exercise, curl up, lock forwards, lock back.
Interventions/Control_2
Lumbar stabilization exercise without a trunk harness for 6 weeks
The lumbar stabilization exercise consist of intra abdominal pressure exercise, curl up, lock forwards, lock back.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients presenting with a chief complaint of low back pain with a diagnosis of nonspecific low back pain
Key exclusion criteria
Over 20 points of Central Sensitization Inventory
Over 19 points of Pain DETECT
History of hip or spinal surgery
Diagnosed or suspected of other serious illnesses
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Toraiwa |
Organization
Tokyo Metropolitan University
Division name
Human Health Sciences Department of Physical Therapy Science
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
toraiwa-taro@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Toraiwa |
Organization
Tokyo Metropolitan University
Division name
Human Health Sciences Department of Physical Therapy Science
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
ultora3923@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Taro Toraiwa
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
toraiwa-taro@ed.tmu.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
| 2024 | Year | 11 | Month | 30 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064179
