UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046926 |
|---|---|
| Receipt number | R000053534 |
| Scientific Title | The effects of trunk muscle training with different feedback on people with low back pain: A randomized controlled trial |
| Date of disclosure of the study information | 2022/03/30 |
| Last modified on | 2025/12/23 12:10:22 |
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Basic information
Public title
The effects of trunk muscle training with different feedback on people with low back pain: A randomized controlled trial
Acronym
The effects of trunk muscle training with different feedback on people with low back pain: A randomized controlled trial
Scientific Title
The effects of trunk muscle training with different feedback on people with low back pain: A randomized controlled trial
Scientific Title:Acronym
The effects of trunk muscle training with different feedback on people with low back pain: A randomized controlled trial
Region
| Japan |
Condition
Condition
Patients with low back pain aged 20-40 years with no history of lumbar or hip surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of different feedback methods for trunk muscle training on trunk muscles and low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment using the Visual Analog Scale (VAS) at the beginning of the experiment, 4 weeks after the beginning, and 6 weeks after the beginning
Key secondary outcomes
* Assessment will be conducted at the beginning of the experiment, four weeks after the beginning, and six weeks after the beginning.
Measurement items
Evaluation of low back pain severity using the Japanese Orthopaedic Association Back Pain Evaluation Questtionare: JOABPEQ
Hip muscle strength
Trunk muscle endurance
Abdominal muscle thickness by the ultrasound imaging system
Motor control function of the lumbar spine
Spinal flexion-extension angle
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
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Control group
4 weeks of core muscle training exercises 20 minutes per day, 3 days per week
Interventions/Control_2
Weighted bands group
4 weeks of core muscle training exercises 20 minutes per day, 3 days per week with using weighted bands for feedback
Interventions/Control_3
Trunk harness group
4 weeks of core muscle training exercises 20 minutes per day, 3 days per week with using trunk harness for feedback
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unilateral or bilateral pain in the area between the 12th rib and the lower end of the lumbar region.
Key exclusion criteria
History of lumbar spine and hip surgery
Diagnosis or suspicion of a serious disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Toraiwa |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa Ku, Tokyo To
TEL
03-3819-1211
ultora3923@gmail.com
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Toraiwa |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa Ku, Tokyo To
TEL
03-3819-1211
Homepage URL
ultora3923@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Academy of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa Ku, Tokyo To
Tel
03-3819-1211
ultora3923@gmail.com
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
東京都立大学大学院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053534
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053534
Number of participants that the trial has enrolled
21
Results
An interaction effect was found for low back pain intensity, with greater improvement in the trunk harness group than in the control group. All groups showed significant improvements in JOABPEQ subscales (pain-related disability, lumbar function, and social life) and prone plank holding time. Motor control improved significantly in the trunk harness group, while abdominal muscle thickness increased in the weighted band group.
Results date posted
| 2025 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-one participants were included and divided into three groups: control (n = 7; 27.6 +- 6.6 years), weighted band (n = 7; 21.9 +- 1.8 years), and trunk harness (n = 7; 23.6 +- 3.7 years).
Participant flow
After baseline assessment, participants were randomly allocated to one of three intervention groups.
All participants received instruction in self-exercise, which was performed for a duration of four weeks.
The three groups consisted of a control group without any feedback tools, a weighted band group using a weighted band, and a trunk harness group using a trunk harness.
Post-intervention assessments were conducted after the four-week intervention period, and no participants dropped out at this time point.
Follow-up assessments were performed two weeks after completion of the intervention, and no dropouts were observed.
Adverse events
None
Outcome measures
Outcome measures included low back pain intensity assessed using the Visual Analogue Scale (VAS), the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ), the lumbar motor control test, and holding time in the prone plank test.
In addition, muscle thickness of the external oblique, internal oblique, and transversus abdominis muscles was measured using ultrasonography during resting sitting and hip flexion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053534
