UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059670 |
|---|---|
| Receipt number | R000068254 |
| Scientific Title | Effects of a Behavior Change Techniques-Based Exercise Intervention Among Heavy Manual Workers with Low Back Pain: An Exploratory Study |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/11/06 19:13:17 |
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Basic information
Public title
Exercise intervention using behavior change techniques for low back pain in heavy manual workers: an exploratory study
Acronym
Exercise intervention using behavior change techniques for low back pain in heavy manual workers: an exploratory study
Scientific Title
Effects of a Behavior Change Techniques-Based Exercise Intervention Among Heavy Manual Workers with Low Back Pain: An Exploratory Study
Scientific Title:Acronym
Effects of a Behavior Change Techniques-Based Exercise Intervention Among Heavy Manual Workers with Low Back Pain: An Exploratory Study
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the extent to which exercise interventions utilizing behavioral change techniques contribute to improvements in low back pain and related functional outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity (Visual Analog Scale) will be assessed using a questionnaire before and after the 12-week intervention period.
Key secondary outcomes
Before and after the 12-week intervention period, the following will be assessed using questionnaires:
- Degree of ADL impairment (Roland-Morris Disability Scale)
- Presenteeism (The Quantity and Quality method)
- Pain catastrophizing (Pain Catastrophizing Scale)
- Kinesiophobia (Tampa Scale for Kinesiophobia)
- Self-efficacy
- Stages of change
Physical activity levels will be assessed using an activity monitor.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The initial intervention will be conducted within two weeks of registration. The intervention will last 12 weeks and will be delivered in a group format by a certified physical therapist in person. The intervention will utilize behavioral change techniques to support the practice of exercises (gymnastics) aimed at improving low back pain. As part of the behavioral change techniques, participants will be supported in setting specific, measurable behavioral goals. A monitoring sheet will be distributed for self-monitoring the frequency of back pain exercise practice, enabling monitoring and feedback. Additionally, group sessions will be held to convey accurate knowledge about back pain, exercise methods, and their effects, aiming to build knowledge.
Interventions/Control_2
Distribution of leaflets detailing exercises for low back pain
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals experiencing lower back pain for over one month.
2. Individuals aged 20 to 60 years old.
3. Individuals engaged in heavy labor such as manufacturing, whose primary work duties do not involve desk work.
4. Individuals not currently receiving rehabilitation programs or hospital treatment for back pain at the time of registration.
5. Individuals who fully understand the study content and can provide written consent.
Key exclusion criteria
1. Individuals with a confirmed history of spinal disorders such as herniated discs, spinal stenosis, spinal compression fractures, spinal tumors, or infectious spondylitis.
2. Individuals currently restricted by a physician from exercise or physical activity due to low back pain or other health reasons.
3. Pregnant individuals or those who have undergone lumbar surgery within the past year.
4. Individuals with serious complications such as heart disease, respiratory disease, kidney disease, or liver disease, where participation in the study is deemed to potentially compromise safety.
5. Individuals with severe mental disorders (e.g., schizophrenia, major depressive disorder) that may make cooperation with or understanding of the study difficult.
6. Individuals who have difficulty communicating in Japanese.
7. Individuals deemed unsuitable for participation in this study by the research staff for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takehiko |
| Middle name | |
| Last name | Tsujimoto |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060, Nishikawatsu-cho, Matsue, Shimane, Japan
TEL
+81-852-32-9060
tsujimoto@hmn.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takehiko |
| Middle name | |
| Last name | Tsujimoto |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060, Nishikawatsu-cho, Matsue, Shimane, Japan
TEL
+81-852-32-9060
Homepage URL
tsujimoto@hmn.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Shimane University
Address
1060, Nishikawatsu-cho, Matsue, Shimane, Japan
Tel
+81-852-32-9060
tsujimoto@hmn.shimane-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
| 2025 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068254
