UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060467 |
|---|---|
| Receipt number | R000069112 |
| Scientific Title | A Single-Blind Parallel-Group Randomized Controlled Trial on the Effects of Spinal Mobility and Stability Improvement Exercises on Trunk Function and Low Back Pain in Patients with Nonspecific Chronic Low Back Pain |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/26 11:38:18 |
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Basic information
Public title
Effect of Spinal Mobility and Stability Improvement Exercises on Reducing Low Back Pain in Individuals with Chronic Low Back Pain
Acronym
Effect of Spinal Mobility and Stability Improvement Exercises on Reducing Low Back Pain in Individuals with Chronic Low Back Pain
Scientific Title
A Single-Blind Parallel-Group Randomized Controlled Trial on the Effects of Spinal Mobility and Stability Improvement Exercises on Trunk Function and Low Back Pain in Patients with Nonspecific Chronic Low Back Pain
Scientific Title:Acronym
SMS-CLBP trial
Region
| Japan |
Condition
Condition
Nonspecific chronic low back pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic nonspecific low back pain refers to low back pain lasting more than three months with no identifiable direct cause, and it tends to become refractory. Exercise therapy is considered adequate for chronic nonspecific low back pain, but the efficacy of specific exercises has not been demonstrated. Intervention methods vary and are left to the discretion of individual physical therapists. Therefore, there is a need for high-quality research showing the effectiveness of trunk exercise methods in consistently reducing low back pain symptoms in patients with nonspecific chronic low back pain. Consequently, the purpose of this study was to investigate the effects of a newly developed exercise program aimed at improving spinal mobility and stability on trunk function and on reducing low back pain in patients with chronic nonspecific low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire regarding low back pain before intervention, 2 weeks after, and 4 weeks after (Numerical rating scale: NRS, Oswestry disability index: ODI)
Key secondary outcomes
Spinal alignment and mobility assessment using Spinal Mouse, multifidus muscle thickness assessment using ultrasound imaging equipment, and spinal erector muscle tissue stiffness assessment using MyotonePRO before intervention, 2 weeks after, and 4 weeks after
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group performs exercises targeting spinal mobility and stability for 10-15 minutes daily.
Interventions/Control_2
The control group performs general trunk exercises for 10-15 minutes daily.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals experiencing low back pain on three or more days per week for three months or longer
Key exclusion criteria
Individuals who can touch the floor with their palms during the standing forward bend test, cannot agree to refrain from initiating other pain relief therapies during the trial period, are pregnant or may be pregnant, have recently given birth or are breastfeeding, may exhibit allergic symptoms to the test product material, with skin abnormalities such as wounds, eczema, or irritation in areas where the test product will come into contact, with organic diseases such as herniated discs, experiencing numbness in the hands or feet, with a history of identified structural spinal abnormalities, with acute (painful) conditions such as spinal fractures or muscle strains, who have participated in another clinical trial within the past month or are currently participating in one, with a BMI of 28 or higher, presently receiving prescription medication for internal medical conditions, who cannot consent to the publication of trial footage for promotional purposes in a manner that prevents personal identification (e.g., by obscuring the face), currently receiving outpatient treatment for low back pain.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Akimi |
| Middle name | |
| Last name | Nakata |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
559-8611
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka
TEL
06-6616-6911
akimi_nakata@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Maekawa |
Organization
Morinomiya University of Medical Sciences
Division name
Department of Medical Technology, Faculty of Medical Science Technology
Zip code
559-8611
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka
TEL
06-6616-6911
Homepage URL
kenkyu@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Akimi Nakata
Funding Source
Organization
MTG Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Health Sciences Research Ethics Review Board
Address
1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka
Tel
06-6616-6911
kenkyu@morinomiya-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
森ノ宮医療大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 27 | 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 | 11 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069112
