UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056092 |
|---|---|
| Receipt number | R000064088 |
| Scientific Title | Low Back Pain Related to Hip Joint Motion Range Limitations and Preventative Measures |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/11/08 09:30:15 |
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Basic information
Public title
Low back pain associated with hip range of motion limitation and preventive measures
Acronym
Measures to prevent lower back pain by improving the range of motion of the hip joint
Scientific Title
Low Back Pain Related to Hip Joint Motion Range Limitations and Preventative Measures
Scientific Title:Acronym
Investigation of hip joint range of motion and lower back pain
Region
| Japan |
Condition
Condition
non-specific low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reserch1: To evaluate the effectiveness of a rehabilitation therapy that focuses on improving flexibility in the range of motion of the hip joint for patients who visited an orthopedic clinic with low back pain as their chief complaint and decreased flexibility in hip and lower leg extension. In this study, I will verify whether hip joint range of motion measurement is effective as a simple method for predicting the risk of low back pain.
Reserch2: Based on the results of Reserch1, I will instruct nurses and caregivers working in nursing care facilities to practice stretching on their own with the main purpose of improving hip joint flexibility, and I will aim to improve low back pain and prevent its onset.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Back pain evaluation will be performed at the first visit and four weeks after rehabilitation using the NRS (numerical rating scale) and JOABPEQ (Japanese Orthopedic Association back pain evaluation questionnaire).The evaluation criteria for JOABPEQ are: 1) if the post-intervention score increases by 20 points or more compared to pre-intervention, 2) if the pre-intervention score was less than 90 points and the post-intervention score reached 90 points or more; if either 1 or 2 is met, it will be judged as "effective," and the relationship between the rate of stretching implementation and hip joint range of motion and improvement in back pain will be compared.
Key secondary outcomes
Both Reserach1 and 2 will also consider the effects of treatments other than rehabilitation and stretching, such as the use of oral medications and external medications.
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
Research1: Measurement of hip joint range of motion (flexion angle, external rotation angle, internal rotation angle), Thomas test, and SLR (Straight Leg Raising) (=measured with a goniometer) at the first consultation, approximately 2 weeks after rehabilitation intervention, and approximately 4 weeks after rehabilitation intervention. ). Regarding rehabilitation, physical therapists and occupational therapists provide exercise therapy to improve trunk and lower limb flexibility (especially improving hip joint range of motion), trunk and buttocks circumference, and antigravity muscle strength, as well as instruction on independent exercises to improve trunk and lower limb flexibility.
Research2: Participants were instructed on eight types of stretching exercises that can be performed by themselves and are effective in increasing hip joint range of motion.Have them practice it at home or at work at least once a day for about four weeks.Using the same method as in Research 1, hip joint range of motion was measured before and after practicing the stretching exercises.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Research1: Men and women aged 18 to 70 years old who visited a clinic in Sendai (Shirakihara Clinic, Minamikoudai, Izumi Ward) with a primary complaint of lower back pain, were diagnosed with non-specific lower back pain (X-ray imaging showed no osteoarthritis of the hip), and received treatment as part of insurance-covered medical care, and who agreed with the purpose of this study and cooperated in providing medical information.
Research2:Male and female nurses and caregivers aged 18 to 70 years old (regardless of whether they have back pain) who work at a care facility (currently undecided) and agree with the purpose of this study.
Key exclusion criteria
Those who are pregnant or may be pregnant.For Research 2, those who have been diagnosed with lumbar disc herniation, lumbar spinal canal stenosis, lumbar spondylolisthesis, or other lumbar diseases, or those with a history of spinal or hip surgery, were excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Irokawa |
Organization
Tohoku Univercity Graduate School of Medicine
Division name
Occupational Health Departmant
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai City, Tohoku University School of Medicine, Building 1, 5th floor, Occupational Health Department
TEL
022-717-7874
toshiya.irokawa.a2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku Univercity Graduate School of Medicine
Division name
Occupational Health Department
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai City, Tohoku University School of Medicine, Building 1, 5th floor,
TEL
022-717-7874
Homepage URL
takahashi.akane.q4@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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 | 12 | Month | 01 | 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
9
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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064088
